qanastek/EMEA-V3 huggingface dataset:
Ranexa 375 mg prolonged-release tablets Ranolazine
Ranexa 375 mg pilloli li jerħu l- mediċina bil- mod Ranolazine
Each prolonged-release tablet contains 375 mg ranolazine.
Kull pillola li terħi l- mediċina bil- mod fiha 375 mg ranolazine.
30 prolonged-release tablets 60 prolonged-release tablets 100 prolonged-release tablets
30 pillola li terħi l- mediċina bil- mod 60 pillola li jerħu l- mediċina bil- mod 100 pillola li terħi l- mediċina bil- mod
Do not chew.
Iblagħha sħiħa, togħmodhiex.
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ)
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
PVC/ PVDC/ Aluminium blisters
Folji PVC/ PVDC/ Aluminju
Carton containing blister strips or carton containing HDPE bottle and bottle label.
Kartuna fiha folji jew kartuna fiha flixkun HDPE u t- tikketta tal- flixkun.
Ranexa 500 mg prolonged-release tablets Ranolazine
Ranexa 500 mg pilloli li jerħu l- mediċina bil- mod Ranolazine
Each prolonged-release tablet contains 500 mg ranolazine.
Kull pillola li terħi l- mediċina bil- mod fiha 500 mg ranolazine.
Contains colouring agent E110; see package leaflet for further information.
Fih is- sustanza li tagħti l- kulur E110; ara l- fuljett ta ’ tagħrif għal aktar tagħrif.
Do not chew.
Iblagħha sħiħa, Togħmodhiex.
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Ranexa 750 mg prolonged-release tablets Ranolazine
Ranexa 750 mg pilloli li jerħu l- mediċina bil- mod Ranolazine
Each prolonged-release tablet contains 750 mg ranolazine.
Kull pillola li terħi l- mediċina bil- mod fiha 750 mg ranolazine.
Contains colouring agent E102 and lactose; see package leaflet for further information.
Fih is- sustanza li tagħti l- kulur E102 u lactose; ara l- fuljett ta ’ tagħrif għal aktar tagħrif.
30 prolonged-release tablets 60 prolonged-release tablets 100 prolonged-release tablets
30 pillola li terħi l- mediċina bil- mod 60 pillola li terħi l- mediċina bil- mod 100 pillola li terħi l- mediċina bil- mod
49 PACKAGE LEAFLET:
49 FULJETT TA ’ TAGĦRIF:
Ranexa 375 mg prolonged-release tablets Ranexa 500 mg prolonged-release tablets Ranexa 750 mg prolonged-release tablets Ranolazine
Ranexa 375 mg pilloli li jerħu l- mediċina bil- mod Ranexa 500 mg pilloli li jerħu l- mediċina bil- mod Ranexa 750 mg pilloli li jerħu l- mediċina bil- mod Ranolazine
In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given Ranexa and during treatment with Ranexa.
Barra minn dan il- fuljett, se tingħata Kard ta ’ Twissija tal- Pazjent, li fiha informazzjoni importanti dwar is- sigurtà li inti teħtieġ li tkun taf qabel ma tingħata Ranexa u matul it- trattament b’ Ranexa.
- Keep this leaflet and the Patient Alert Card.
- Żomm dan il- fuljett u l- Kard ta ’ Twissija tal- Pazjent.
You may need to read it again.
Jista ’ jkollok bżonn terġa ’ taqrahom.
- Always show the Patient Alert Card to any doctor involved in your treatment, including physicians
- Dejjem uri l- Kard ta ’ Twissija tal- Pazjent lil kwalunkwe tabib involut fit- trattament tiegħek, inkluż
treating conditions other than angina pectoris.
tobba li jkunu qegħdin jikkuraw kundizzjonijiet għajr l- anġina pectoris.
- Please make sure you have a list of all your other medicines with you at any visit to a health care
- Jekk jogħġbok kun żgur li jkollok lista tal- mediċini tiegħek kollha l- oħrajn miegħek fi kwalunkwe
professional.
viżra lil professjonist tal- kura tas- saħħa.
In this leaflet 1.
F’ dan il- fuljett:
What Ranexa is and what it is used for 2.
X’ inhi Ranexa u għalxiex tintuża 2.
Before you take Ranexa 3.
Qabel ma tieħu Ranexa 3.
How to take Ranexa 4.
Kif għandek tieħu Ranexa 4.
How to store Ranexa 6.
Kif taħżen Ranexa 6.
WHAT RANEXA IS AND WHAT IT IS USED FOR
X’ INHI RANEXA U GĦALXIEX TINTUŻA
Ranexa is a medicine used in combination with other medicines to treat angina pectoris, which is a chest pain or discomfort that you feel anywhere along the upper part of your body between your neck and upper abdomen, often brought on by exercise or too much activity.
Ranexa hija mediċina wżata f’ kumbinazzjoni ma ’ mediċini oħra biex tikkura anġina pectoris, li hija uġigħ jew dwejjaq fis- sider li tista ’ tħoss fi kwalunkwe parti tal- parti ta ’ fuq ta ’ ġismek bejn għonqok u l- parti ta ’ fuq taż- żaqq, li ta ’ spiss jitqanqal minn eżerċizzju jew minn attività żejda.
BEFORE YOU TAKE RANEXA
QABEL MA TIEĦU RANEXA
Do not take Ranexa
Tiħux Ranexa jekk:
- if you are allergic (hypersensitive) to ranolazine or any of the other ingredients of Ranexa listed in
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal ranolazine jew sustanza oħra ta ’
section 6 of this leaflet.
Ranexa elenkata f’ sezzjoni 6 ta ’ dan il- fuljett
- if you have severe kidney problems.
- jekk għandek problemi bil- kliewi tiegħek
- if you have moderate or severe liver problems.
- jekk għandek problemi moderati jew severi tal- fwied
- if you are using certain medicines to treat bacterial infections (clarithromycin, telithromycin),
- jekk qiegħed tieħu ċerti mediċini biex tikkura infezzjonijiet batteriċi (clarithromycin,
fungal infections (itraconazole, ketoconazole, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e. g. quinidine, dofetilide, or sotalol).
telithromycin), infezzjonijiet fungali (itraconazole, ketoconazole, voriconazol, posaconazol), infezzjoni HIV (impedituri protease), depressjoni (nefazodone) jew disturbi tar- ritmu tal- qalb (eż. quinidine, dofetilide, or sotalol)
Take special care with Ranexa Speak to your doctor before taking Ranexa:
Oqgħod attent ħafna b’ Ranexa Kellem lit- tabib tiegħek qabel ma tieħu Ranexa:
- if you have mild or moderate kidney problems.
- jekk għandek problemi tal- kliewi ħfief jew moderati
- if you have mild liver problems.
- jekk għandek problemi tal- fwied ħfief
- if you have ever had an abnormal electrocardiogram (ECG).
- jekk qatt kellek elettrokardjogramma (ECG) anormali
- if you are elderly.
- jekk inti anzjan
- if you have low weight (60 kg or less).
- jekk għandek piż baxx (60 kg jew anqas)
- if you have heart failure.
- jekk għandek falliment tal- qalb
Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you.
It- tabib tiegħek jista ’ jiddeċiedi biex jagħtik doża aktar baxxa jew jieħu prekawzjonijiet oħra jekk kwalunkwe minn dawn japplikaw għalik.
Using other medicines Do not use the following medicines if you take Ranexa:
Meta tieħu mediċini oħra Tużax il- mediċini li ġejjin jekk tieħu Ranexa:
- certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections
- ċerti mediċini biex tikkura infezzjonijiet batteriċi (clarithromycin, telithromycin), infezzjonijiet
(itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e. g. quinidine, dofetilide, or sotalol).
fungali (itraconazole, ketoconazole, voriconazol, posaconazol), infezzjoni HIV (impedituri protease), depressjoni (nefazodone) jew disturbi tar- ritmu tal- qalb (eż. quinidine, dofetilide, jew sotalol).
Tell your doctor or pharmacist before you take Ranexa if you use:
Għid lit- tabib jew lill- ispiżjar tiegħek qabel tieħu Ranexa jekk tuża:
- certain medicines to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole),
- ċerti mediċini biex tikkura infezzjoni batterika (erythromycin), jew infezzjoni fungali
a medicine used to prevent rejection of a transplanted organ (ciclosporin), or if you are taking some heart tablets such as diltiazem or verapamil.
(fluconazole), mediċina wżata biex timpedixxi r- rifjut ta ’ organu trapjantat (ciclosporin), jew jekk qiegħed tieħu xi mediċini tal- qalb bħal ma huma diltiazem jew verapamil.
These medicines may cause an increase in the number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of Ranexa (see section 4).
Dawn il- mediċini jistgħu jikkaġunaw żieda fin- numru ta ’ effetti sekondarji, bħal ma huma sturdament, dardir, jew remettar, li huma effetti sekondarji possibbli ta ’ Ranexa (ara sezzjoni 4).
Your doctor may decide to give you a lower dose.
It- tabib tiegħek jista ’ jiddeċiedi li jagħtik doża aktar baxxa.
- medicines to treat epilepsy or another neurologic disorder (e. g. phenytoin, carbamazepine, or
- mediċini biex tikkura epilessija jew disturb newroloġiku ieħor (eż. phenytoin, carbamazepine, jew
phenobarbital); are taking rifampicin for an infection (e. g. tuberculosis); or are taking the herbal remedy St.
phenobarbital); jekk qiegħed tieħu rifampicin għall- infezzjoni (eż. tuberculosis); jew jekk qiegħed tieħu r- rimedju erbali St.
John's Wort, as these medicines may cause Ranexa to be less effective.
John' s Wort, peress li dawn il- mediċini jistgħu jikkaġunaw li Ranexa tkun anqas effettiva.
- medicines containing digoxin, as your doctor may want to change your dose whilst you are taking
- mediċini li fihom digoxin, peress li t- tabib tiegħek jaf ikun irid ibiddilek id- doża waqt li qiegħed
Ranexa.
tieħu Ranexa.
- certain medicines to treat allergies (e. g. terfenadine, astemizole, mizolastine), heart rhythm
- ċerti mediċini biex jikkuraw l- allerġiji (eż. terfenadine, astemizole, mizolastine), disturbi tar- ritmu
disorders (e. g. disopyramide, procainamide), and depression (e. g. imipramine, doxepin, amitriptyline), as these medicines may affect your ECG.
tal- qalb (eż. disopyramide, procainamide), u depressjoni (eż. imipramine, doxepin, amitriptyline), peress li dawn il- mediċini jistgħu jeffettwaw l- ECG tiegħek.
- certain medicines to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer
- ċerti mediċini biex jikkuraw id- depressjoni (bupropion), psikożi, infezzjoni HIV (efavirenz), jew
(cyclophosphamide).
kanċer (cyclophosphamide).
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Taking Ranexa with food and drink Ranexa can be taken with or without food.
Meta tieħu Ranexa ma ’ l- ikel u max- xorb Ranexa tista ’ tittieħed ma ’ l- ikel jew fuq stonku vojt.
While being treated with Ranexa, you should not drink grapefruit juice.
Waqt li qiegħed tiġi kkurat b’ Ranexa, m’ għandekx tixrob meraq tal- grejpfrut.
Pregnancy You should not take Ranexa if you are pregnant unless your doctor has advised you to do so.
Tqala Jekk inti tqila, m’ għandekx tieħu Ranexa sakemm it- tabib tiegħek ma takx il- parir li tagħmel dan.
Breast-feeding You should not take Ranexa if you are breast-feeding.
Treddigħ Jekk qegħda tredda ’ m’ għandekx tieħu Ranexa.
Ask your doctor for advice if you are breast- feeding.
Itlob parir lit- tabib tiegħek jekk qiegħda tredda '.
Ask your doctor for advice before using any medicine.
Itlob l- parir tat- tabib tiegħek qabel tieħu xi mediċina.
Driving and using machines No studies on the effects of Ranexa on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sar l- ebda studju fuq l- effetti ta ’ Ranexa fuq il- ħila biex issuq u tħaddem magni.
Ask your doctor for advice about driving or using machines.
Itlob parir mingħand it- tabib tiegħek dwar is- sewqan u t- tħaddim ta ’ magni.
Ranexa may cause side effects such as dizziness (common) and blurred vision (uncommon) that may affect your ability to drive or use machinery.
Ranexa tista ’ tikkaġuna effetti sekondarji bħalma huma sturdament (komuni) u viżta mċajpra (mhux komuni) li jistgħu jeffetwaw il- ħila tiegħek biex issuq jew tuża magni.
If you experience these symptoms, do not drive or operate machinery until they have resolved completely.
Jekk tesperjenza dawn is- sintomi, issuqx jew tħaddimx magni sakemm ikunu rrisolvew kompletament.
Important information about some of the ingredients of Ranexa The 500 mg prolonged-release tablets contain the azo colouring agent E110, and the 750 mg prolonged-release tablets contain the azo colouring agent E102.
51 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ranexa Il- pilloli ta ’ 500 mg li jerħu l- mediċina bil- mod fihom is- sustanza ta ’ kulur azo E110, u l- pilloli ta ’ 750 mg li jerħu l- mediċina bil- mod fihom is- sustanza ta ’ kulur azo E102.
These colouring agents may cause allergic reactions.
Dawn is- sustanzi ta ’ kulur jistgħu jikkaġunaw reazzjonijiet allerġiċi.
51 The 750 mg prolonged-release tablets contain lactose monohydrate.
Il- pilloli ta ’ 750 mg li jerħu l- mediċina bil- mod fihom lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE RANEXA
KIF GĦANDEK TIEĦU RANEXA
Always take Ranexa exactly as your doctor has told you to.
Dejjem għandek tieħu Ranexa skond il- parir tat- tabib.
Always swallow the tablets whole with water.
Dejjem ibla ’ l- pilloli sħaħ ma ’ l- ilma.
Do not crush, suck, or chew the tablets or break them in half, as this might affect the way the medicine is released from the tablets into your body.
Tgħaffiġx, terdagħx, jew togħmodx il- pilloli jew taqsamhomx minn nofs, għaliex dan jista ’ jaffettwa l- mod kif il- mediċina tinħeles minn ġol- pilloli għal ġo ġismek.
The starting dose for adults is one 375 mg tablet twice a day.
Id- doża tal- bidu għall- adulti hija pillola ta ’ 375 mg darbtejn kuljum.
After 2− 4 weeks, your doctor may increase the dose to get the right effect.
Wara 2−4 ġimgħat, it- tabib tiegħek jista ’ jżid id- doża biex jikseb l- effett it- tajjeb.
The maximum dose of Ranexa is 750 mg twice a day.
Id- doża massima ta ’ Ranexa hija 750 mg darbtejn kuljum.
It is important that you tell your doctor if you get side effects such as dizziness or feeling or being sick.
Huwa importanti li tgħid lit- tabib tiegħek jekk ikollok xi effetti sekondarji bħalma huma sturdament jew tħossok imdardar jew jekk tirremetti.
Your doctor may lower your dose or, if this is not sufficient, stop treatment with Ranexa.
It- tabib tiegħek jista ’ jbaxxi d- doża tiegħek jew, jekk dan mhuwiex biżżejjed, iwaqqaf il- kura b’ Ranexa.
Children and adolescents under 18 years old should not take Ranexa.
Tfal u adoloxxenti taħt it- 18- il sena ma għandhomx jieħdu Ranexa.
If you take more Ranexa than you should If you accidentally take too many Ranexa tablets or take a higher dose than recommended by your doctor, it is important that you tell your doctor at once.
Jekk tieħu Ranexa aktar milli suppost Jekk aċċidentalment tieħu żżejjed pilloli Ranexa jew tieħu doża aktar għolja milli rrakkomanda t- tabib tiegħek, huwa importanti li tgħid lit- tabib tiegħek minnufih.
If you cannot contact your doctor, go to the nearest accident and emergency department.
Jekk ma tistax taqbad lit- tabib tiegħek, mur fl- eqreb dipartiment ta ’ l- emerġenza.
Take along any tablets that are left, including the container and the carton, so that the hospital staff can easily tell what you have taken.
Ħu miegħek kwalunkwe pillola li jkun baqalek, inklużi l- kontenitur u l- kartuna, sabiex l- impjegati ta ’ l- isptar ikunu jistgħu jagħrfu malajr xi tkun ħadt.
If you forget to take Ranexa If you forget to take a dose, take it as soon as you remember unless it is nearly time to take your next dose.
Jekk tinsa tieħu Ranexa Jekk tinsa tieħu doża, ħudha mill- aktar fis kif tiftakar sakemm ma jkunx wasal il- ħin tad- doża ta ’ wara.
Like all medicines, Ranexa can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Ranexa jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These are usually mild or moderate.
Huma ġeneralment ħfief jew moderati.
You should stop taking Ranexa and see your doctor immediately if you experience the following symptoms of angioedema, which is a rare condition but can be severe: • swollen face, tongue, or throat • difficulty swallowing • hives or difficulty breathing
Għandek tieqaf tieħu Ranexa u tara lit- tabib tiegħek minnufih jekk tesperjenza s- sintomi li ġejjin ta ’ anġjoedima, li hija kundizzjoni rari iżda li tista ’ tkun severa: • Wiċċ, ilsien jew ġerżuma minfuħin • Diffikultà biex tibla ’ • Urtikarja jew diffikultà biex tieħu n- nifs
Tell your doctor if you experience common side effects such as dizziness or feeling sick or vomiting.
Għid lit- tabib tiegħek jekk tesperjenza effetti sekondarji komuni bħalma huma sturdament jew dardir jew remettar.
Your doctor may lower your dose or stop treatment with Ranexa.
It- tabib tiegħek jista ’ jbaxxi d- doża tiegħek jew iwaqqaf il- kura b’ Ranexa.
Other side effects you may experience include the following:
Effetti sekondarji oħra li tista ’ tesperjenza jinkludu dawn li ġejjin:
Common side effects (occur in 1 to 10 users in 100) are:
52 Effetti sekondarji komuni (iseħħu f’ 1 sa 10 pazjenti minn kull 100) huma:
Constipation Dizziness Headache Feeling sick, vomiting Feeling weak
Stitikezza Sturdament Uġigħ ta ’ ras Dardir, rimettar Tħossok dgħajjef
52 Uncommon side effects (occur in 1 to 10 users in 1,000) are:
Effetti sekondarji mhux komuni (iseħħu f’ 1 sa 10 pazjenti minn kull 1, 000) huma:
Anxiety, difficulty sleeping Blurred vision, visual disturbance Changes in sensation (touch or taste), tremor, feeling tired or sluggish, sleepiness or drowsiness, faint or fainting, dizziness upon standing Dark urine, blood in urine, difficulty urinating Dehydration Difficulty breathing, cough, nose bleed Excessive sweating, itching Feeling swollen or bloated Hot flushes, low blood pressure Increases in a substance called creatinine or increases in urea in your blood, increase in blood platelets or white blood cells, changes in ECG heart tracing Joint swelling, pain in extremity Loss of appetite and/ or weight loss Muscle cramp Ringing in the ears and/ or feeling a spinning sensation Stomach pain or discomfort, indigestion, dry mouth, or wind
Ansjetà, diffikultà fl- irqad Viżjoni mċajpra, disturbi viżwali Bidliet f’ sensazzjoni (mess jew togħma), rogħda, għeja jew bla ħeġġa, ngħas, tħossok se jħossok ħażin, sturdament malli tqum Awrina skura, demm fl- awrina, diffikultà biex tgħaddi l- awrina Deidratazzjoni Diffikultà fit- teħid tan- nifs, sogħla, fsada fl- imnieħer Ħruġ eċċessiv ta ’ għaraq, ħakk Tħossok minfuħ jew mimli bl- ilma Fwawar, pressjoni tad- demm baxxa Żidiet f’ sustanza msejjħa kreatinina jew żidiet fil- ureja f’ demmek, żieda fil- platelets tad- demm jew fiċ- ċelloli tad- demm bojod, tibdil fl- intraċċar tal- qalb bl- ECG Nefħiet fil- ġogi, uġigħ fl- estremità Telf ta ’ aptit u/ jew telf ta ’ piż Bugħawwieġ Ċempil fil- widnejn u/ jew sensazzjoni ta ’ tidwir Skumdità jew uġigħ fl- istonku, indiġestjoni, ħalq xott, jew gass
Rare side effects (occur in 1 to 10 users in 10,000) are:
Effetti sekondarji rari (iseħħu f’ 1 sa 10 utenti minn kull 10, 000) huma:
Abnormal laboratory values for liver Change in sense of smell, numbness in mouth or lips, impaired hearing Cold sweat, rash Decrease in blood pressure upon standing Decreased or loss of consciousness Disorientation Feeling of coldness in hands and legs Hives, allergic skin reaction Impotence Inflammation of pancreas or intestine Loss of memory Throat tightness
Valuri tal- laboratorju annormali għal fwied Bidla fis- sens tax- xamm, tirżiħ fil- ħalq jew xofftejn, smigħ indebolit Għaraq kiesaħ, raxx Inżul tal- pressjoni tad- demm malli wieħed iqum bil- wieqfa Tnaqqis jew telf tas- sensi Disorjentazzjoni Sensazzjoni ta ’ kesħa fl- idejn u r- riġlejn Ħorriqija, reazzjoni allerġika tal- ġilda Impotenza Infjammazzjoni tal- pankreas jew intestini Telf tal- memorja, Skumdità fil- griżmejn
HOW TO STORE RANEXA
KIF TAĦŻEN RANEXA
Keep out of the reach and sight of children.
Żommu fejn ma tintaħaqx u ma tidhirx mit- tfal.
Do not use Ranexa after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle.
Tużax Ranexa wara d- data ta ’ skadenza li tidher fuq kull folja ta ’ pilloli u fuq in- naħa ta ’ barra tal- kartuna u l- flixkun.
This medicinal product does not require any special storage conditions.
Din il- mediċina ma teħtieġ l- ebda kundizzjonijiet speċjali ta ’ ħażna.
What Ranexa contains The active substance in Ranexa is ranolazine.
X’ fiha Ranexa Is- sustanza attiva f’ Ranexa hija ranolazine.
Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.
Kull pillola fiha 375 mg, 500 mg, jew 750 mg ta ’ ranolazine.
53 The other ingredients are: hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.
Is- sustanzi l- oħra huma: hypromellose, magnesium stearate, methacrylic acid- ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide u carnauba wax.
Depending on the tablet strength, the tablet coatings also contain:
Jiddependi fuq il- qawwa tal- pillola, il- kisjiet tal- pilloli fihom ukoll:
375 mg tablet: polyethylene glycol, polysorbate 80, Blue #2/ Indigo Carmine Aluminium Lake (E132) 500 mg tablet: polyethylene glycol, polysorbate 80, Yellow #6/ Sunset Yellow FCF Aluminium Lake (E110) 750 mg tablet: glycerol triacetate, lactose monohydrate, Blue #1/ Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/ Tartrazine Aluminium Lake (E102)
Pillola 375 mg: polyethylene glycol, polysorbate 80, Blu # 2/ Indigo Carmine Aluminium Lake (E132) Pillola 500 mg: polyethylene glycol, polysorbate 80, Isfar # 6/ Sunset Yellow FCF Aluminium Lake (E110) Pillola 750 mg: glycerol triacetate, lactose monohydrate, Blu # 1/ Brilliant Blue FCF Aluminium Lake (E133) and Isfar # 5/ Tartrazine Aluminium Lake (E102)
What Ranexa looks like and contents of the pack Ranexa prolonged-release tablets are oval shaped tablets.
Ranexa huma pilloli ovali li jerħu l- mediċina bil- mod.
The 375 mg tablets are pale blue and are engraved with CVT375 on one side.
Il- pilloli ta ’ 375 mg huma ċelesti u minquxin b’ CVT375 fuq naħa waħda.
The 500 mg tablets are light orange and are engraved with CVT500 on one side.
Il- pilloli ta ’ 500 mg huma oranġjo ċari u minquxin b’ CVT500 fuq naħa waħda.
The 750 mg tablets are pale green and are engraved with CVT750 on one side.
Il- pilloli ta ’ 750 mg huma ħodor ċari u minquxin b’ CVT750 fuq naħa waħda.
Ranexa is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles.
Ranexa hija fornuta f’ pakketti li fihom 30, 60, jew 100 pillola fi folji jew 60 pillola fi fliexken tal- plastik.
Marketing Authorisation Holder Menarini International Operations Luxembourg S. A.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Menarini International Operations Luxembourg S. A.
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
1, Avenue de la Gare, L- 1611 Luxembourg, Il- Lussemburgu
Manufacturer Brecon Pharmaceuticals Ltd Pharos House, Wye Valley Business Park Hay-on-Wye Hereford HR3 5PG United Kingdom
Manifattur Brecon Pharmaceuticals Ltd Pharos House, Wye Valley Business Park Hay- on- Wye Hereford HR3 5PG Ir- Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
55 This leaflet was last approved in {MM/YYYY}.
Dan il- fuljett ġie approvat l- aħħar fi {XX/ SSSS}.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Content
(konċentraz zjoni)
1 bottle + 30 syringes + 1 syringe adapter + 1 carrying case
Flixkun 1 + 30 siringa + 1 adapter tas- siringa + 1 valiġġa biex ġġorr
blister (PVC/ PE/ Aclar/ alu)
folja (PVC/ PE/ Aclar/ alu)
blister (PVC/ PE/ Aclar/ alu)
Folja (PVC/ PE/ Aclar/ alu)
What is Rapamune?
X’ inhu Rapamune?
Rapamune is a medicine that contains the active substance sirolimus.
Rapamune huwa mediċina li fiha s- sustanza attiva sirolimus.
It is available as an oral solution (1 mg/ ml) and triangular tablets (white:
Huwa disponibbli f’ soluzzjoni orali (1 mg/ ml) u bħala pilloli trijangulari (bojod:
1 mg; yellow:
1 mg: sofor:
2 mg).
2 mg)
What is Rapamune used for?
Għal xiex jintuża Rapamune?
Rapamune is used to prevent the body from rejecting a newly transplanted kidney.
Rapamune jintuża biex ma jħallix lill- ġisem jirrifjuta kilwa li tkun għada kif ġiet trapjantata.
It is used in adults who are at a low to moderate risk of rejection.
Huwa jintuża fl- adulti li huma f’ riskju ta ’ rifjut li jvarja minn baxx għal moderat.
It is recommended that Rapamune be used with ciclosporin and corticosteroids (other medicines to prevent organ rejection) for two to three months.
Huwa rrakkomandat li Rapamune jintuża maċ- ċiklosporina (ciclosporin) u kortikosterojdi (mediċini oħrajn biex jimpedixxu rifjut tal- organi) għal xahrejn sa tlieta.
After this period, Rapamune can be used as maintenance treatment together with corticosteroids, but only if ciclosporin treatment can be stopped.
Wara dan il- perjodu, Rapamune jista ’ jintuża bħala trattament ta ’ manteniment flimkien ma ’ kortikosterojdi, iżda biss jekk it- trattament b’ ċiklosporina ikun jista ’ jitwaqqaf.
How is Rapamune used?
Kif jintuża Rapamune?
Rapamune treatment should be started by and remain under the guidance of a doctor who is a qualified specialist in transplantation.
It- trattament b’ Rapamune għandu jinbeda minn u jibqa ’ taħt il- gwida ta ’ tabib speċjalista, ikkwalifikat fit- trapjanti.
Rapamune is given as an initial dose of 6 mg as soon as possible after the transplant, followed by 2 mg once a day for two to three months.
Rapamune jingħata bħala doża tal- bidu ta ’ 6mg mill- aktar fis possibbli wara t- trapjant, segwit minn 2mg darba kuljum għal xahrejn sa tliet xhur.
The levels of sirolimus in the patient’ s blood should be monitored, and the dose adjusted to produce the appropriate levels (4 to 12 ng/ ml).
Il- livelli ta ’ sirolimus fid- demm għandhom jiġu sorveljati, u d- doża għandha tiġi aġġustata biex tipproduċi l- livelli xierqa (4 sa 12 ng/ ml).
Rapamune should be taken four hours after each ciclosporin dose.
Rapamune għandu jittieħed erba ’ sigħat wara kull doża ta ’ ċiklosporina.
Patients should always take Rapamune consistently, either with or without food.
Il- pazjenti għandhom dejjem jieħdu Rapamune konsistentement, jew mal- ikel jew fuq stonku vojt.
After this period, Rapamune can be used as ‘ maintenance therapy ’ in patients who are able to stop ciclosporin.
Wara dan il- perijodu, Rapamune jista ’ jintuża bħala ‘ terapija ta ’ manteniment ’ f’ pazjenti li jistgħu jwaqqfu ċiklosporina.
In these cases, the dose of ciclosporin should be gradually reduced to zero over four to eight weeks, and the dose of Rapamune increased to obtain blood levels of sirolimus of about 12 to 20 ng/ ml.
F’ dawn il- każijiet, id- doża ta ’ ċiklosporina għandha titnaqqas gradwalment għal żero fuq erbgħa sa tmien ġimgħat, u d- doża ta ’ Rapamune għandha tiżdied biex tikseb livelli ta ’ sirolimus ta ’ madwar 12 sa 20 ng/ ml.
On average, the dose of Rapamune needs to be increased fourfold.
Id- doża ta ’ Rapamune jeħtieġ tiżdied b’ medja għal erba ’ darbiet.
The available information on Rapamune’ s safety and effectiveness in patients below 18 years of age is not sufficient to recommend the medicine ’ s use in this age group.
It- tagħrif disponibbli dwar is- sigurtà u l- effikaċja ta ’ Rapamune fil- pazjenti li jkunu taħt it- 18- il sena mhux suffiċjenti sabiex jiġi rrakkomandat l- użu ta ’ din il- mediċina f’ dan il- grupp ta ’ età.
How does Rapamune work?
Kif jaħdem Rapamune?
The active substance in Rapamune, sirolimus, is an immunosuppressive agent.
Is- sustanza attiva f’ Rapamune, sirolimus, hija mediċina immunosoppressiva.
This complex then blocks mTOR.
Hija taħdem billi timblokka proteina msejħa ‘ mira tar- rapamiċina speċifika għall- mammiferi ’ (mammalian target of rapamycin ’) (mTOR).
Since mTOR is involved in the multiplication of activated T-lymphocytes (white blood cells that are responsible for 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Fil- ġisem sirolimus jeħel ma ’ proteina li tinsab fiċ- ċelloli biex jagħmel 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. attacking the transplanted organ), Rapamune reduces the number of these cells, reducing the risk of organ rejection.
Dan il- kumpless imbagħad jimblokka mTOR.
How has Rapamune been studied?
Kif ġie studjat Rapamune?
Rapamune has been studied in two main studies involving a total of 1,295 patients who were having a kidney transplant and were at low to moderate risk of rejection.
Rapamune ġie studjat f’ żewġ studji ewlenin li involvew total ta ’ 1, 295 pazjent li kien qed ikollhom trapjant tal- kilwa u kienu f’ riskju ta ’ rifjut li jvarja minn baxx għal moderat.
The studies compared two doses of Rapamune oral solution with azathioprine (another anti-rejection medicine) in the first study (719 patients), and with placebo (a dummy treatment) in the second study (576 patients).
L- istudji qabblu żewġ dożi ta ’ soluzzjoni orali ta ’ Rapamune ma ’ azathioprine (mediċina oħra kontra r- rifjut) fl- ewwel studju (719- il pazjent), u bi plaċebo (trattament finta) fit- tieni studju (576 pazjent).
The medicines were used as an add-on to ciclosporin and corticosteroids.
Il- mediċini ntużaw bħala żieda ma ’ ċiklosporina u kortikosterojdi.
The effectiveness was measured by looking at the number of treatment failures (rejection or loss of the new kidney, or death) after six months.
L- effikaċja tal- mediċina tkejlet abbażi tan- numru ta ’ każijiet fejn it- trattament ma rnexxiex (rifjut jew telf tal- kilwa, jew mewt) wara sitt xhur.
Two studies looked at Rapamune as maintenance treatment for up to five years in a total of 765 patients who had responded to an initial two- to three-month course of treatment and who were able to stop their dose of ciclosporin.
Żewġ studji eżaminaw Rapamune bħala trattament ta ’ manteniment sa żmien ħames snin f’ total ta ’ 765 pazjent li kienu rrispondew għall- kors inizjali ta ’ trattament li jdum minn xahrejn sa tliet xhur u li kienu jistgħu jwaqqfu d- doża tagħhom ta ’ ċiklosporina.
One additional study compared the effectiveness of the oral solution and the tablets.
Studju addizzjonali qabbel l- effikaċja tas- soluzzjoni orali u l- pilloli.
What benefit has Rapamune shown during the studies?
X’ benefiċċju wera Rapamune waqt l- istudji?
Rapamune was more effective than placebo and as effective as azathioprine, when they were added to ciclosporin and corticosteroids.
Rapamune kien aktar effikaċi minn plaċebo u effikaċi daqs azathioprine, meta kienu miżjudin ma ’ ċiklosporina u kortikosterojdi.
In the first study, 19% of the patients adding the approved dose of Rapamune had failed treatment after six months (53 out of 284), compared with 32% of those adding azathioprine (52 out of 161).
Fl- ewwel studju, 19% tal- pazjenti li żiedu d- doża approvata ta ’ Rapamune ma rnexxilhomx it- trattament wara sitt xhur (53 minn 284), meta mqabbla ma ’ 32% ta ’ dawk li żiedu azathioprine (52 minn 161).
In the second study, fewer patients adding Rapamune failed treatment (30%; 68 out of 277) than those adding placebo (48%; 62 out of 130).
Fit- tieni studju, kien hemm inqas pazjenti li ma rnexxielhomx it- trattament meta żiedu Rapamune (30%, 68 minn 277) meta mqabbla ma ’ dawk li żiedu plaċebo (48%, 62 minn 130).
The maintenance studies showed that long-term treatment with Rapamune was effective in helping the new kidney to survive, with an improvement in how well the new kidney worked and an improvement in blood pressure when ciclosporin treatment was stopped.
L- istudji ta ’ manteniment urew li trattament fuq tul ta ’ żmien b’ Rapamune kienet effikaċi f’ li jgħin il - kilwa l- ġdida tissopravivi, b’ titjib f’ kemm il- kilwa l- ġdida kienet tiffunzjona tajjeb u b’ titjib fil - pressjoni tad- demm meta twaqqaf it- trattament b’ ċiklosporina.
The additional study showed that the oral solution and the tablets were equally effective in preventing rejection.
L- istudju addizzjonali wera li s- soluzzjoni orali u l- pilloli kienu effikaċi ndaqs f’ li jimpedixxu r- rifjut.
What is the risk associated with Rapamune?
X’ inhu r- riskju assoċjat ma ’ Rapamune?
The most common side effects with Rapamune (seen in more than 1 patient in 10) are urinary tract infection (infection of the structures that carry urine), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), hypophosphataemia (low blood phosphate levels), hypercholesterolaemia (high blood cholesterol levels), hyperglycaemia (high blood sugar levels), hypertriglyceridaemia (high blood levels of triglycerides, a type of fat), headache, lymphocele (fluid collection around the kidney), hypertension (high blood pressure), abdominal (tummy) pain, diarrhoea, constipation, nausea (feeling sick), acne (spots), arthralgia (joint pain), peripheral oedema (swelling, usually in the legs), pyrexia (fever), pain, increased blood lactate dehydrogenase levels (a marker of tissue breakdown) and increased blood creatinine levels (a marker of kidney problems).
L- aktar effetti sekondarji komuni b’ Rapamune (dehru f’ aktar minn pazjent 1 minn kull 10) huma infezzjoni tal- passaġġi urinarji (infezzjoni tal- istrutturi li jġorru l- awrina), tromboċitopenija (għadd baxxi ta ’ pjastrini), anemija (għadd baxx taċ- ċelloli ħomor tad- demm), ipokaljemija (livelli baxxi ta ’ potassju fid- demm), ipofosfatemija (livelli baxxi ta ’ fosfat fid- demm), iperkolesterolemija (livelli għoljin ta ’ kolesterol fid- demm), ipergliċemija (livelli għoljin ta ’ zokkor fid- demm), ipertrigliċeridemija (livelli għoljin ta ’ trigliċeridi fid- demm, tip ta ’ xaħam), uġigħ ta ’ ras, linfoċele (akkumulu ta ’ fluwidu madwar il- kilwa), ipertensjoni (pressjoni tad- demm għolja), uġigħ addominali (ta ’ żaqq), dijarrea, stitikezza, nawżea (dardir) akne (ponot), artralġija (uġigħ fil- ġogi), edema periferika (nefħa, ġeneralment fir- riġlejn), piressija (deni), uġigħ, żieda fil- livelli ta ’ lattat deidroġenażi (lactate dehydrogenase) fid- demm (indikatur ta ’ tkissir tat- tessut) u żieda fil- livelli ta ’ kreatinina fid- demm (li jindika problemi fil- kliewi).
Because it reduces the activity of the immune system, Rapamune can also increase the risk of developing cancer, especially lymphoma and skin cancer.
Minħabba li jnaqqas l- attività tas- sistema immunitarja, Rapamune jista ’ jżid ukoll ir- riskju ta ’ żvilupp ta ’ kanċer, speċjalment linfoma u kanċer tal- ġilda.
For the full list of all side effects reported with Rapamune, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati b’ Rapamune, ara l- Fuljett ta ’ Tagħrif.
Rapamune should not be used in people who may be hypersensitive (allergic) to sirolimus or any of the other ingredients.
Rapamune m’ għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal sirolimus jew għal xi sustanza oħra tiegħu.
Caution is also needed when Rapamune is taken at the same time as other medicines.
Jeħtieġ ukoll kawtela meta jittieħed Rapamune fl- istess waqt ma ’ mediċini oħrajn.
See the Package Leaflet for further details.
Ara l- Fuljett ta ’ Tagħrif għal aktar dettalji.
Why has Rapamune been approved?
Għaliex ġie approvat Rapamune?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rapamune’ s benefits are greater than its risks for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Rapamune huma akbar mir- riskji tiegħu għal profilassi ta ’ rifjut ta ’ organi f’ pazjenti adulti li jkunu qegħdin jirċievu trapjant renali f’ riskju immunoloġiku baxx għal moderat.
The Committee recommended that Rapamune be given marketing authorisation.
Il- Kumitat irrakkomanda li Rapamune jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Rapamune:
Tagħrif ieħor dwar Rapamune:
The European Commission granted a marketing authorisation valid throughout the European Union for Rapamune to Wyeth Europa Ltd. on 14 March 2001.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Rapamune valida fl- Unjoni Ewropea kollha lil Wyeth Europa Ltd. fl- 14 ta ’ Marzu 2001.
The marketing authorisation was renewed on 14 March 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 14 ta ’ Marzu 2006.
The full EPAR for Rapamune can be found here.
2/ 3 L- EPAR sħiħ għal Rapamune jista ’ jiġi kkonsultat hawn.
2/ 2 This summary was last updated in 11-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
NAME OF THE MEDICINAL PRODUCT
Rapamune 1 mg/ ml soluzzjoni orali.
Each ml contains 1 mg sirolimus.
Kull ml għandu 1 mg sirolimus.
Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant.
Rapamune hu indikat għal prevenzjoni ta ’ riġettazzjoni ta ’ organi f’ pazjenti adulti li għandhom riskju immunoloġiku minn baxx għal moderat li jirċievu trapjant renali.
It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months.
Hu rakkomandat li għall- ewwel Rapamune jingħata flimkien ma ’ mikroemulsjoni ta ’ ciclosporin u ta ’ kortikosterojdi għal bejn 2 u 3 xhur.
Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued (see sections 4.2 and 5.1).
Rapamune jista ’ jitkompla bħala terapija ta ’ manteniment flimkien ma ’ kortikosterojdi, dejjem jekk il- mikroemulsjoni ta ’ ciclosporin tista ’ tiġi progressivament imwaqqfa (ara sezzjonijiet 4. 2 u 5. 1).
Rapamune is for oral use only.
Rapamune huwa għall- użu orali biss.
Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation.
It- trattament għandu jinbeda u għandu jibqa ’ taħt il- ħarsien ta ’ speċjalista adattat u kwalifikat fit- trapjant.
Use in adults Initial therapy (2 to 3 months post-transplantation):
Użu fl- adulti Terapija tal- bidu (minn xahrejn sa 3 xhur wara t- trapjant):
The usual dosage regimen for Rapamune is a 6 mg oral loading dose, administered as soon as possible after transplantation, followed by 2 mg once daily.
Id- doża normalment rakkomandata għal kors ta ’ terapija ta ’ Rapamune hija doża inizjali qawwija ta ’ 6 mg meħuda mill- ħalq, li tingħata kemm jista ’ jkun malajr wara t- trapjant, u segwita b’ 2 mg darba kuljum.
The Rapamune dose should then be individualised, to obtain whole blood trough levels of 4 to 12 ng/ ml (chromatographic assay; see Therapeutic drug monitoring).
Id- doża ta ’ Rapamune trid imbagħad tkun assenjata għall- individwu, sakemm jintlaħaq il- livell l- aktar baxx ta ’ bejn 4 sa 12 ng/ ml fid - demm (assaġġ kromatografiku; ara Monitoraġġ tal- mediċina terapewtika).
Rapamune therapy should be optimised with a tapering regimen of steroids and ciclosporin microemulsion.
It- terapija ta ’ Rapamune għandha tilħaq l- aħjar kundizzjoni bi tnaqqis skont skeda programmata ta ’ sterojdi u mikroemulsjoni ta ’ ciclosporin.
Suggested ciclosporin trough concentration ranges for the first 2-3 months after transplantation are 150-400 ng/ ml (monoclonal assay or equivalent technique).
Il- livelli suġġeriti tal- konċentrazzjoni l- aktar baxxa ta ’ ciclosporin għall- ewwel 2- 3 xhur wara t- trapjant, huma bejn 150- 400 ng/ ml (analiżi monoklonali jew xi tip ta ’ analiżi simili).
Maintenance Therapy:
Terapija ta ’ manteniment:
Ciclosporin should be progressively discontinued over 4 to 8 weeks and the Rapamune dose should be adjusted to obtain whole blood trough levels of 12 to 20 ng/ ml (chromatographic assay; see Therapeutic drug monitoring).
Ciclosporin għandu jitwaqqaf gradwalment fuq perjodu ta ’ minn 4 sa 8 ġimgħat u d- doża ta ’ Rapamune għandha tkun aġġustata biex tikseb l- inqas livell ta ’ 12 sa 20 ng/ ml fid- demm (assaġġ kromatografiku; ara Monitoraġġ tal- mediċina terapewtika).
Rapamune should be given with corticosteroids.
Rapamune għandu jingħata ma ’ kortikosterojdi.
In patients for whom ciclosporin withdrawal is either unsuccessful or cannot be attempted, the combination of ciclosporin and Rapamune should not be maintained for more than 3 months post-transplantation.
F’ pazjenti li għalihom ciclosporin ma jistax jitwaqqaf, jew ma jistax jintuża, il- kombinazzjoni ta ’ ciclosporin u ta ’ Rapamune m’ għandiex titkompla għal aktar minn 3 xhur wara t- trapjant.
In such patients, when clinically appropriate, Rapamune should be discontinued and an alternative immunosuppressive regimen instituted.
F’ pazjenti bħal dawn, meta hu klinikalment adekwat, Rapamune għandu jitwaqqaf u jinbeda xi kors ta ’ kura alternattiva maħsuba biex tnaqqas l- immunità.
2 Use in black recipients:
Użu f’ pazjenti ta ’ razza sewda:
There is limited information indicating that black renal transplant recipients (predominantly African-American) require higher doses and trough levels of sirolimus to achieve the same efficacy as observed in non-black patients.
Teżisti informazzjoni limitata, li tindika li benefiċjarji suwed ta ’ trapjanti renali (fil- maġġoranza Amerikani- Afrikani) jeħtieġu li d- dożi u l- livelli l- aktar baxxi ta ’ sirolimus ikunu ogħla, sabiex tintlaħaq l- istess effikaċja osservata f’ pazjenti li mhumiex suwed.
Currently, the efficacy and safety data are too limited to allow specific recommendations for use of sirolimus in black recipients.
Bħalissa t- tagħrif miġbur, dwar kemm hu effikaċi u sikur l- użu ta ’ sirolimus, hu limitat wisq biex isiru rakkomandazzjonijiet speċifiċi għall- użu ta ’ din il- mediċina f’ pazjenti suwed.
Use in children and adolescents (< 18 years):
2 Użu fi tfal u fl- addolexxenti (< 18- il sena):
The available data on safety and efficacy are not sufficient to recommend the use of Rapamune in children and adolescents less than 18 years of age (see sections 4.8 and 5.1).
Id- dejta disponibbli dwar is- sigurtà u l- effikaċja mhijiex biżżejjed biex ikun rakkomandat l- użu ta ’ Rapamune fit- tfal u fl- addolexxenti li għandhom inqas minn 18- il sena (ara sezzjonijiet 4. 8 u 5. 1).
Limited pharmacokinetic information is available in children and adolescents (see section 5.2).
L- informazzjoni farmakokinetika dwar l- użu ta ’ din il- mediċina fit- tfal u adolexxenti hi limitata (ara sezzjoni 5. 2).
Use in elderly patients (> 65 years):
Użu f’ pazjenti anzjani (> 65 sena):
Clinical studies of Rapamune did not include a sufficient number of patients > 65 years of age to determine whether they will respond differently than younger patients.
Fl- istudji kliniċi ta ’ Rapamune, ma kienx hemm numru suffiċjenti ta ’ pazjenti anzjani > 65 sena, biex tkun tista ’ tgħid jekk jirrispondux differenti minn pazjenti ta ’ età iżgħar.
Sirolimus trough concentration data in 35 renal transplant patients > 65 years of age were similar to those in the adult population (n=822) from 18 to 65 years of age.
F’ 35 każ ta ’ trapjant renali f’ pazjenti ta ’ > 65 sena, l- informazzjoni dwar il- konċentrazzjoni l - aktar baxxa ta ’ sirolimus, kienet simili għal dawk f’ popolazzjoni adulta (n=822) fl- età ta ’ bejn 18 u 65 sena.
Use in patients with renal impairment:
Użu f’ pazjenti b’ indeboliment tal- kliewi:
No dosage adjustment is required (see section 5.2).
L- ebda aġġustament fid- doża ma hi meħtieġa (ara sezzjoni 5. 2).
Use in patients with hepatic impairment:
Użu f’ pazjenti b’ indeboliment epatiku:
The clearance of sirolimus may be reduced in patients with impaired hepatic function (see section 5.2).
It- tneħħija ta ’ sirolimus għandha mnejn tiġi mnaqqsa f’ pazjenti li għandhom indeboliment fil- funzjoni tal- fwied (ara sezzjoni 5. 2).
In patients with severe hepatic impairment, it is recommended that the maintenance dose of Rapamune be reduced by approximately one half.
Huwa rakkomandat li d- doża ta ’ manteniment ta ’ Rapamune titnaqqas b’ madwar nofs f’ pazjenti li għandhom indeboliment epatiku sever.
It is recommended that sirolimus whole blood trough levels be closely monitored in patients with impaired hepatic function (see Therapeutic drug monitoring).
Huwa rakkomandat li l- aktar livelli baxxi ta ’ sirolimus fid- demm sħiħ, ikunu mmonitorjati bir- reqqa f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied (ara Monitoraġġ tal- mediċina terapewtika).
It is not necessary to modify the Rapamune loading dose.
M’ hux neċessarju li d- doża ta ’ Rapamune li tingħata inizjalment tkun modifikata.
Therapeutic drug monitoring:
Monitoraġġ tal- mediċina terapewtika:
Most patients who received 2 mg of Rapamune 4 hours after ciclosporin had whole blood trough concentrations of sirolimus within the 4 to 12 ng/ ml target range (expressed as chromatographic assay values).
Ħafna mill- pazjenti li rċevew 2 mg ta ’ Rapamune 4 sigħat wara ciclosporin kellhom livelli l- aktar baxxi tal- konċentrazzjoni ta ’ sirolimus fid- demm sħiħ ta ’ bejn 4 sa 12 ng/ ml tal- medda mixtieqa (imfissra bħala valuri ta ’ assaġġi kromatografiċi).
Optimal therapy requires therapeutic drug concentration monitoring in all patients.
It- terapija ideali tirrikjedi monitoraġġ tal- konċentrazzjoni tal- mediċina terapewtika fil- pazjenti kollha.
Whole blood sirolimus levels should be closely monitored in the following populations:
Il- livell ta ’ sirolimus fid- demm sħiħ għandu jiġi mmonitorjat mill- qrib f’ dawn il- popolazzjonijiet:
(1) in patients with hepatic impairment; (2) when inducers or inhibitors of CYP3A4 are concurrently administered and after their discontinuation (see section 4.5); and/ or (3) if ciclosporin dosing is markedly reduced or discontinued, as these populations are most likely to have special dosing requirements.
(1) f’ pazjenti b’ indeboliment tal- fwied; (2) meta indutturi jew impedituri ta ’ CYP3A4 jingħataw flimkien u wara li jitwaqqfu (ara sezzjoni 4. 5); u/ jew (3) jekk id- doża ta ’ ciclosporin hi mnaqqsa sewwa jew imwaqqfa, billi dawn il- popolazzjonijiet huma l- aktar li jkollhom bżonn ta ’ doża speċjali.
Therapeutic drug monitoring should not be the sole basis for adjusting sirolimus therapy.
Il- monitoraġġ tal- mediċina terapewtika m’ għandux ikun l- uniku bażi biex tiġi aġġustata terapija b’ sirolimus.
Careful attention should be made to clinical signs/ symptoms, tissue biopsies, and laboratory parameters.
Għandha tingħata attenzjoni bir- reqqa għal sinjali/ sintomi kliniċi, bijopsiji tat- tessuti, u parametri tal- laboratorju.
To minimise variability, Rapamune should be taken at the same time in relation to ciclosporin, 4 hours after the ciclosporin dose, and consistently either with or without food (see section 5.2).
Sabiex titnaqqas l- inkonsistenza, Rapamune għandu jittieħed fl- istess ħin f’ relazzjoni ma ’ ciclosporin, 4 sigħat wara d- doża ta ’ ciclosporin, u b’ mod konsistenti jew mal- ikel jew fuq stonku vojt (ara sezzjoni 5. 2).
Optimally, adjustments in Rapamune dosage should be based on more than a single trough level obtained > 5 days after a previous dosing change.
Idealment, aġġustamenti fid- doża ta ’ Rapamune għandhom ikunu bbażati fuq iktar minn livell wieħed l- aktar baxx, miksub > 5 ijiem wara bidla fl- iddożar.
Following the discontinuation of ciclosporin therapy, a target trough range of 12 to 20 ng/ ml (chromatographic assay) is recommended.
Wara li titwaqqaf it- terapija ta ’ ciclosporin, hu rakkomandat li tintlaħaq medda ta ’ konċentrazzjoni ta ’ livell l- aktar baxx bejn 12 u 20 ng/ ml (assaġġ kromatografiku).
Ciclosporin inhibits the metabolism of sirolimus, and consequently, sirolimus levels will decrease when ciclosporin is discontinued unless the sirolimus dose is increased.
Ciclosporin jimpedixxi l- metaboliżmu ta ’ sirolimus, u b’ konsegwenza, il- livelli ta ’ sirolimus jonqsu meta ciclosporin jitwaqqaf, sakemm ma tiżdiedx id- doża ta ’ sirolimus.