qanastek/EMEA-V3 huggingface dataset:
For the full list of all side effects reported with Thalidomide Celgene, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rappurtati ma' Thalidomide Celgene, ara l- Fuljett ta 'Tagħrif.
Thalidomide is a powerful human ‘ teratogen’, meaning that it has a harmful effect on the unborn child, causing severe and life-threatening birth defects.
Thalidomide huwa aġent 'teratoġenu' qawwi fil- bniedem, jiġifieri jagħmel il- ħsara lill- feti billi jikkawżalhom difetti gravi u perikolużi mat- twelid.
The strict conditions put in place to prevent pregnancies and the exposure of unborn children to thalidomide must be met by all men and women taking the medicine.
L- irġiel u n- nisa kollha li jieħdu thalidomide għandhom isegwu bir- reqqa l- kundizzjonijiet imfassla għall- prevenzjoni tat- tqala u għall- prevenzjoni tal- esponiment tal- feti għal thalidomide.
Thalidomide Celgene must never be used by the following groups:  women who are pregnant;  women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;  patients who are unable to follow or to comply with the requirement to use contraceptives.
Thalidomide Celgene m' għandu jingħata qatt lil dawn il- gruppi:  nisa tqal;  nisa li jistgħu joħorġu tqal jekk ma jiħdux il- passi kollha meħtieġa biex ikun żgurat li ma humiex tqal qabel it- trattament u li ma joħorġux tqal waqt jew ftit wara t- trattament;  pazjenti li ma jkunux jistgħu jsegwu jew jikkonformaw mar- rekwiżit li jużaw kontraċettivi.
Thalidomide Celgene should also not be used in people who may be hypersensitive (allergic) to thalidomide or any of the other ingredients.
Thalidomide Celgene lanqas ma għandu jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal thalidomide jew għal xi sustanza oħra tiegħu.
Why has Thalidomide Celgene been approved?
Għaliex ġie approvat Thalidomide Celgene?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide Celgene’ s benefits are greater than its risks, in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged greater than or equal to 65 years or ineligible for high dose chemotherapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li, sakemm ikunu implimentati miżuri stretti ħafna biex jipproteġu feti mill- esponiment għal thalidomide, il- benefiċċji ta 'Thalidomide Celgene huma ikbar mir- riskji tiegħu, flimkien ma' melphalan u prednisone bħala l - ewwel linja ta 'trattament ta' pazjenti b' mjeloma multipla mhux ittrattata li jkollhom 65 sena jew iktar jew li jkunu ineliġibbli għal kemjoterapija f' dożi għolja.
The Committee recommended that Thalidomide Celgene be given marketing authorisation.
Il- Kumitat irrakkomanda li Thalidomide Celgene jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Thalidomide Celgene?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Thalidomide Celgene?
The company that makes Thalidomide Celgene will set up a pregnancy prevention programme in each Member State.
Il- kumpanija li tipproduċi Thalidomide Celgene se toħloq programm għall- prevenzjoni tat- tqala f' kull Stat Membru.
It will provide a letter and educational kits for healthcare workers and brochures for 2/ 3 patients, detailing the steps that need to be taken for the medicine to be used safely.
Se tipprovdi ittra u pakketti edukattivi għall- ħaddiema fil- qasam tal- kura tas- saħħa u 2/ 3 opuskoli għall- pazjenti, li fihom jingħataw dettalji tal- passi li jkunu jridu jittieħdu biex il- mediċina tintuża b' mod sigur.
Each Member State will also ensure that educational materials and patient cards are provided as necessary to prescribers and patients.
Se tipprovdi wkoll kards ta 'tagħrif għall- pazjenti biex ikun żgurat li jkunu pprovduti materjali edukattivi u kards tal- pazjent kif meħtieġ għal min jippreskrivi u għall- pazjenti.
The company will also collect information on whether the medicine is used outside its approved indication.
Il- kumpanija se tiġbor ukoll tagħrif dwar jekk il- mediċina tintużax barra l- indikazzjoni approvata tagħha.
The boxes containing Thalidomide Celgene capsules will include a warning stating that thalidomide is harmful to the unborn child.
Il- kaxex bil- kapsuli ta 'Thalidomide Celgene se jkun fihom twissija li tgħid li thalidomide jagħmel il- ħsara lill- feti.
Other information about Thalidomide Celgene:
Informazzjoni oħra dwar Thalidomide Celgene:
The European Commission granted a marketing authorisation valid throughout the European Union for Thalidomide Pharmion on 16 April 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Thalidomide Pharmion fis- 16 ta’ April 2008.
The marketing authorisation holder is Celgene Europe Ltd.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Celgene Europe Ltd.
The name of the medicine was changed to Thalidomide Celgene on 22 October 2008.
Isem il- mediċina nbidlet għal Thalidomide Celgene fit- 22 ta ’ Ottubru 2008.
The summary of opinion of the Committee for Orphan Medicinal Products for Thalidomide Celgene is available here.
Is- sommarju tal- opinjoni tal- Kumitat għal Prodotti Mediċinali Orfni għal Thalidomide Celgene huwa disponibbli hawn.
The full EPAR for Thalidomide Celgene can be found here.
L- EPAR sħiħ għal Thalidomide Celgene jista 'jiġi kkonsultat hawn.
EU number EU/ 1/ 08/ 443/ 001
Numru ta ’ l- EU EU/ 1/ 08/ 443/ 001
Name Thalidomide Celgene
Isem Thalidomide Celgene
Strength 50 mg
Qawwa 50 mg
Pharmaceutical Form Capsule, hard
Għamla Farmaċewtika Kapsula, iebsa
Route of administration Oral use
Mnejn Jingħata Użu orali
Packaging Blister (PVC/ PE/ Aclar/ Alu)
Pakkett Folja (PVC/ PE/ Aclar/ Alu)
Package size 28 capsules
Daqs tal- Pakkett 28 kapsula
Thalidomide Celgene 50 mg hard capsules
Thalidomide Celgene 50 mg kapsuli iebsin.
Each capsule contains 50 mg of thalidomide.
Kull kapsula fiha 50 mg thalidomide.
Each capsule contains 257.2 mg of anhydrous lactose.
Kull kapsula fiha 257. 2 mg ta ’ lactose anhydrous.
White opaque capsules marked “ Thalidomide 50 mg Celgene”.
Kapsuli opaki mmarkati “ Thalidomide 50 mg Celgene ”.
Thalidomide Celgene in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.
Thalidomide Celgene flimkien ma ’ melphalan u prednisone bħala l- ewwel linja ta ’ trattament ta ’ pazjenti b’ majeloma multipla mhux trattata li għandhom ≥ 65 sena jew li m’ humiex eleġibbli għal doża għolja ta ’ kimoterapija.
Thalidomide Celgene is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
Thalidomide Celgene jingħata b’ riċetta u jiġi mogħti skond il- Programm ta ’ Prevenzjoni ta ’ Tqala ta ’ Thalidomide Celgene (ara sezzjoni 4. 4).
Thalidomide treatment must be initiated and monitored under the supervision of physicians with expertise in managing immunomodulatory or chemotherapeutic agents and a full understanding of the risks of thalidomide therapy and monitoring requirements (see section 4.4).
It- trattament b’ thalidomide għandu jinbeda u jkun monitorjat taħt is- superviżjoni ta ’ tabib li għandu kompetenza fil- ġestjoni ta ’ aġenti immunomodulatorji jew kimoterapewtiċi u jifhem bi sħiħ ir- riskji involuti fit- terapija b’ thalidomide u l- ħtiġijiet ta ’ monitoraġġ (ara sezzjoni 4. 4).
Recommended posology in adults:
Il- pożoloġija rrakkomandata għall- adulti:
The recommended oral dose is 200 mg per day.
Id- doża orali rakkomandata hi ta ’ 200 mg kuljum.
A maximum number of 12 cycles of 6 weeks should be used.
Għandu jintuża n- numru massimu ta ’ 12- il ċiklu ta ’ 6 ġimgħat.
Thalidomide Celgene should be taken as a single dose at bedtime, to reduce the impact of somnolence.
Thalidomide Celgene għandu jittieħed bħala doża waħda qabel l- irqad, sabiex jonqos l- effett ta ’ ngħas.
Thalidomide Celgene can be taken with or without food.
Thalidomide Celgene jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Patients should be monitored for: thromboembolic events; peripheral neuropathy; rash/ skin reactions; bradycardia, syncope and somnolence (see sections 4.4 and 4.8).
Il- pazjenti għandhom jiġu monitorati għal: każijiet tromboembolitiċi; newropatija periferali; reazzjonijiet ta ’ raxx/ tal- ġilda; bradikardja, sinkope u ngħas (ara sezzjonijiet 4. 4 u 4. 8).
Dose delay, reduction or discontinuation, dependent upon the NCI CTC grade, may be necessary.
Jista ’ jkun meħtieġ li d- doża tingħata aktar tard, titnaqqas jew titwaqqaf għal kollox skond il- grad ta ’ NCI CTC.
Thromboembolic events:
Każijiet tromboemboliċi:
Thromboprophylaxis should be administered for at least the first 5 months of treatment especially in patients with additional thrombotic risk factors.
It- tromboprofilassi għandha tingħata għal mill- inqas l- ewwel 5 xhur tal- kura speċjalment f’ pazjenti b’ fatturi addizzjonali ta ’ riskju trombotiku.
Prophylactic antithrombotic medicinal products, such as low molecular weight heparins or warfarin, should be recommended.
Prodotti mediċinali antitrombotiċi profilattiċi, bħal eparini ta ’ piż molekulari baxx jew warfarin, għandhom ikunu rakkomandati.
The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient’ s underlying risk factors (see sections 4.4, 4.5 and 4.8).
Id- deċiżjoni biex jittieħdu miżuri profilattiċi antitrombotiċi għandha ssir wara evalwazzjoni bir- reqqa tal- fatturi tar- riskju bażiċi ta ’ pazjent individwali (ara Sezzjonijiet 4. 4, 4. 5 u 4. 8).
If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Jekk pazjent ikollu xi każ tromboemboliku, it- trattament għandu jitwaqqaf u għandha tinbeda t- terapija
2 and any complications of the thromboembolic event have been managed, the thalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment.
Ġaladarba l- pazjent ikun stabilizza ruħu fuq it- trattament ta ’ l- antikoagulazzjoni u kull kumplikazzjoni dwar l- okkorenza tromboembolitika tkun ġiet ikkontrollata, it- trattament b’ thalidomide jista ’ jerġa ’ jibda mill- ġdid fuq id- doża oriġinali wara analiżi dwar il- benefiċċju u r- riskju.
The patient should continue anticoagulation therapy during the course of thalidomide treatment.
Il- pazjent għandu jissokta fuq it- terapija ta ’ antikoagulazzjoni waqt il- kors ta ’ trattament b’ thalidomide.
Dose modifications due to peripheral neuropathy are described in Table 1.
Tabella 1:
Recommended dose modifications for Thalidomide Celgene related neuropathy in first line treatment of multiple myeloma.
Modifikazzjonijiet tad- doża rrakkomandati għal newropatija relatata ma ’ Thalidomide Celgene fl- ewwel linja ta ’ trattament ta ’ myeloma multiplika.
Severity of neuropathy Grade 1 (paraesthesia, weakness and/ or loss of reflexes) with no loss of function
Severità ta ’ newropatija Grad 1 (paraestesija, debulezza u/ jew telf tar- riflessi) mingħajr telf fil- funzjoni
Modification of dose and regimen Continue to monitor the patient with clinical examination.
Modifikazzjoni tad- doża u tar- reġimen Ibqa ’ immonitorja il- pazjent b’ eżami kliniku.
Consider reducing dose if symptoms worsen.
Ikkunsidra tnaqqasx id- doża jekk is- sintomi jiggravaw.
However, dose reduction is not necessarily followed by improvement of symptoms.
Madankollu, it- tnaqqis fid- doża ma jkunx neċessarjament segwit minn titjib fis- sintomi.
Grade 2 (interfering with function but not with activities of daily living)
Grad 2 (li jinterferixxi fil- funzjoni imma mhux f’ attivitajiet tal- ħajja ta ’ kuljum)
If no improvement or continued worsening of the neuropathy, discontinue treatment.
Naqqas id- doża jew waqqaf it- trattament u ibqa ’ immonitorja l- pazjent b ’ eżami kliniku u newroloġiku Jekk ma tarax titjib jew in- newtropatija tibqa ’ sejra għall- agħar, waqqaf it- trattament.
If the neuropathy resolves to Grade 1 or better, the treatment may be restarted, if the benefit/ risk is favourable.
Jekk in- newropatija tirriżolvi ruħha għal Grad 1 jew aħjar it- trattament jista ’ jerġa ’ jibda mill- ġdid jekk l- analiżi tal- benefiċċju/ riskju huwa favorevoli.
Grade 3 (interfering with activities of daily living)
Grad 3 (li jinterferixxi fl- attivitajiet ta ’ kuljum) Grad 4 (newropatija li tiddiżabilita)
Grade 4 (neuropathy which is disabling)
Waqqaf it- trattament Waqqaf it- trattament
No specific dose adjustments are recommended for the elderly.
L- ebda aġġustament speċifiku tad- doża mhu rakkomandat għall- anzjani.
Patients with renal or hepatic impairment:
Pazjenti b’ impediment renali jew epatiku:
Thalidomide Celgene has not formally been studied in patients with impaired renal or hepatic function.
Thalidomide Celgene ma ġiex formalment studjat f’ pazjenti li għandhom il- funzjoni renali jew epatika indebolita.
No specific dose recommendations for these patient populations are available.
M’ hemmx rakkomandazzjonijiet speċifiċi dwar id- doża għal dawn il- popolazzjonijiet ta ’ pazjenti.
Patients with severe organ impairment should be carefully monitored for adverse reactions.
Pazjenti li jbatu minn impediment sever ta 'l- organi għandhom ikunu mmonitorjati bir- reqqa għall- reazzjonijiet avversi.
Thalidomide Celgene is not recommended for use in children below 18 years of age as safety and efficacy have not been established.
Thalidomide Celgene mhux rakkomandat għall- użu fuq tfal li għandhom anqas minn 18- il sena peress li s- sigurtà u l- effikaċja għadhom ma ’ ġewx stabbiliti.
− Hypersensitivity to thalidomide or to any of the excipients. − Pregnant women (see section 4.6). − Women of childbearing potential unless all the conditions of the Thalidomide Celgene Pregnancy Prevention Programme are met (see sections 4.4 and 4.6). − Patients unable to follow or comply with the required contraceptive measures (see section 4.4).
Pazjenti li ma jistgħux isegwu jew jikkonformaw mal- miżuri kontraċettivi meħtieġa − (ara sezzjoni 4. 4).
Teratogenic effects:
Effetti teratoġeniċi:
Thalidomide is a powerful human teratogen, inducing a high frequency of severe and life- threatening birth defects.
Thalidomide huwa teratoġen uman qawwi, li jissensitizza frekwenzi għoljin li jistgħu jkunu ta ’ periklu għal ħajja b ’ mankamenti mit- twelid.
Thalidomide must never be used by women who are pregnant or could become pregnant.
Thalidomide m’ għandu qatt jintuża minn nisa li huma tqal jew li jistgħu jinqabdu tqal.
The conditions of the Thalidomide Celgene Pregnancy Prevention Programme must be fulfilled for all male and female patients.
Il- kundizzjonijiet tal- Programm ta ’ Prevenzjoni ta ’ Tqala ta ’ 3 Thalidomide Celgene għandhom ikunu sodisfatti għal pazjenti kollha nisa u rġiel.
Criteria for women of non-childbearing potential:
Kriterji għal nisa li ma jistax ikollhom tfal:
A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year*. • Premature ovarian failure confirmed by a specialist gynaecologist. • Previous bilateral salpingo-oophorectomy, or hysterectomy. • XY genotype, Turner’ s syndrome, uterine agenesis. *Amenorrhoea following cancer therapy does not rule out childbearing potential.
Pazjenta mara jew partner mara ta ’ pazjent raġel hi kkonsidrata li jista ’ jkollha t- tfal ħlief meta ma tissodisfax ta ’ lanqas wieħed minn dawn il- kriterji: • Età > 50 sena u amenorreika għal > minn sena *. • Ċediment ovarju prematur ikkonfermat minn ginekoloġista. • Salpingo- ooforektomija bilaterali jew isterektomija li saret qabel. • Ġenotip XY, sindromu ta ’ Turner, aġenesi f ’ l- utru. * L- amenorrea wara terapija tal- kanċer ma teskludiex il- possibilità li dik il- persuna jista ’ jkollha t- tfal.
Counselling:
Parir:
For women of childbearing potential, thalidomide is contraindicated unless all of the following are met: • She understands the teratogenic risk to the unborn child • She understands the need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment • Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception • She should be capable of complying with effective contraceptive measures • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy • She understands the need to commence the treatment as soon as thalidomide is dispensed following a negative pregnancy test • She understands the need and accepts to undergo pregnancy testing every 4 weeks • She acknowledges that she understands the hazards and necessary precautions associated with the use of thalidomide.
Għal nisa li jista ’ jkollhom it- tfal, thalidomide huwa kontra- indikat għajr meta l- punti kollha li ġejjin huma sodisfatti: • Hi tifhem ir- riskju teratoġeniku tat- tarbija mhix mwielda • Hi tifhem il- bżonn ta ’ kontraċezzjoni effettiva, mingħajr interruzzjoni, minn 4 ġimgħat qabel ma jinbeda t- trattament tul il- perijodu kollu tat- trattament u għal 4 ġimgħat wara it- tmiem tat- trattament • Anke jekk mara li jista ’ jkollha t- tfal għandha amenorrea din għandha ssegwi r- rakkomandazzjonijiet kollha dwar kontraċezzjoni effettiva • Għandha tkun kapaċi tikkonforma mal- miżuri ta ’ kontraċezzjoni effettiva • Hi informata u tifhem il- konsegwenzi potenzjali dwar tqalat u l- bżonn li tikkonsulta malajr jekk ikun hemm ir- riskju ta ’ tqala • Hi tifhem il- bżonn li tibda tingħata t- trattament b’ thalidomide wara test negattiv tat- tqala • Hi tifhem il- bżonn u taċċetta li jkollha tagħmel test tat- tqala kull 4 ġimgħat • Hi tirrikonoxxi li tifhem il- perikli u l- prekawzjonijiet meħtieġa assoċjati ma ’ l- użu ta ’ thalidomide.
As thalidomide is found in semen, male patients taking thalidomide must meet the following conditions: • Understand the teratogenic risk if engaged in sexual activity with a pregnant woman. • Understand the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception.
Peress li thalidomide jinstab fis- semen, pazjenti rġiel li jieħdu thalidomide għandhom jissodisfaw il- kundizzjonijiet li ġejjin: • Jifhmu r- riskju teratoġeniku jekk ikollhom x’ jaqsmu sesswalment ma ’ mara tqila. • Jifhmu l- bżonn li jużaw kondom jekk ikollhom x’ jaqsmu sesswalment ma ’ mara tqila jew mara li tista ’ toħroġ tqila li ma tużax kontraċettiv effettiv.
The prescriber must ensure that: • The patient complies with the conditions of the Thalidomide Celgene Pregnancy Prevention Programme • The patient confirms that he (she) understand the aforementioned conditions.
It- tabib li jikteb ir- riċetta għandu jiżgura li: • Il- pazjent jikkonforma mal- kundizzjonijiet tal- Programm ta ’ Prevenzjoni ta ’ Tqala ta ’ Thalidomide Celgene • Il- pazjent jikkonferma li hu (hi) jifhem il- kundizzjonijiet msemmija hawn fuq.
Contraception:
Kontraċezzjoni:
Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and during 4 weeks after thalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Nisa li jista ’ jkollhom it- tfal, għandhom jużaw metodu effettiv ta ’ kontraċezzjoni minn 4 ġimgħat qabel, waqt, u għal 4 ġimgħat wara t- terapija b’ thalidomide u anke f’ każ ta ’ interruzzjoni tad- doża kemm- il darba l- pazjenta tikkometti ruħa għal astinenza assoluta u kontinwa kkonfermata kull xahar.
If not established on effective contraception, the patient must be referred preferably to an appropriately trained healthcare professional for contraceptive advice in order that contraception can be initiated.
Dawn li ġejjin jistgħu jkunu kkonsidrati bħala eżempji ta ’ metodi effettivi ta ’ kontraċezzjoni: • Impjant ormonali taħt il- ġilda • Sistema ġo l- utru li tirrilaxxa levonorgestrel (IUS) • Depot Medroxyprogesterone acetate depot • Sterilizzazzjoni tubali • Att sesswali ma ’ partner raġel vażektomizzat biss; il- vażektomija trid tiġi b’ żewġ testijiet negattivi tas- semen
4 The following can be considered to be examples of effective methods of contraception: • Subcutaneous hormonal implant • Levonorgestrel-releasing intrauterine system (IUS) • Medroxyprogesterone acetate depot • Tubal sterilisation • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses • Ovulation inhibitory progesterone-only pills (i. e., desogestrel)
4 • Pilloli tal- progesterone biss li jinpedixxu l- ovulazzjoni (jiġifieri, desogestrel)
Because of the increased risk of venous thromboembolism in patients with multiple myeloma, combined oral contraceptive pills are not recommended (see section 4.5).
Minħabba r- riskju ogħla ta ’ tromboemboliżmu fil- vini f’ pazjenti b’ amjeloma multipla, pilloli kontraċettivi kkombinati orali m’ humiex rakkomandati (ara sezzjoni 4. 5).
If a patient is currently using combined oral contraception the patient should switch to one of the effective method listed above.
Jekk pazjent attwalment qed juża kontraċezzjoni orali kkombinata, l- pazjent għandu jeqleb fuq wieħed mill- mezzi effettivi mniżżla hawn fuq.
The risk of venous thromboembolism continues for 4− 6 weeks after discontinuing combined oral contraception.
Ir- riskju ta ’ tromboemboliżmu venuż jibqa ’ għal 4- 6 ġimgħat wara l- waqfien ta ’ pilloli kontraċettivi kkombinati li jittieħdu mill- ħalq.
Pregnancy testing:
Testijiet tat- tqala:
Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ ml must be performed for women of childbearing potential as outlined below.
Testijiet tat- tqala taħt superviżjoni medika b’ sensittività minima ta ’ 25 mIU/ ml hCG għandhom isiru fuq nisa li jista ’ jkollhom it- tfal kif delinejat hawn isfel.
This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Din ir- regola tgħodd ukoll għal nisa li jistgħu joħorġu tqal li jipprattikaw astinenza assoluta u kontinwa.
Prior to starting treatment A medically supervised pregnancy test should be performed during the consultation, when thalidomide is prescribed or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Qabel il- bidu tat - trattament Test tat- tqala taħt superviżjoni medika għandu jsir waqt il- konsultazzjoni meta thalidomide jiġi preskritt jew fit- tliet t’ ijiem qabel il- viżta għand it- tabib, ġaladarba l- pazjenta tkun ilha tuża kontraċezzjoni effettiva għal ta ’ lanqas 4 ġimgħat.
The test should ensure the patient is not pregnant when she starts treatment with thalidomide.
It- test għandu jiżgura li l- pazjenta mhix tqila meta tibda tieħu t- trattament b’ thalidomide.
Follow-up and end of treatment A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment.
Follow- up u tmiem it- trattament Test tat- tqala taħt superviżjoni medika għandu jiġi ripetut kull 4 ġimgħat li għandu jinkludi wkoll test wara 4 ġimgħat li jkun ntemm it- trattament.
These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Dawn it- testijiet tat- tqala għandhom isiru fil- jum li fihom tingħata r- riċetta jew fi żmien 3 ijiem qabel ma ’ issir il- viżta għand it- tabib.
Men:
Irġiel:
As thalidomide is found in semen, male patients must use condoms during treatment and for 1 week after dose interruption and/ or cessation of treatment if their partner is pregnant or is of childbearing potential not using effective contraception.
Peress li thalidomide jinsab fis- semen, pazjenti rġiel għandhom jużaw il- kondoms waqt it- trattament u sa ġimgħa wara interuzzjoni tad- doża u/ jew waqfien tat- trattament jekk is- sieħba hi tqila jew mara li li tista ’ toħroġ tqila u li mhux qed tuża kontraċezzjoni effettiva.
Prescribing and dispensing restrictions:
Restrizzjonijiet fuq l- għoti bir- riċetta tat- tabib u fuq id- distribuzzjoni:
For women of childbearing potential, prescriptions of Thalidomide Celgene should be limited to 4 weeks of treatment and continuation of treatment requires a new prescription.
Għal nisa li jista ’ jkollhom it- tfal, ir- riċetti ta ’ Thalidomide Celgene għandhom ikunu limitati għal 4 ġimgħat ta ’ kura għal nisa ta ’ li jista ’ jkollhom it- tfal, u t- tkomplija tal- kura teħtieġ riċetta ġdida.
Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Idejalment it- testijiet għat- tqala u l- ħruġ ta ’ riċetta u l- għoti tal- mediċina għandhom isiru fl- istess jum.
Dispensing of thalidomide should occur within a maximum of 7 days of the prescription.
L- għoti ta ’ thalidomide għandu jsir fi żmien 7 t’ ijiem minn mindu ħarġet ir- riċetta.
For all other patients, prescriptions of Thalidomide Celgene should be limited to 12 weeks and continuation of treatment requires a new prescription.
Għal pazjenti l- oħrajn kollha, ir- riċetti ta ’ Thalidomide Celgene għandhom ikunu limitati għal 12- il ġimgħa, u t- tkomplija tal- kura teħtieġ riċetta ġdida.
Additional precautions:
Prekawzjonijiet addizzjonali:
Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Il- pazjenti għandhom jiġu mgħarrfa li qatt m’ għandhom jagħtu dan il- prodott mediċinali lil persuna oħra u sabiex jirritornaw kapsuli mhux użati lil l- ispiżjar tagħhom fi tmiem it- trattament.
Patients should not donate blood or semen during therapy or for 1 week following discontinuation of thalidomide.
Il- pazjenti m’ għandhomx jagħtu demm jew semen waqt it- terapija jew wara ġimgħa mill- waqfien ta ’ thalidomide.
Educational materials:
Materjal edukattiv:
In order to assist patients in avoiding foetal exposure to thalidomide and to provide additional important safety information, the Marketing Authorisation holder will provide educational material to healthcare professionals.
Sabiex jassisti l- pazjenti biex ma jkunx hemm espożizzjoni fetali għal thalidomide, u biex jipprovdi tagħrif addizzjonali importanti dwar is- sigurtà, id- detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jipprovdi materjal edukattiv lill- professjonisti tal- kura tas- saħħa.
The Thalidomide Celgene Pregnancy Prevention Programme reinforces the warnings about the teratogenicity of thalidomide, provides advice on contraception before therapy is
Il- Programm dwar il- Prevenzjoni ta ’ Tqala ta ’ Thalidomide Celgene jirrinforza t- twissijiet dwar it- teratoġeniċità, jagħti parir dwar kontraċezzjoni qabel ma tibda t- terapija, u jipprovdi gwida fuq il- bżonn ta ’ testijiet ta ’ tqala.
Full patient information about the teratogenic risk and the pregnancy prevention measures as specified in the Thalidomide Celgene Pregnancy Prevention Programme should be given by the physician to women of childbearing potential and, as appropriate, to male patients.
Informazzjoni sħiħa lil pazjent dwar ir- riskju teratoġeniku u l- miżuri ta ’ prevenzjoni dwar it- tqala kif speċifikati fil- Programm dwar il- Prevenzjoni ta ’ Tqala ta ’ Thalidomide Celgene għandhom jingħataw mit- tabib lil nisa li jista ’ jkollhom it- tfal u, skond kif jixraq lil pazjenti rġiel.
Deep venous thrombosis and pulmonary embolism:
Trombożi profonda tal- vina u emboliżmu polmonari:
An increased risk of deep venous thrombosis (DVT) and pulmonary embolus (PE) has been reported in patients treated with thalidomide (see section 4.8).
Riskju ogħla ta ’ trombożi profonda fil- vina (DVT) u embolu pulmonari (PE) ġew irrapportati f’ pazjenti
The risk appears to be greatest during the first 5 months of therapy.
Ir- riskju jidher l- akbar fl- ewwel 5 xhur tat- terapija.
Thromboprophylaxis and dosing/ anticoagulation therapy recommendations are provided in section 4.2.
Rakkomandazzjonijiet dwar it- tromboprofilassi u t- terapija tad- dożaġġ/ antikoagulazzjoni huma pprovduti f’ sezzjoni 4. 2.
Previous history of thromboembolic events or concomitant administration of erythropoietic agents or other agents such as hormone replacement therapy, may also increase thrombotic risk in these patients.
Passat preċidenti ta ’ episodji tromboemboliċi jew għoti fl- istess ħin ta ’ aġenti eritropojetiċi jew aġenti oħra bħal terapija li tibdel l- ormoni, għandhom mnejn iżidu r- riskju trombotiku f’ dawn il- pazjenti.
Therefore, these agents should be used with caution in multiple myeloma patients receiving thalidomide with prednisone and melphalan.
Għaldaqstant, dawn l- aġenti għandhom jintużaw bil- kawtela f’ pazjenti li jbagħtu minn mijeloma multiplika u li qed jirċievu thalidomide bi prednisone u melphalan.
Particularly, a haemoglobin concentration above 12g/ dl should lead to discontinuation of erythropoietic agents.
B’ mod partikulari, il- konċentrazzjoni ta ’ l- emoglobina ta ’ iktar minn 12g/ dl għandha twassal għat- twaqqif ta ’ sustanzi eritropojetiċi.
Peripheral neuropathy is a very common, potentially severe, adverse reaction to treatment with thalidomide that may result in irreversible damage (see section 4.8).
Newropatija periferali hija reazzjoni avversa komuni ħafna, potenzjalment severa għal thalidomide li jista ’ jirriżulta fi ħsara irriversibbli (ara sezzjoni 4. 8).
In a phase 3 study, the median time to first neuropathy event was 42.3 weeks.
Matul studju ta ’ fażi 3 il- ħin medju għall- ewwel avveniment newropatiku kien ta ’ 42. 3 ġimgħa.
If the patient experiences peripheral neuropathy, follow the dose and schedule modification instruction provided in section 4.2.
Jekk il- pazjent jesperjenza newropatija periferali, imxi skond l- istruzzjonijiet tal- modifikazzjoni tad- doża u l- iskeda pprovduti f’ sezzjoni 4. 2.
Careful monitoring of patients for symptoms of neuropathy is recommended.
Huwa rrakkomandat il- monitoraġġ bir- reqqa tal- pazjenti għal sintomi ta ’ newropatija.
Symptoms include paraesthesia, dysaesthesia, discomfort, abnormal co-ordination or weakness.
Is- sintomi jinkludu paretesija, disestesija, skomfort, koordinazzjoni annormali u debbolezza.
It is recommended that clinical and neurological examinations are performed in patients prior to starting thalidomide therapy, and that routine monitoring is carried out regularly during treatment.
Huwa rakkomandat li jsiru eżamijiet newroloġiċi kliniċi fuq pazjenti qabel ma ’ tinbeda t- terapija b’ thalidomide, u li monitoraġġ ta ’ rutina jitwettaq regolarment waqt it- trattament.
Medicinal products known to be associated with neuropathy should be used with caution in patients receiving thalidomide (see section 4.5).
Prodotti mediċinali magħrufa li huma assoċjati ma ’ newropatija għandhom jintużaw b’ kawtela minn pazjenti li jirċievu thalidomide (ara sezzjoni 4. 5).
Thalidomide may also potentially aggravate existing neuropathy and should therefore not be used in patients with clinical signs or symptoms of peripheral neuropathy unless the clinical benefits outweigh the risks.
Thalidomide jista ’ ukoll potenzjalment jaggrava newropatija eżistenti u għalhekk m’ għandux jintuża f’ pazjenti b’ sinjali jew sintomi kliniċi ta ’ newropatija periferali għajr meta l- benefiċċji kliniċi jisbqu r- riskji.
Syncope and bradycardia:
Sinkope u bradikcardja:
Patients should be monitored for syncope and bradycardia and dose reduction or discontinuation may be required.
Il- pazjenti għandhom jiġu monitorati għal sinkope u bradikardja u jista ’ jkun meħtieġ li titnaqqas id- doża.
Skin reactions:
Reazzjonijiet tal- Ġilda:
If at anytime the patient experiences a toxic skin reaction e. g.
Jekk fi kwalunkwe ħin il- pazjent jesperjenza reazzjoni tossika tal- ġilda e. g.
Stevens-Johnson Syndrome, the treatment should be discontinued permanently.
Sindromu ta ’ Stevens- Johnson, it- trattament għandu jitwaqqaf permanentament.
Somnolence:
Ngħas:
Thalidomide frequently causes somnolence.
Thalidomide ta ’ spiss jikkawża n- ngħas.
Patients should be instructed to avoid situations where somnolence may be a problem and to seek medical advice before taking other medicinal products known to cause somnolence.
Il- pazjenti għandhom jingħataw istruzzjonijiet biex jevitaw sitwazzjonijiet fejn in- ngħas jista ’ jkun problema u sabiex ifittxu parir mediku qabel jieħdu prodotti mediċinali oħra magħrufa li jikkaġunaw in- ngħas.
Patients should be monitored and dose reduction may be required.
Il- pazjenti għandhom ikunu mmonitorjati u għandu mnejn ikun hemm bżonn ta ’ tnaqqis tad- doża.
Patients should be advised as to the possible impairment of mental and/ or physical abilities required for the performance of hazardous tasks (see section 4.7).
Il- pazjenti għandhom jingħataw parir dwar l- indeboliment possibbli ta ’ kapaċitajiet mentali u/ jew fiżiċi meħtieġa għal xogħlijiet perikolużi (ara sezzjoni 4. 7).
6 Patients with renal or hepatic impairment:
Pażjenti b ’ indeboliment tal- kliewi u tal- fwied:
Patients with severe renal or hepatic impairment should be carefully monitored for adverse effects.
Pazjenti b’ indeboliment sever tal- kliewi jew tal- fwied għandhom ikunu mmonitorjati bir- reqqa għall- effetti avversi.
Lactose intolerance:
Intolleranza għal- lattosju:
The capsules contain lactose.
6 Il- kapsuli fihom il- lattosju.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għal galattosju, id- defiċjenza ta ’ lattosju Lapp, jew assorbiment mhux normali ta ’ glukosju- galattosju m’ għandhomx jieħdu dan il- prodott mediċinali.
Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products metabolized by this enzyme system are unlikely.
Thalidomide huwa substrat ħafif għal isoenżimi ta ’ cytochrome P450 u għalhekk interazzjonijiet klinikament importanti ma ’ prodotti mediċinali metabolizzati b’ din is- sistema enżimatika ta ’ CYP huma improbabbli.
Increase of sedative effects of other medicinal products:
Żieda fl- effetti sedattivi ta ’ prodotti mediċinali oħra:
Thalidomide has sedative properties thus may enhance the sedation induced by anxiolytics, hypnotics, antipsychotics, H1 anti-histamines, opiate derivatives, barbiturates and alcohol.
Thalidomide għandu karatteristiċi sedattivi u għalhekk jista ’ jħarrax l- induzzjoni sedattiva b’ ansjolitiċi, ipnotiċi, antipsikotiċi, H1 anti- ħistamini, derivati ta ’ opijati, barbiturati u alkoħol.
Caution should be used when thalidomide is given in combination with medicinal products that cause drowsiness.
Kawtela għandha tiġi użata meta thalidomide jingħata flimkien ma ’ prodotti mediċinali li jikkaġunaw il- ħedla.
Bradycardic effect:
Effett bradikardijaku:
Due to thalidomide’ s potential to induce bradycardia, caution should be exercised with medicinal products having the same pharmacodynamic effect such as active substances known to induce torsade de pointes, beta blockers or anticholinesterase agents.
Minħabba l- potenzjal ta ’ thalidomide li jinduċi bradikardja, kawtela għandha tiġi eżerċitata bi prodotti mediċinali li għandhom l- istess effett farmakodinamiku bħal sustanzi attivi magħrufa li jikkawżaw torsade de pointes, beta blockers jew aġenti anticholinesterase.
Medicinal products known to cause peripheral neuropathy:
Prodotti mediċinali li huma magħrufa li jikkaġunaw newropatija periferali:
Medicinal products known to be associated with peripheral neuropathy (e. g. vincristine and bortezomib) should be used with caution in patients receiving thalidomide.
Prodotti mediċinali magħrufa li huma assoċjati ma ’ newropatija periferali (eż. vincristine u bortezomib) għandhom jintużaw b’ kawtela fuq pazjenti li qed jirċievu thalidomide.
Thalidomide does not interact with hormonal contraceptives.
Thalidomide m’ għandux effett ma ’ kontraċettivi ormonali.
In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 0.75 mg of ethinyl estradiol were studied.
F’ 10 nisa b’ saħħithom, il- profili farmakokinetiċi ta ’ norethindrone u ethinyl estradiol wara l- għoti ta ’ doża waħda li kien fiha 1. 0 mg ta ’ norethindrone acetate u 0. 75 mg ta ’ ethinyl estradiol ġew studjati.
The results were similar with and without co-administration of thalidomide 200 mg/ day to steady-state levels.
Ir- riżultati kienu simili bi u mingħajr l- amministrazzjoni konġunta ta ’ thalidomide 200 mg/ kuljum f’ livelli ta ’ stat fiss.
However, combined hormonal contraceptives are not recommended due to the increased risk of venous thrombo-embolic disease.
Madankollu, kontraċettivi ormonali kkombinati m’ humiex rakkomandati minħabba ir- riskju ogħla ta ’ mard trombiembolitiku venuż.
Multiple dose administration of 200 mg thalidomide q. d. for 4 days had no effect on the international normalized ratio (INR) in healthy volunteers.
L- għoti ta ’ doża multipla ta ’ 200 mg thalidomide q. d. għal 4 t’ ijiem ma kelliex effett fuq il- proporzjon intenazzjonali normalizzat (INR – international normalized ratio) fuq voluntieri b’ saħħithom.
However, due to the increased risk of thrombosis in cancer patients, and a potentially accelerated metabolism of warfarin with corticosteroids, close monitoring of INR values is advised during thalidomide-prednisone combination treatment as well as during the first weeks after ending these treatments.
Madankollu, minħabba r- riskju ogħla ta ’ trombożi f’ pazjenti milquta bil- kanċer, u metaboliżmu potenzjalment aċċelerat ta ’ warfarina bil- kortikosterojdi, monitoraġġ mill- qrib ta ’ l- INR huwa rakkomandat waqt it- trattament kkombinat b’ thalidomide- prednisone kif ukoll matul l- ewwel ġimgħat wara li jintemmu dawn it- trattamenti.
Thalidomide does not interact with digoxin.
Thalidomide m’ għandux effett fuq digoxin.
In 18 healthy male volunteers, multiple dose administration of 200 mg thalidomide had no apparent effect on the single dose pharmacokinetics of digoxin.
Fi 18- il voluntier raġel b’ saħħithom, l- għoti ta ’ doża multipla ta ’ 200 mg thalidomide ma deherx li kellu effett fuq il- farmakokinetika ta ’ doża waħda ta ’ digoxin.
In addition, single dose administration of 0.5 mg digoxin had no apparent effect on thalidomide pharmacokinetics.
Barraminhekk, l- għoti ta ’ doża waħda ta ’ 0. 5 mg digoxin ma deherx li kellu effett fuq il- farmakokinetika ta ’ thalidomides.
It is not known whether the effect will be different in multiple myeloma patients.
Mhux magħruf jekk l- effett ser ikun differenti f’ pazjenti li jbatu minn myeloma mulitiplika.
Thalidomide Celgene is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the Thalidomide Celgene Pregnancy Prevention Programme are met (see section 4.3)
Thalidomide Celgene huwa kontra- indikat waqt it- tqala u f’ nisa li għad jista ’ jkollhom it- tfal għajr meta l- kundizzjonijiet tal- Programm ta ’ Prevenzjoni ta ’ Tqala ta ’ Thalidomide Celgene huma sodisfatti (ara sezzjoni 4. 3).
Thalidomide is a powerful human teratogen, inducing a high frequency (about 30%) of severe and live-threatening birth defects such as: ectromelia (amelia, phocomelia, hemimelia) of the upper and/ or lower extremities, microtia with abnormality of the external acoustic meatus (blind or absent), middle
Thalidomide huwa teratoġen uman qawwi li jissensitizza frekwenzi għolja (madwar 30%) ta ’ mankamenti severi u ta ’ periklu għal ħajja mit- twelid bħal: ektromelija (amelija, fokomelija, hemimelija) ta ’ l- estremitajiet ta ’ fuq u/ jew ta ’ taħt, mikrotja b’ abnormalità tal- meatus akustiku ta ’ barra
7 and internal ear lesions (less frequent), ocular lesions (anophthalmia, microphthalmia), congenital heart disease, renal abnormalities.
7 (għami jew assenti), leżjonijiet fil- widna tan- nofs jew interna (inqas ta ’ spiss), leżjonijiet okulari (anoftalmja, mikroftalmja), mard konġenitali tal- qalb, abnormalitajiet renali.
Other less frequent abnormalities have also been described.
Abnormalitajiet inqas frekwenti ġew deskritti wkoll.
Women of childbearing potential:
Nisa li jistgħu joħorġu tqal:
Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and during 4 weeks after thalidomide therapy (see section 4.4).
Nisa li jistgħu joħorġu tqal għandhom jużaw metodu effettiv ta ’ kontraċezzjoni għal 4 ġimgħat qabel it- terapija, waqt u għal 4 ġimgħat wara li tintemm it- terapija b’ thalidomide (ara sezzjoni 4. 4).
If pregnancy occurs in a woman treated with thalidomide, treatment must be stopped immediately and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Jekk ikun hemm tqala f’ mara trattata b’ thalidomide, it- trattament għandu jieqaf minnufih u l- pazjenta għandha tiġi riferuta lil tabib speċjalizzat jew b’ esperjenza fit- teratoloġija għal evalwazzjoni u parir.
Male patients with female partners of childbearing potential:
Pazjenti rġiel b’ partners nisa li jistgħu joħorġu tqal:
As thalidomide is found in semen, male patients must use condoms during treatment and for 1 week after dose interruption and/ or cessation of treatment when having sexual intercourse with a pregnant woman or with a woman with childbearing potential who is not using effective contraception.
Peress li thalidomide jinsab fis- semen, pazjenti rġiel għandhom jużaw il- kondoms waqt it- trattament u għal ġimgħa wara kull interruzzjoni mid- doża u/ jew waqfien ta ’ trattament waqt att sesswali ma ’ mara tqila jew ma ’ mara li tista ’ toħroġ tqila li mhux qed tuża kontraċezzjoni effettiva.
If pregnancy occurs in a partner of male patient taking thalidomide, the female partner should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Jekk is- sieħba toħroġ tqila u din tkun is- sieħba ta ’ pazjent li qed jieħu thalidomide, is- sieħba mara għandha tkun riferuta għand tabib li hu speċjalist jew għandu esperjenza f’ teratoloġija għall- evalwazzjoni u parir.
It is unknown whether thalidomide is excreted in human breast milk.
Mhux magħruf jekk thalidomide jiġix eliminat mill- ħalib tas- sider tal- bniedem.
Animal studies have shown excretion of thalidomide in breast milk.
Studji fl- annimali wrew l- eliminazzjoni ta ’ thalidomide fil- ħalib tas- sider.
Therefore breast-feeding should be discontinued during therapy with thalidomide.
Għalhekk it- treddigħ għandu jitwaqqaf waqt it- terapija b’ thalidomide.
No studies on the effects on the ability to drive and use machines have been performed.
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
However thalidomide may cause somnolence and blurred vision (see section 4.8).
Madankollu thalidomide jista ’ jikkawża n- ngħas u l- vista mċajpra (ara sezzjoni 4. 8).
If affected, patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with thalidomide.
Jekk affettwati, l- pazjenti għandhom jingħataw struzzjonijiet biex ma jsuqux, ma jużawx inġenji jew jagħmlu xogħol perikoluż waqt li qed jiġu trattati b’ thalidomide.
Most patients taking thalidomide can be expected to experience adverse reactions.
Il- biċċa l- kbira tal- pazjenti li jkunu qed jieħdu thalidomide huma mistennija li jkollhom reazzjonijiet avversi.
The most commonly observed adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone are: neutropenia, leukopenia, constipation, somnolence, paraesthesia, peripheral neuropathy, anaemia, lymphopenia, thrombocytopenia, dizziness, dysaesthesia, tremor and peripheral oedema.
L- aktar reazzjonijiet avversi komuni osservati assoċjati ma ’ l- użu ta ’ thalidomide f’ kombinazzjoni ma ’ melphalan u prednisone huma: newtropenja, lewkopenja, stitikezza, ngħas, parestesija, newropatija periferali, anemija, limfopenja, tromboċitopenja, stordament, disaestesija, tertir, u edema periferali.
The clinically important adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone or dexamethasone include: deep vein thrombosis and pulmonary embolism, peripheral neuropathy, severe skin reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis, syncope, bradycardia, and dizziness (see sections 4.2, 4.4 and 4.5).
Ir- reazzjonijiet avversi klinikament importanti assoċjati ma ’ l- użu ta ’ thalidomide f’ kombinazzjoni ma ’ melphalan u prednisone jew dexamethasone jinkludu: trombożi profonda fil- vina u emboliżmu pulmonari, newropatija perferali, reazzjonijiet severi tal- ġilda li jinkludu s- Sindromu ta ’ Stevens Johnson u nekrolisi epidermali tossika, sinkope, bradikardja u sturdament (ara sezzjonijiet 4. 2, 4. 4 u 4. 5).
Table 2 contains only the adverse reactions for which a causal relationship with medicinal product treatment could reasonably be established.
Tabella 2 fiha biss reazzjonijiet avversi li għalihom relazzjoni każwali bi trattament bil- prodott mediċinali jista ’ raġonevolment jiġi stabbilit.
Frequencies given are based on the observations during a pivotal comparative clinical study investigating the effect of thalidomide in combination with melphalan and prednisone in previously untreated multiple myeloma patients.
Il- frekwenzi mogħtija huma bbażżati fuq l- osservazzjonijiet waqt studju kliniku prinċipali ta ’ komparazzjoni li stħarreġ l- effett ta ’ thalidomide f’ kombinazzjoni ma ’ melphalan u prednisone f’ pazjenti b’ majeloma multipla li ma kienux ġew trattati qabel.
In addition to the adverse reactions noted in the pivotal study, adverse reactions related to thalidomide in combination with dexamethasone and also those based on post-marketing experience with the medicinal product are provided after Table 2.
Barra mir- reazzjonijiet avversi innotati fl- istudju prinċipali, reazzjonijiet avversi relatati ma ’ thalidomide f’ kombinazzjoni ma ’ dexamethasone u anke dawk ibbażżati fuq esperjenza wara li l- prodott mediċinali tqiegħed fis- suq huma mogħtija f’ Tabella 2.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1000); very rare (< 1/ 10,000, not known (cannot be estimated from the available data)).
Il- frekwenzi huma mfissra kif ġej: komuni ħafna (≥1/ 10): komuni (≥1/ 100 to < 1/ 10); mhux komuni (≥1/ 1000 to < 1/ 100); rari (≥1/ 10. 000 to < 1/ 1000); rari ħafna (< 1/ 10. 000, mhux magħrufa (ma jistax jiġi stmat mit- tagħrif disponibbli)).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Fi ħdan kull grupp ta ’ frekwenza, ir- reazzjonijiet avversi huma ppreżentati b’ mod li dawk l- aktar serji jidhru l- ewwel.
Frequency of adverse reactions with thalidomide in combination with melphalan and prednisone
Frekwenza ta ’ reazzjonijiet avversi b’ thalidomide f’ kombinazzjoni ma ’ melphalan u prednisone.
System Organ Class Cardiac disorders
Klassifikazzjoni tas- Sistema ta ’ l- Organi
Common Cardiac failure Bradycardia
Insuffiċjenza kardijaka Bradikardja
Neutropenia Leukopenia Anaemia Lymphopenia Thrombocytopenia
Newtropenja Lewkopenja Anemja Limfopenija Tromboċitopenja
Nervous system disorders
Koordinazzjoni abnormali
Peripheral neuropathy* Tremor Dizziness Paraesthesia Dysaesthesia Somnolence
Disturbi fis- sistema nervuża
Abnormal coordination
Newropatija periferali * Rogħda Sturdament Paraesteżija Disaestheżija Ngħas
Pulmonary embolism* Interstitial lung disease Bronchopneumopathy Dyspnea
Emboliżmu pulmonari * Mard interstitzjali tal- pulmun Bronkopnewmopatija Dispnea
Vomiting Dry mouth
Remettar Ħalq xott
Skin and subcutaneous tissue disorders
Disturbi tal- ġilda u tat- tessut ta ’ taħtha
Toxic skin eruption Rash Dry skin
Infafet tossiċi tal- ġilda Raxx Ġilda xotta
Infections and infestations Vascular disorders
Infezzjonijiet u infestazzjonijiet
Pneumonia Deep vein thrombosis*
Trombożi profonda tal- vini *
Pyrexia Asthenia Malaise
Deni Astenja Telqa
Psychiatric disorders * - See detailed section below
Disturbi psikkjatriċi * - Ara sezzjoni dettaljata isfel
Confusional state Depression
Stat konfużjonali Diprexxin