qanastek/EMEA-V3 huggingface dataset:
In the principal clinical trial, this combination was associated with a prolongation of the survival time by an average of 18 months.
Fl- istudju kliniku ewlieni, din it- taħlita kienet assoċjata ma 'żmien imtawwal ta' sopravivenza ta ’ madwar 18- il xahar.
To find out more about these medicines, please ask your doctor or read the Package Leaflet that comes with these medicines.
Sabiex tkun taf aktar dwar dawn il- mediċini, jekk jogħġbok għid lit- tabib tiegħek jew aqra l- Fuljett ta ’ Tagħrif li jiġi ma dawn il- mediċini.
BEFORE YOU TAKE THALIDOMIDE CELGENE You will have been given specific instructions by your doctor, p articularly on the effects of thalidomide on unborn babies (outlined in the Thalidomide Celgene Pregnancy Prevention Programme).
QABEL MA TIEĦU THALIDOMIDE CELGENE Inti tkun ingħatajt istruzzjonijiet speċifiċi mit- tabib tiegħek, b’ mod partikolari dwar l- effetti ta ’ thalidomide fuq trabi li għadhom ma twieldux (miġbura fil- qosor fil- Programm ta ’ Prevenzjoni ta ’ Tqala ta ’ Thalidomide Celgene).
You will have been given a patient card or any other relevant document by your doctor.
Suppost li inti ngħatajt kard tal- pazjent jew dokumenti relevanti oħra mit- tabib tiegħek.
Read it carefully and follow the related instructions.
Aqrah bir- reqqa u imxi ma ’ l- istruzzjoni relatati.
28 If you do not fully understand these instructions, please ask your doctor to explain them again before you take thalidomide.
28 b’ Thalidomide Celgene ” u “ Tqala ”.
"What Thalidomide Celgene contains:”).
Tieħux Thalidomide Celgene jekk: • Jekk int tqila jew taħseb li inti tqila jew qed taħseb biex tinqabad tqila, peress li Thalidomide Celgene jista ’ jikkawża difetti tat- twelid u mewt tal- fetu • Jekk tista 'tinqabad tqila imma m’ intiex kapaċi ssegwi l- miżuri ta ’ prevenzjoni ta ’ tqala (miġbura fil- qosor fil- Programm ta ’ Prevenzjoni ta ’ Tqala ta ’ Thalidomide Celgene) • Jekk int (tbati minn sensittività eċċessiva) għal thalidomide jew sustanzi oħra ta ’ Thalidomide Celgene (mniżżla f’ sezzjoni 6 “ X’ fih Thalidomide Celgene: ”)
Do not take Thalidomide Celgene if any of the above applies to you.
Tieħux Thalidomide Celgene jekk xi wieħed minn dawn ta ’ fuq japplika għalik.
If you are not sure, talk to your doctor or pharmacist before taking Thalidomide Celgene.
Jekk m’ intiex ċert/ a, għid lit- tabib jew lill- ispiżjar tiegħek qabek tieħu Thalidomide Celgene.
Take special care with Thalidomide Celgene:
Oqgħod attent ħafna b’ Thalidomide Celgene:
Talk to your doctor before taking this medicine in the following situations:
Tkellem mat- tabib tiegħek qabel tibda tieħu din il- mediċina fis- sitwazzjonijiet li ġejjin:
For all patients taking Thalidomide Celgene Check with your doctor before taking this medicine if: • You are at high risk of a blood clot developing in your veins (deep vein thrombosis) or in your lungs (pulmonary embolism). • You do not understand the contraception advice given to you by your doctor or if you do not feel able to follow this advice. • You have nerve damage, such as numbness, tingling or pain in your hands or feet.
Iċċekkja mat- tabib tiegħek qabel tibda tieħu din il- mediċina jekk: • Inti tinsab f’ riskju għoli li tiżviluppa emboli tad- demm fil- vini (trombożi profonda tad- demm) jew fil- pulmuni tiegħek (emboliżmu pulmonari). • Ma tifhimx ir- rakkomandazzjonijiet dwar il- kontraċezzjoni mogħtija lilek mit- tabib tiegħek jew jekk tħoss li ma tistax issegwi dan il- parir • Għandek problemi fin- nervituri, bħal ngħidu aħna tirżiħ, tħoss tingiż jew uġigħ fl- idejn jew is- saqajn.
For women taking Thalidomide Celgene Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely.
Għan- nisa li jieħdu Thalidomide Celgene Qabel tibda t- trattament, inti għandek tistaqsi lit- tabib tiegħek jekk inti tistax tinqabad tqila, anke jekk dan ikun improbabbli.
If you are able to become pregnant: • Your doctor will make sure that you have pregnancy tests o before treatment o every 4 weeks during treatment o 4 weeks after stopping treatment • You must use one effective method of contraception: o for 4 weeks before starting treatment o during treatment o until 4 weeks after stopping treatment Your doctor will tell you what method of contraception to use.
Jekk inti tista ’ tinqabad tqila: • It- tabib tiegħek ser jagħmel żgur li inti jkollok testijiet tat- tqala o qabel it- tratatment o kull 4 ġimgħat qabel it- trattament o 4 ġimgħat wara li tispiċċa t- trattament • Għandek tuża metodu wieħed effettiv ta ’ kontraċezzjoni: o għal 4 ġimgħat qabel tibda t- trattament o waqt it- trattament o sa 4 ġimgħat wara li twaqqaf it- trattament It- tabib tiegħek ser jgħidlek liema metodu ta ’ kontraċezzjoni għandek tuża.
If you are able to become pregnant, your doctor will record with each prescription that the necessary measures, as outlined above, have been taken and will give you a record of this on your patient card or any other relevant documents.
Jekk inti tista ’ tinqabad tqila, it- tabib tiegħek jista ’ jirrekordja ma ’ kull riċetta li l- miżuri meħtieġa hekk kif ġew spjegati fil- qosor hawn fuq, ikunu twettqu u ser jagħtik storja ta ’ dan fil- kard tal- pazjent jew kwalunkwe dokumenti relevanti oħra.
For men taking Thalidomide Celgene Thalidomide passes into semen.
Għall- irġiel li jieħdu Thalidomide Celgene Thalidomide jgħaddi fis- semen.
Therefore do not have unprotected intercourse. • Pregnancy and any exposure during pregnancy must be avoided.
Mela ara li ma jkollokx x' taqsam sesswalment ma 'xi ħadd mingħajr protezzjoni • It- tqala u kwalunkwe esponiment matul it- tqala jrid jiġi evitat.
Always use a condom: o during treatment o for 1 week after stopping treatment • You must not donate semen: o during treatment o for 1 week after stopping treatment
Dejjem uża kondom: o waqt it- trattament o għal ġimgħa wara li tieqaf mit- trattament • Inti m’ għandekx tagħti semen: o waqt it- trattament o għal ġimgħa wara li tieqaf mit- trattament
Donating Blood:
Għoti tad- demm:
You must not donate blood during Thalidomide Celgene treatment and for 1 week after stopping treatment.
Inti m’ għandekx tagħti d- demm waqt it- trattament b’ Thalidomide Celgene u għal ġimgħa wara li tkun waqaft mit- trattament.
29 If you are not sure if any of the above apply to you, talk to your doctor before taking Thalidomide Celgene.
29 Jekk inti m’ intiex żgur jekk xi wieħed minn dak imsemmi hawn fuq japplikax għalik, kellem lit- tabib tiegħek qabel tieħu Thalidomide Celgene.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines since other medicines could interfere with the effect of thalidomide.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra għax mediċini oħra jistgħu jfixklu l- effett ta ’ thalidomide.
This includes medicines obtained without a prescription, including herbal medicines.
Dan jinkludi mediċini miksuba mingħajr riċetta, li jinkludu mediċini magħmulin mill- ħaxix.
Make sure you tell your doctor if you are taking any medicines which cause sleepiness as thalidomide may increase their effects.
Ara li tgħid lit- tabib tiegħek jekk qed tieħu kwalunkwe mediċina li traqdek għax thalidomide għandu mnejn iżid l- effetti tagħha.
Taking Thalidomide Celgene with food and drink:
Meta tieħu Thalidomide Celgene ma ’ l- ikel u x- xorb:
Thalidomide Celgene can be taken with or without food (see section 3, “How to take Thalidomide Celgene”).
Thalidomide Celgene jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt (ara sezzjoni 3, “ Kif tieħu Thalidomide Celgene ”).
Do not drink alcohol while you are taking Thalidomide Celgene.
M’ għandekx tieħu alkoħol meta qed tieħu Thalidomide Celgene.
This is because alcohol can make you sleepy and Thalidomide Celgene can make you even sleepier.
Dan minħabba li alkoħol jista ’ iħeddlek u Thalidomide Celgene jista ’ jagħmlek aktar bi ngħas.
If you are pregnant, you must not take Thalidomide Celgene.
Thalidomide jikkaġuna mankamenti severi jew mewt fit- tarbija mhix mwielda. • Saħansitra kapsula waħda meħuda minn mara tqila jista ’ jikkaġuna mankamenti serji fuq it- tarbija. • Dawn il- mankamenti jistgħu jinkludu driegħ jew riġlejn mqassra, idejn jew riġlejn malformati u problemi bl- organi interni Jekk inti tqila inti m’ għandekx tieħu Thalidomide Celgene.
In addition, you must not become pregnant while taking Thalidomide Celgene.
Barraminhekk, inti m’ għandekx tinqabad tqila waqt li qed tieħu Thalidomide Celgene.
You must use one effective method of contraception if you are a woman who is able to become pregnant (see section 2, “Take special care with Thalidomide Celgene”).
Għandek tuża metodu effettiv ta ’ kontraċezzjoni jekk inti mara li tista ’ tinqabad tqila (ara sezzjoni 2, “ Oqgħod attenta ħafna b’ Thalidomide Celgene ”).
You must stop treatment and inform your doctor straight away if: • You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant. • You have heterosexual intercourse without using an effective method of contraception.
Għandek twaqqaf it- trattament u tinforma lit- tabib minnufih jekk: • Tqabeż jew taħseb li qbiżt pirjid jew jekk għandek demm menstrwali mhux tas- soltu, jew qed tissuspetta li inti tqila. • Inti jkollok x’ taqsam ma ’ persuna tas- sess oppost mingħajr ma tuża metodu effettiv ta ’ kontraċezzjoni.
If you do become pregnant during the treatment with thalidomide, you must stop the treatment and inform your doctor immediately.
Jekk toħroġ tqila matul it- trattament b’ thalidomide, int trid twaqqaf it- trattament u tavża lit- tabib tiegħek minnufih.
For men taking Thalidomide Celgene who have a female partner who is able to become pregnant, please see section 2 “Take special care with Thalidomide Celgene”.
Għall- irġiel li jieħdu Thalidomide Celgene li għandhom partner mara li tista ’ tinqabad tqila, jekk jogħġbok ara sezzjoni 2 “ Oqgħod attent b’ Thalidomide Celgene ”.
If your partner becomes pregnant whilst you are taking thalidomide, you should inform your doctor immediately.
Jekk is- sieħba tiegħek toħroġ tqila waqt li int qed tieħu thalidomide, int għandek tavża lit- tabib tiegħek minnufih.
Do not breastfeed when taking Thalidomide Celgene as it is not known if thalidomide is passed into human breast milk.
Treddax waqt li tkun qed tieħu Thalidomide Celgene għax mhux magħruf jekk thalidomide jgħaddix fil- ħalib tas- sider uman.
Do not drive or use any tools or machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.
M’ għandekx issuq jew tuża kwalunke għodda jew inġenji jekk tħoss xi effetti kollaterali, bħal stordament, għeja, ngħas jew vista mċajpra.
Important information about some of the ingredients of Thalidomide Celgene:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Thalidomide Celgene:
Thalidomide Celgene contains lactose (a type of sugar).
Thalidomide Celgene fih il- lattosju (tip ta ’ zokkor).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li inti għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE THALIDOMIDE CELGENE
KIF GĦANDEK TIEĦU THALIDOMIDE CELGENE
Always take Thalidomide Celgene exactly as your doctor has told you to.
Dejjem għandek tieħu Thalidomide Celgene skond il- parir tat- tabib.
You should check with your doctor if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jekk ikollok xi dubju.
30 Thalidomide Celgene is not suitable under the age of 18.
30 Thalidomide Celgene mhux tajjeb għal min għandu inqas minn 18.
How much to take:
Kemm għandek tieħu:
The usual dose is 200 mg (4 capsules) a day.
Id- doża normali hija 200 mg (4 kapsuli) kuljum.
However your doctor will choose the dose for you, monitor your progress and may adjust your dose.
Madankollu t- tabib tiegħek ser jagħżillek id- doża, jimmonitorja l- progress tiegħek u għandu mnejn jaġġusta d- doża tiegħek.
Your doctor will tell you how to take Thalidomide Celgene and for how long you will need to take it.
It- tabib tiegħek ser jgħidlek kif tieħu Thalidomide Celgene u għal kemm żmien trid tibqa ’ tieħdu.
Thalidomide Celgene is taken in treatment cycles, each cycle lasting 6 weeks, in combination with melphalan and prednisone which are taken on days 1 to 4 of each 6 week cycle.
Thalidomide Celgene jittieħed fiċ- ċikli ta ’ trattament, kull ċiklu jdum 6 ġimgħat, flimkien ma 'melphalan u prednisone li jittieħdu fil- ġranet 1 sa 4 ta' kull ċiklu ta 'sitt ġimgħat.
Taking this medicine: • Take this medicine by mouth • Swallow the capsules whole with a full glass of water • Do not crush or chew • Take the capsules as a single dose before going to bed.
Kif għandek tieħu din il- mediċina: • Ħu din il- medċina mill- ħalq • Ibla ’ l- kapsula sħiħa b’ tazza mimlija bl- ilma • Tkissirix jew tomgħodha • Ħu l- kapsuli bħala doża waħda qabel tmur fis- sodda.
This will make you less likely to feel sleepy at other times.
Dan jagħmilha anqas probabbli li tħossok bi ngħas f’ ħinijiet oħra.
If you take more Thalidomide Celgene than you should:
Jekk tieħu aktar Thalidomide Celgene milli suppost:
If you take more Thalidomide Celgene than you should, talk to a doctor or go to a hospital straightaway.
Jekk tieħu aktar Thalidomide Celgene milli suppost, kellem lit- tabib tiegħek jew mur l- isptar minnufih.
If possible, take the medicine pack and this leaflet with you.
Jekk hu possibbli, hu l- pakkett tal- mediċina u dan il- fuljett miegħek.
If you forget to take Thalidomide Celgene:
Jekk tinsa tieħu Thalidomide Celgene:
If you forget to take Thalidomide Celgene at your regular time and • less than 12 hours have passed: take your capsule immediately. • more than 12 hours have passed: do not take your capsule.
Jekk tinsa tieħu Thalidomide Celgene, fil- ħin regolari tiegħek u • u għaddew inqas minn 12- il siegħa: ħu l- kapsula tiegħek minnufih. • għaddew aktar minn 12- il siegħa: tiħux il- kapsula tiegħek.
Take your next capsule at the usual time the next day.
Ħu l- kapsula tiegħek li jmiss fil- ħin tas- soltu fil- ġurnata ta ’ wara.
POSSIBLE SIDE EFFECTS Like all medicines, Thalidomide Celgene can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, Thalidomide Celgene jista ’ jkollu effetti kollaterali għalkemm ma jidhrux fuq kulħadd.
The frequency of side effects is classified into the following categories:
Il- frekwenza ta ’ l- effetti sekondarji hi kklasifikata fil- kategorji li ġejjin:
Very common Common Uncommon Rare Very rare
Mhux komuni
In more than 1 in 10 patients In more than 1 in 100 patients, but less than 1 in 10 In more than 1 in 1,000 patients, but less than 1 in 100 In more than 1 in 10,000 patients but less than 1 in 1000 patients In less than 1 in 10,000 patients
F’ aktar minn 1 f’ kull 10, 000 pazjent, iżda f’ anqas minn 1 f’ kull 1000 pazjent
The following side effects may happen with this medicine:
F’ inqas minn 1 f’ kull 10, 000 pazjent
Stop taking Thalidomide Celgene and see a doctor straight away if you notice the following serious side effects – you may need urgent medical treatment: • Severe skin reactions including rashes, which is a common side effect and blistering of the skin and mucosa (Stevens Johnson Syndrome and toxic epidermal necrolysis, which are rare side effects).
Tibqax tieħu Thalidomide Celgene u ara t- tabib minnufih jekk tinduna b’ xi effetti sekondarji li ġejjin – għandek mnejn ikollok bżonn trattament mediku urġenti: • Reazzjonijiet severi tal- ġilda inklużi raxxijiet li huma effett sekondarju komuni u l- ġilda trabbi l- infafet u mukoża (Sindromu ta ’ Stevens Johnson u nekrolożi epidermali tossika, li huma effetti sekondarji rari).
You may have a high temperature (fever) at the same time.
Int għandu mnejn ikollok temperatura għolja (deni) fl- istess ħin.
Tell your doctor straight away if you notice any of the following serious side effects: • Numbness, tingling, abnormal co-ordination or pain in your hands and feet.
31 • Tirżih, tnemnim, koordinazzjoni annormali jew uġigħ fl- idejn u s- saqajn.
This may be due to nerve damage (called ‘peripheral neuropathy’), which is a very common side effect.
Dan jista ’ jkun dovut għal ħsara fin- nervituri (li tissejjaħ newropatija periferali ’), li hu effett sekondarju komuni ħafna.
It may become very severe, painful and disabling.
Dan jista jsir sever ħafna, iweġġa ’ u jikkawża diżabilità.
If you experience such symptoms, speak to your doctor straight away, who may reduce the dose or discontinue the treatment.
Jekk ikollok sintomi bħal dawn, kellem lit- tabib tiegħek immedjatament, billi hu jista 'jnaqqas id- doża jew iwaqqaf il- kura.
This side effect usually happens after you have been taking this medicine for several months but can happen sooner than this.
Dan l- effett sekondarju ġeneralment iseħħ jekk tkun ilek tieħu din il- mediċina għal diversi xhur imma tista ’ tiġri aktar kmieni minn hekk.
It can also happen some time after treatment has stopped.
Din tista ’ isseħħ wkoll wara li jkun waqaf it- trattament.
It may not go away, or may go away slowly. • Sudden pain in your chest or difficulty in breathing.
Jista ’ ma jmurx jew imur bil- mod. • Uġigħ f’ daqqa fis- sider u diffikultà biex tieħu n- nifs.
31 This may be due to blood clots in the artery leading to your lungs (called ‘pulmonary embolism’), which is a common side effect.
Dan jista ’ jkun dovut għal emboli tad- demm fl- arterja li twassal għal pulmun (li tissejjaħ ‘ emboliżmu pulmonari ’), li hu effett sekondarju komuni.
These can happen during treatment, or after treatment has stopped. • Pain or swelling in your legs, especially in your lower leg or calves.
Dan jista ’ jseħħ waqt it- trattment jew wara li t- trattment ikun intemm • Uġigħ jew nefħa f’ riġlejk, speċjalment fil- parti ta ’ isfel ta ’ saqajk jew fil- pexxun.
This may be due to blood clots in the veins of your leg (deep vein thrombosis), which is a common side effect.
Dan jista ’ jkun dovut għal emboli tad- demm fil- vini ta ’ riġlejk (trombożi profonda tal- vina) li huwa effett sekondarju komuni.
These can happen during treatment, or after treatment has stopped.
Din tista ’ sseħħ waqt it- trattament, jew wara li t- tratatment ikun waqaf
Other side effects include:
Effetti sekondarji oħra jinkludu:
Very common • Constipation. • Feeling dizzy. • Sleepiness, feeling tired. • Shaking (tremor). • Swelling of hands and feet. • Numbness and tingling • Low blood cell counts.
Komuni ħafna • Stitikezza. • Tħossok stordut. • Ngħas, tħossok għajjien. • Rogħda (tkexkiex). • Nefħa fl- idejn u fis- saqajn. • Estremitajiet imtarrxa u tingiż • Għadd baxx ta ’ ċelloli fid- demm.
This may mean that you are more likely to develop infections.
Dan għandu mnejn ifisser li x’ aktarx ser tiżviluppa infezzjonijiet.
Your doctor may monitor your blood cell counts during treatment with Thalidomide Celgene.
It- tabib tiegħek għandu mnejn jimmonitorja l- għadd taċ- ċelluli tad- demm tiegħek matul it- trattament b’ Thalidomide Celgene.
Common • Indigestion, feeling sick (nausea), being sick (vomiting), dry mouth. • Rash, dryness of the skin. • Feeling weak, faint or unsteady, lack of energy or strength, low blood pressure. • Fever, feeling generally unwell. • A spinning feeling in your head, making it difficult to stand up and move normally. • Having difficulty in seeing or speaking, which is temporary.
Komuni • Indiġestjoni, tħossok ma tiflaħx (dardir), tħossok marid (remettar), ħalq xott. • Raxx, ġilda xotta. • Tħossok debboli, jaqbdek ħass ħażin jew ma tħossokx sod fuq saqajk, nuqqas ta ’ enerġija jew saħħa, pressjoni baxxa tad- demm. • Deni, tħossok ma tiflaħx. • Rasek qed tħossha ddur madwarek, jagħmilha diffiċli li toqgħod bil- wieqfa u timxi b’ mod normali. • Issibha bi tqila tara jew titkellem, li hi ħaġa temporanja.
This may be due to a clot in an artery in the brain. • Blurred vision. • Shortness of breath, difficulty breathing. • Chest infection (pneumonia), lung disease. • A slow heart rate, heart failure. • Depression, confusion, mood changes, anxiety.
Dan jista 'jkun kaġun ta' emboli fl- arterja fil- moħħ. • Vista mċajpra. • Nifsijiet qosra, diffikultà biex tieħu n- nifs. • Infezzjoni fis- sider (pnewmonja), mard tal- pulmun. • Il- qalb tħabbat bil- mod, insuffiċjenza tal- qalb. • Diprexxin, konfużjoni, bidliet fil- burdata, ansjetà.
Uncommon • Having difficulty seeing or speaking due to bleeding from an artery in the brain. • Feeling dizzy when you stand up. • Inflammation and swelling of the tubes in your lungs (bronchitis). • Inflammation of the cells lining your stomach wall. • A hole in part of your large bowel (colon) which can cause infection.
Mhux komuni • Ikollok diffikultà fuq perijodu qasir ta ’ żmien biex tara jew titkellem minħabba embolu tad- demm fil- moħħ, jew emorraġija f’ arterja fil- moħħ. • Tħossok stordut meta tqum bil- wieqfa. • Infjammazzjoni u nefħa fit- tubi tal- pulmuni tiegħek (bronkite). • Infjammazzjoni taċ- ċelloli li jinsabu fir- riti ta ’ l- istonku. • Toqba f’ parti mill- musrana l- kbira tiegħek (kolon) li tista ’ tikkaġuna infezzjoni.
Additional side effects have been reported after this medicine was marketed.
Effetti sekondarji addizzjonali ġew rapportati wara li din il- mediċina ġiet mpoġġija fis- suq.
These include • very serious skin reaction (toxic epidermal necrolysis) • underactive thyroid (hypothyroidism) • bowel obstruction • sexual dysfunction, for example impotence.
Dawn jinkludu • reazzjoni serja ħafna tal- ġilda (nekrolisi epidermali tossika) • tajrojd li mhux attiv kemm suppost (ipotajrojdiżmu) • l- imsaren jinsaddu • nuqqas ta ’ ħajra sesswali, pereżempju impotenza.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
32 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE THALIDOMIDE CELGENE
KIF TAĦŻEN THALIDOMIDE CELGENE
Keep out of the reach and sight of children and any other person not directly involved in the treatment.
Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal u minn kwalunkwe persuna oħra li mhix involuta direttament fit- trattament.
Do not use after the expiry date stated on the wallet card and the blister after EXP.
Tużax wara d- data ta ’ skadenza li tidher fuq il- kard tal- kartiera u l- folja wara JIS.
32 At the end of your treatment you should return all unused capsules to the pharmacist or doctor.
Fi tmiem it- trattament tiegħek inti trid tirritorna l- kapsuli mhux użati kollha għand l- ispiżjar jew it- tabib.
These measures will prevent misuse.
Dawn il- miżuri ser jimpedixxu l- użu ħażin.
What Thalidomide Celgene contains: • The active substance is thalidomide.
X’ fih Thalidomide Celgene: • Is- sustanza attiva hi thalidomide.
Each capsule contains 50mg of thalidomide. • The other ingredients are anhydrous lactose, microcrystalline cellulose, povidone (K90), stearic acid, colloidal anhydrous silica, and crospovidone (Type A).
Kull kapsula fiha 50mg ta ’ thalidomide • Is- sustanzi l- oħra huma anhydrous lactose, microcrystalline cellulose, povidone (K90), stearic acid, colloidal anhydrous silica, u crospovidone (Tip A).
The capsule shell contains gelatin and titanium dioxide (E171).
Il- qoxra tal- kapsula fiha ġelatina u titanium dioxide (E171).
The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol.
L- inka ta ’ l- istampar hi magħmula minn xellak, black iron oxide (E172) u propylene glycol.
What Thalidomide Celgene looks like and contents of the pack:
Id- dehra ta ’ Thalidomide Celgene u d- daqs tal- pakkett:
Thalidomide Celgene are white hard capsules marked “Thalidomide 50 mg Celgene”.
Thalidomide Celgene huma kapsuli bojod iebsa mmarkati “ Thalidomide 50 mg Celgene ”.
The capsules are supplied in a wallet card containing 28 capsules (2 blisters of 14 capsules each).
Il- kapsuli jiġu f’ kards tal- kartiera li fihom 28 kapsula (2 folji ta ’ 14- il kapsula kull waħda).
Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom.
Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, Renju Unit.
Penn Pharmaceuticals Ltd, Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, United Kingdom.
Penn Pharmaceuticals Ltd, Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, Renju Unit.
This leaflet was last approved in {MM/YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq is- sit ta ’ l- internet ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA): http: // www. emea. europa. eu.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għal siti ta ’ l- internet oħra dwar mard rari u kura.
EU number
Mnejn jingħata
Invented name
Daqs tal -
Strength
l- EMEA
100 mg 100 mg 100 mg 100 mg 100 mg
100mg 100mg 100mg 100mg 100mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita
Oral use Oral use Oral use Oral use Oral use
għal użu orali għal użu orali għal użu orali għal użu orali għal użu orali
blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) bottle (HDPE)
folji (PVC/ Aclar/ alu) folji (PVC/ Aclar/ alu) folji (PVC/ Aclar/ alu) folji (PVC/ Aclar/ alu) folji (HDPE)
14 tablets 28 tablets 56 tablets 84 tablets 28 tablets
14- il pilloli 28 pilloli 56 pilloli 84 pilloli 28 pilloli
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 TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GHANDĦOM JIĠU IMPLIMENTATI MILL - ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GHANDĦOM JIĠU INDIRIZZATI LILL- ISTATI MEMBRI
The EU Member States shall ensure that:
L- Istati membri tal- EU għandhom jassiguraw li:
The MAH shall set up a surveillance programme to collect information on: the demographics of patients prescribed Thelin, any adverse reactions and reasons for discontinuation of Thelin.
L- MAH għandu jwaqqaf programm ta ’ sorveljanza biex jiġbor tagħrif dwar: id- demografija tal - pazjenti li jingħataw Thelin, kwalunkwe reazzjonijiet avversi u raġunijiet li minħabba fihom Thelin ma jibqax jingħata.
Details of such a surveillance programme should be agreed with the National Competent Authorities in each member state and put in place prior to marketing of the product.
Id- dettalji dwar programm ta ’ sorveljanza bħal dan għandhom ikunu miftiehma ma ’ l- Awtoritajiet Kompetenti Nazzjonali f’ kull Stat Membru u jkunu implimentati qabel ma l- prodott jitpoġġa fuq is- suq.
The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the following: • Product information • Physician information about Thelin • Patient information card • Partner of patient information card
• Tagħrif dwar il- prodott • Tagħrif għat- tobba dwar Thelin • Karta ta ’ tagħrif għall- pazjent • Karta ta ’ tagħrif għas- sieħeb/ a tal- pazjent/ a
The physician information about Thelin should contain the following key elements: • That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
• Li Thelin hu teratoġeniku o L- użu ta ’ kontraċezzjoni effettiva għan- nisa li qegħdin fl- età li jista ’ jkollhom it- tfal o Interazzjoni possibbli ma ’ kontraċettivi orali u żieda fir- riskju ta ’ tromboemboliżmu o Il- ħtieġa li pazjenti nisa jkunu avżati dwar it- teratoġeniċità, il- kontraċezzjoni, u jekk meħtieġ, il- bżonn li jsir test tat- tqala u x’ għandhom jagħmlu jekk joħorġu tqal o Riferiment ta ’ pazjenti li jinqabdu tqal lil tabib li jkun speċjalizzat jew li għandu esperjenza fit- teratoloġija u d- dijanjosi tagħha, għal evalwazzjoni u pariri
• That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class A- C). o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN): > 3 and ≤ 5 × ULN:
• Li Thelin hu epatotossiku o Il- ħtieġa ta ’ testijiet tal- funzjoni tal- fwied qabel u waqt il- kura o Kontra- indikazzjoni f’ pazjenti li kellhom indeboliment tal- fwied li kien jeżisti minn qabel (Child- Pugh Class A- C). o Il- ħtieġa ta ’ monitoraġġ mill- qrib jekk il- kejl ta ’ l- enzimi tal- fwied ikun > 3 x il- limitu normali ta ’ fuq (ULN): • > 3 u ≤5 × ULN:
Confirm by another liver test within 2 weeks.
Ikkonferma billi tagħmel test ieħor tal- fwied fi żmien ġimagħtejn.
If confirmed, continue to monitor aminotransferases at least every 2 weeks.
Jekk jiġi kkonfermat, kompli segwi l- livell ta ’ l- aminotransferase ta ’ l- inqas kull ġimagħtejn.
If the aminotransferase levels return to pre-treatment values, return to monthly liver testing. > 5 and ≤ 8 × ULN:
Jekk il- livelli ta ’ aminotransferases jerġgħu lura għall- valuri ta ’ qabel bdiet il- kura, erġa mur lura għat- testijiet tal- fwied ta ’ kull xahar. • > 5 u ≤ 8 x ULN:
Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Ikkonferma billi tagħmel test ieħor tal- fwied; jekk dan ikun ikkonfermat, waqqaf il- kura u segwi l- livelli ta ’ aminotransferases ta ’ l- inqas kull ġimagħtejn sakemm il- livelli jiġu għan- normal.
If the aminotransferase levels return to pre-treatment values, reintroducing Thelin may be considered. > 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
Jekk il- livelli ta ’ aminotransferases jerġgħu lura għall- valuri ta ’ qabel bdiet il- kura, ikkunsidra li terġa ’ tintroduċi Thelin skond il- kundizzjonijiet deskritti hawn taħt. • > 8 x ULN:
• That treatment with Thelin often causes a decrease in haemoglobin and related red cell parameters o Need for full blood count prior to use and monitoring at clinically appropriate intervals
• Il- kura b’ Thelin sikwit tikkawża tnaqqis fl- emoglobina u fil- parametri marbuta maċ- ċelluli tad- demm il- ħomor o Il- ħtieġa ta ’ għadd sħiħ tad- demm qabel l- użu u tal- monitoraġġ f’ intervalli adattati klinikament
• Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium o Need for regular monitoring of INR o Be aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
2 • L- effett ta ’ Thelin fuq il- ħruġ tad- demm o Interazzjoni ma ’ warfarin u antagonisti ta ’ vitamina K li jwasslu għal żieda fl- INR o Il- ħtieġa li tnaqqas id- doża stabbilita ta ’ l- antagonisti ta ’ vitamina K meta tibda t - terapija b’ sitaxentan o Ibda l- kura bl- antagonisti ta ’ vitamina K b’ doża mnaqqsa jekk diġà qed jingħata sitaxentan sodium o Il- ħtieġa ta ’ monitoraġġ regolari ta ’ l- INR o Kun af dwar il- potenzjal ta ’ emorraġija u investiga kif suppost o Żieda fir- riskju li tinfaraġ u ħruġ ta ’ demm ġinġivali
2 • That there is an interaction with ciclosporin A which may lead to higher blood concentration of Thelin and hence an increased risk of adverse reactions.
• Li hemm interazzjoni ma ’ ciclosporin A li tista ’ twassal għal konċentrazzjoni ogħla ta ’ Thelin fid- demm u għaldaqstant riskju akbar ta ’ reazzjonijiet avversi.
• That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse drug reactions (ADRs).
• Li d- database tas- sigurtà ta ’ Thelin hi limitata u li t- tobba huma mħeġġa biex jirreġistraw il - pazjenti fil- programm ta ’ sorveljanza biex jiżdied l- għarfien dwar l- inċidenza ta ’ reazzjonijiet avversi importanti tal- mediċina (ADRs - adverse drug reactions).
The surveillance programme should prompt doctors to report serious ADRs and certain selected ADRs as below immediately and other non-serious ADRs at three monthly intervals.
Il- programm ta ’ sorveljanza għandu jħeġġeġ lit- tobba biex jirrappurtaw ADRs serji u ċerti ADRs magħżula bħal dawn t’ hawn taħt, immedjatament u ADRs oħrajn li mhumiex serji, f’ intervalli ta ’ tliet xhur.
The information collected should include: o Anonymised patient details – age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC.
It- tagħrif miġbur għandu jinkludi: o Dettalji anonimi tal- pazjent – età, sess u etoloġija tal- PAH o Mediċini li jittieħdu fl- istess ħin o Raġuni dwar għaliex Thelin m’ għadux jingħata o ADRs ○ L- ADRs serji kollha ○ Żieda fl- enzimi tal- fwied sa > 3 x ULN ○ Anemija ○ Emorraġija ○ Tqala u r- riżultat ○ Edema pulmonari (assoċjata ma ’ mard okklużiv tal- vini) ○ Interrazzjonijiet issuspettati ○ ADRs mhux mistennija skond l- SPC.
The Patient information card should include the following information • That Thelin is teratogenic • The need to ensure that women of child bearing age are using effective contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant. • That Thelin is hepatotoxic and they will need to attend for regular blood tests • The need to tell their doctor about any adverse events • The need to tell their doctor that they are taking Thelin
Il- karta ta ’ tagħrif għall- pazjent għandu jkun fiha t- tagħrif li ġej • Li Thelin hu teratoġinku • Il- ħtieġa biex jiġi żgurat li nisa li qegħdin fl- età li jista ’ jkollhom it- tfal ikunu qed jużaw kontraċezzjoni effettiva u li l- pazjenti għandhom jinfurmaw lit- tobba tagħhom dwar kwalunkwe possibbiltà ta ’ tqala qabel ma tinħareġ riċetta ġdida • Il- ħtieġa li l- pazjenti nisa jikkuntattjaw lit- tabib li jkun qed jikkurahom minnufih jekk jissuspettaw li nqabdu tqal • Li Thelin hu epatotossiku u li jkun meħtieġ li huma jkollhom testijiet tad- demm regolari • Il- ħtieġa li jgħidu lit- tabib tagħhom dwar kwalunkwe avvenimenti avversi • Il- ħtieġa li jgħidu lit- tabib tagħhom li huma qed jieħdu Thelin
Partner of patient information card should include the following information: • That Thelin is teratogenic and that women of child bearing age must use effective contraception
Il- karta ta ’ tagħrif għas- sieħeb/ a tal- pazjent/ a għandu jkun fiha t- tagħrif li ġej • Li Thelin hu teratoġeniku u li nisa li qegħdin fl- età li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni effettiva
Thelin 100 mg film-coated tablets
Thelin 100 mg pilloli miksija b’ rita
Each film-coated tablet contains 100 mg sitaxentan sodium.
Kull pillola miksija b’ rita fiha 100 mg ta ’ sitaxentan sodium.
Also contains 166.3mg of lactose monohydrate.
Fiha wkoll 166. 3 mg ta ’ lactose monohydrate.
Film-coated tablet Capsule shaped yellow-to-orange film-coated tablets, debossed with T-100 on one side.
Pillola miksija b’ rita Pilloli miksija b’ rita, f’ forma ta ’ kapsuli, ta ’ lewn safrani jagħti fl- oranġjo, b’ T- 100 imnaqqxa fuq naħa waħda.
Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity.
Għal kura ta ’ pazjenti li jbatu minn pressjoni għolja fl- arterji pulmonari (PAH) kklassifikata bħala ta ’ kategorija funzjonali III mill- Organizzazzjoni Dinjija tas- Saħħa (WHO), sabiex tittejjeb il- kapaċità ta ’ l- eżerċizzju.
Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
L- effiċjenza ntweriet fi pressjoni għolja pulmonari primarja u fi pressjoni għolja pulmonari assoċjata ma ’ mard tat- tessut konnettiv.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Il- kura għandha tinbeda biss u tiġi ssorveljata minn tabib li għandu esperjenza fil- kura ta ’ PAH.
Thelin is to be taken orally as a dose of 100 mg once daily.
Thelin għandu jittieħed mill- ħalq f’ doża ta ’ 100 mg darba kuljum.
It may be taken with or without food and without regard to the time of day.
Jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt mingħajr ma jingħata kas tal- ħin tal- ġurnata.
In the case of clinical deterioration despite Thelin treatment for at least 12 weeks, alternative therapies should be considered.
F’ każ ta ’ deterjorament kliniku minkejja l- kura b’ Thelin għal mill- inqas 12- il ġimgħa, terapiji alternattivi għandhom jiġu kkunsidrati.
However, a number of patients who showed no response by week 12 of treatment with Thelin responded favourably by week 24, so an additional 12 weeks of treatment may be considered.
Madankollu, għadd ta ’ pazjenti li ma wrewx reazzjoni sa ġimgħa numru 12 tal- kura b’ Thelin irreaġixxew b’ mod favorevoli sa ġimgħa numru 24, u għalhekk 12- il ġimgħa oħra ta ’ kura addizzjonali jistgħu jiġu kkunsidrati.
Higher doses did not confer additional benefit sufficient to offset the increased risk of adverse reactions, particularly liver injury (see section 4.4).
Dożi aktar għoljin ma kienux ta ’ benefiċċju addizzjonali biżżejjed biex ipattu għar- riskju ogħla ta ’ reazzjonijiet avversi, b’ mod partikolari l- ħsara fil- fwied (ara taqsima 4. 4).
Discontinuation of treatment There is limited experience with abrupt discontinuation of sitaxentan sodium.
Twaqqif tal- kura Hemm esperjenza limitata dwar il- waqfien f’ daqqa ta ’ sitaxentan sodium.
No evidence for acute rebound has been observed.
L- ebda evidenza ta ’ rebound akuta ma ġiet osservata.
Studies in patients with pre-existing liver impairment have not been conducted.
Dożaġġ f’ każ ta ’ indeboliment tal- fwied Għadhom ma sarux studji fuq pazjenti li minn qabel il- bidu tal- kura kienu jbatu b’ indeboliment tal - fwied.
Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x Upper Limit of Normal (ULN)) (see section 4.3).
Thelin huwa kontra- indikat f’ pazjenti li diġà ikollhom l- aminotransferases tal- fwied għoljin qabel ma nbdiet il- kura (> 3 x l- Limitu ta ’ Fuq tan- Normal (ULN – Upper Limit of Normal) (ara taqsima 4. 3).
No dose adjustment is required in patients with renal impairment.
2 Dożaġġ f’ każ ta ’ indeboliment tal- kliewi L- ebda aġġustament tad- doża mhu meħtieġ f’ pazjenti b’ indeboliment tal- kliewi.
2 Use in children and adolescents (< 18 years).
Użu fit- tfal u l- adoloxxenti (< 18 years).
Thelin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Thelin mhuwiex rakkomandat biex jingħata lit- tfal u l- adoloxxenti ta ’ taħt it- 18- il sena minħabba n - nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
No dosage adjustment is needed in patients over the age of 65 years.
L- ebda bidla fid- doża mhi meħtieġa f’ pazjenti li għandhom aktar minn 65 sena.
Use in patients using other medicines:
Użu f’ pazjenti li qegħdin jużaw mediċini oħrajn:
The efficacy and safety of Thelin co-administration with other treatments for PAH (eg, epoprostenol, sildenafil, iloprost) has not been studied in controlled clinical trials.
L- effikaċja u s- sigurtà tat- teħid ta ’ Thelin flimkien ma ’ kuri oħrajn għall- PAH (eż. epoprostenol, sildenafil, iloprost) għadhom ma ġewx studjati fi provi kliniċi kkontrollati.
Therefore, caution is recommended in case of co-administration.
Għalhekk, huwa rrakkomandat li wieħed joqgħod attent f’ każ li Thelin ikun qed jingħata flimkien ma ’ kuri oħra.
Hypersensitivity to the active substance or to any of the excipients.
Is- sensittività eċċessiva għas- sustanza attiva jew għal xi waħda mis- sustanzi mhux attivi.
Mild to severe hepatic impairment (Child-Pugh Class A-C).
Indeboliment tal- fwied minn ħafif sa serju (Child- Pugh Klassi A- Ċ).
Elevated aminotransferases prior to initiation of treatment (aspartate aminotransferase (AST) and/ or alanine aminotransferase (ALT) > 3 x ULN).
Aminotransferases għoljin qabel il- bidu tal- kura (aspartate aminotransferase (AST) u/ jew alanine aminotransferase (ALT) > 3 x ULN).
Lactation (see section 4.6).
Teħid konkomitanti ma ’ ciclosporin A (ara taqsima 4. 5).
The efficacy of Thelin as monotherapy has not been established in patients with NYHA/ WHO functional class IV PAH.
L- effikaċja ta ’ Thelin bħala monoterapija għadha ma ġietx stabbilita f’ pazjenti bi PAH ta ’ klassi funzjonali IV tan- NYHA/ WHO.
Transfer to a therapy that is recommended at the severe stage of the disease (eg, epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
It- trasferiment għat- terapija li hi rrakkomandata fl- istadju serju tal - marda (eż. epoprostenol) għandu jiġi kkunsidrat jekk il- kundizzjoni klinika tmur għall- agħar (ara taqsima 4. 2).
Liver function abnormalities have been associated with PAH.
Anormalitajiet tal- funzjoni tal- fwied ġew assoċjati ma ’ PAH.
Endothelin receptor antagonists, as a class, have been associated with liver function abnormalities.
Bħala kategorija, antagonisti tar- riċettur endothelin, ġew assoċjati ma ’ anormalitajiet tal- funzjoni tal- fwied.
Elevations of AST and/ or ALT associated with Thelin occur both early and late in treatment, usually progress slowly, and are typically asymptomatic.
Elevazzjonijiet ta ’ l- AST u/ jew ALT assoċjati ma ’ Thelin, iseħħu kemm fil- bidu kif ukoll fl- aħħar tal - kura, ġeneralment jiżviluppaw bil- mod, u ġeneralment huma mingħajr sintomi.
During clinical trials, these changes were usually reversible when monitoring and discontinuation guidelines were followed.
Waqt provi kliniċi, dawn il- bidliet kienu jerġgħu jiġu lura għan- normal meta l- linji gwida tal- monitoraġġ u tal- waqfien ġew seġwiti.
Liver aminotransferase elevations may reverse spontaneously while continuing treatment with sitaxentan sodium.
Elevazzjonijiet ta ’ aminotransferases tal- fwied jistgħu jitranġaw spontanjament waqt il - kontinwazzjoni tal- kura b’ sitaxentan sodium.
Because treatment-associated elevations of AST and/ or ALT are a marker for potential serious liver injury, liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals.
Minħabba li elevazzjonijiet ta ’ l- AST u/ jew ALT assoċjati mal- kura huma sinjal għal potenzjal ta ’ ħsara serja fil- fwied, il- livelli ta ’ aminotransferases tal- fwied għandhom jiġu mkejla qabel il- bidu tal - kura u sussegwentement f’ intervalli ta ’ kull xahar.
If AST and/ or ALT are > 3 x ULN prior to initiation of therapy, use of Thelin is contraindicated (see section 4.3).
Jekk l- AST u/ jew ALT ikunu > 3 x ULN qabel ma tinbeda l- kura, l- użu ta ’ Thelin huwa kontra- indikat (ara taqsima 4. 3).
The mechanism of liver toxicity is not fully documented and it might vary between endothelin antagonists.
Il- mekkaniżmu ta ’ tossiċita ’ għadu mhux dokumentat biżżejjed, u jista ’ jvarja bejn antagonisti endoteljali.
Appropriate care should be exercised when initiating Sitaxentan in patients who discontinued other endothelin receptor antagonists due to liver enzyme abnormalities (see section 4.8).
Kura adattata għandha tingħata meta jinbeda Sitaxentan f’ pazjenti li waqqfu antagonisti oħra tar- riċetturi ta ’ endothelin, minħabba bdil mhux normali fl- enzimi tal- fwied (ara sezzjoni 4. 8).
Recommendations in case of treatment-emergent ALT/ AST elevations:
Rakkomandazzjonijiet f’ każ li jogħla l- livell ta ’ l- ALT/ AST waqt il- kura:
If ALT/ AST measurements rise to the following levels then changes to the monitoring or treatment are given
Jekk il- kejl ta ’ l- ALT/ AST jogħla għal dawn il- livelli li ġejjin, allura bidliet fil- monitoraġġ u fil- kura jingħataw
3 > 3 and ≤  5 x ULN:
3 > 3 u ≤5 x ULN:
If the aminotransferase levels return to pre-treatment values, return to monthly liver testing.
Jekk il- livelli ta ’ aminotransferases jerġgħu lura għall- valuri ta ’ qabel bdiet il- kura, erġa mur lura għat- testijiet tal- fwied ta ’ kull xahar.
> 5 and ≤ 8 x ULN:
> 5 u ≤8 x ULN:
Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Ikkonferma billi tagħmel test ieħor tal- fwied; jekk dan ikun ikkonfermat, waqqaf il - kura u segwi l- livelli ta ’ aminotransferases ta ’ l- inqas kull ġimagħtejn sakemm il- livelli jiġu għan - normal.
If the aminotransferase levels return to pre-treatment values, consider reintroducing Thelin according to the conditions described below.
Jekk il- livelli ta ’ aminotransferases jerġgħu lura għall- valuri ta ’ qabel bdiet il- kura, ikkunsidra li terġa ’ tintroduċi Thelin skond il- kundizzjonijiet deskritti hawn taħt.
> 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
It- trattament għandu jitwaqqaf u m’ għandux ikun kkunsidrat li jerġa jinbeda Thelin.
If liver transferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, anorexia, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in total bilirubin > 2x ULN, treatment should be stopped and re-introduction of Thelin is not to be considered.
Jekk elevazzjonijiet tat- transferases tal- fwied huma akkompanjati b’ sintomi kliniċi ta ’ ħsara fil- fwied (bħal dardir, rimettar, anoressja, deni, uġigħ ta ’ żaqq, suffejra, jew letarġija jew għeja mhux tas- soltu) u żieda fil- bilirubina totali ta ’ > 2x ULN, il- kura għandha titwaqqaf u l- introduzzjoni mill- ġdid ta ’ Thelin m’ għandhiex tkun ikkunsidrata.
Re-introduction of treatment:
Introduzzjoni mill- ġdid tal- kura:
Re-introduction of treatment with Thelin should only be considered if the potential benefits of treatment with Thelin outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Introduzzjoni mill- ġdid tal- kura b’ Thelin għandha tiġi kkunsidrata biss jekk il- benefiċċji potenzjali tal - kura b’ Thelin ikunu akbar mir- riskji potenzjali u meta l- livelli ta ’ l- aminotransferases tal- fwied ikunu fil- valuri ta ’ qabel inbdiet il- kura.
The advice of a hepatologist is recommended.
Il- parir ta ’ epatoloġista huwa rrakkomandat.
Re-introduction must follow the guidelines detailed in section 4.2.
L- introduzzjoni mill - ġdid trid timxi mal- linji gwida spjegati f’ taqsima 4. 2.
Aminotransferase levels must then be checked within 3 days after re-introduction, then again after a further 2 weeks, and thereafter according to the recommendations above.
Il- livelli ta ’ l- aminotransferase imbagħad għandhom jiġu ċċekkjati fi żmien 3 t’ ijiem wara l- introduzzjoni mill- ġdid, imbagħad wara ġimagħtejn oħra, u mbagħad skond ir- rakkomandazzjonijiet t’ hawn fuq.
Pre-existing liver impairment Studies in patients with pre-existing liver impairment have not been conducted.
Indeboliment pre- eżistenti tal- fwied Studji f’ pazjenti b’ indeboliment tal- fwied diġà eżistenti għadhom ma sarux.
Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x ULN, see section 4.3).
Thelin huwa kontra - indikat f’ pazjenti b’ livelli għoljin ta ’ l- aminotransferases tal- fwied qabel ma tkun inbdiet il- kura (> 3 x ULN, ara taqsima 4. 3).