qanastek/EMEA-V3 huggingface dataset:
In addition to the adverse reactions outlined above thalidomide in combination with dexamethasone in other clinical studies led to the very common adverse reaction of fatigue; common adverse reactions of transient ischaemic event, syncope, vertigo, hypotension, mood altered, anxiety, blurred vision, nausea and dyspepsia; and uncommon adverse reactions of cerebrovascular accident, diverticular perforation, peritonitis, orthostatic hypotension and bronchitis.
Barra mir- reazzjonijiet avversi mogħtija fil- qosor hawn fuq, fi studji kliniċi oħra ta ’ thalidomide flimkien ma ’ dexamethasone ikkaġuna għeja bħala reazzjoni avversa komuni ħafna; reazzjonijiet komuni avversi ta ’ iskemija għaddiena, sinkope, vertiġini, pressjoni baxxa, tibdil fil- burdata, ansjetà, vista mċajpra, dardir u dispepsja; u reazzjoniiet avversi mhux komuni ta ’ aċċident ċerebrovaskulari, perforazzjoni divertikulari, peritonite, pressjoni ortostatika baxxa u bronkite.
Additional adverse reactions related to post-marketing experience with thalidomide and not seen in the pivotal study include: toxic epidermal necrolysis, intestinal obstruction, hypothyroidism and sexual dysfunction.
Reazzjonijiet avversi addizzjonali relatati wara l- esperjenza tat- tqegħid fis- suq ta ’ thalidomide u li ma dehrux fl- istudju prinċipali jinkludu: nekrolisi epidermali tossika, sadd intestinali, ipotajrojdiżmu u nuqqas ta ’ tqanqil sesswali.
Adverse reactions for haematological disorders are provided compared to the comparator arm, as the comparator has a significant effect on these disorders (Table 3)
Rejazzjonijiet avversi għal disturbi ematoloġiċi huma provduti mqabbla mad- driegħ komparatur peress li l- komparatur għandu effett sinjifikanti fuq dawn id- disturbi (Tabella 3)
Comparison of haematological disorders for the melphalan, prednisone (MP) and melphalan, prednisone, thalidomide (MPT) combinations in study IFM 99-06 (see section 5.1)
Tqabbil bejn id- disturbi ematoloġiċi għal kombinazzjonijiet ta ’ melphalan, prednisone (MP) u melphalan, prednisone, thalidomide (MPT) fl- istudju IFM 99- 06 (ara sezzjoni 5. 1)
n (% of patients)
n (% ta ’ pazjenti)
MP (n=193) Grades 3 and 4*
MP (n=193) 9 Gradi 3 u 4 *
Neutropenia Leukopenia Anaemia Lymphopenia Thrombocytopenia * WHO Criteria
Newtropenja Lewkopenja Anemija Limfopenja Tromboċitopenja * Kriterji WHO
57 (29.5) 32 (16.6) 28 (14.5) 14 (7.3) 19 (9.8)
57 (29. 5) 32 (16. 6) 28 (14. 5) 14 (7. 3) 19 (9. 8)
53 (42.7) 32 (25.8) 17 (13.7) 15 (12.1) 14 (11.3)
53 (42. 7) 32 (25. 8) 17 (13. 7) 15 (12. 1) 14 (11. 3)
The risk of intra-uterine death or severe birth defects, primarily phocomelia, is extremely high.
Ir- riskju ta ’ mewt intra- uterina jew mankamenti severi mat- twelid, prinċipalment fokomelija hija estremament għolja.
Thalidomide must not be used at any time during pregnancy (see sections 4.4 and 4.6).
Thalidomide m’ għandux jintuża fi kwalunkwe ħin waqt it- tqala (ara sezzjonijiet 4. 4 u 4. 6).
Thromboembolic events:
Avvenimenti tromboembolici:
An increased risk of DVT and PE has been reported in patients treated with thalidomide (see section 4.4).
Riskju ogħla ta ’ DVT u PE ġew irrapportati f’ pazjenti trattati b’ thalidomide (ara sezzjoni 4. 4).
Peripheral neuropathy is a very common, potentially severe, adverse reaction of treatment with thalidomide that may result in irreversible damage (see section 4.4).
In- newropatija periferali hija potenzjaliment reazzjoni avversa severa komuni ħafna tat- trattament b’ thalidomide li jista ’ jirriżulta fi ħsara rriversibbli (ara sezzjoni 4. 4).
Peripheral neuropathy generally occurs following chronic use over a period of months.
Newropatija periferali ġeneralment isseħħ wara l- użu kroniku fuq perijodu ta ’ xhur.
However, reports following relatively short- term use also exist.
Madankollu, rapporti wara perijodu relattivament qasir jeżistu wkoll.
Incidence of neuropathy events leading to discontinuation, dose reduction or interruption increases with cumulative dose and duration of therapy.
Aktar ma jkun hemm doża kumulattiva u ġbid fit- tul tat- terapija aktar ikun hemm inċidenza ta ’ episodji ta ’ newtropatija li jwasslu għat- twaqqif, tnaqqis tad- doża jew interruzzjoni.
Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all.
Is- sintomi jistgħu jseħħu ftit wara li t- trattament b’ thalidomide ikun waqaf u jew jista ’ jirrisolvi ruħu bil- mod jew ma jirrisolvi ruħu xejn.
Eighteen cases of overdose have been reported in the literature concerning doses up to 14.4 g.
Tmintax- il każ ta ’ doża eċċesiva ġew rapportati fil- letteratura medika dwar dożi sa 14. 4 g.
No fatalities have been reported and all overdose patients recovered without sequelae.
L- ebda fatalità ma ġiet irrapportata u l- pazjenti kollha b’ doża eċċessiva rkupraw mingħajr kumplikazzjonijiet.
There is no specific antidote for a thalidomide overdose.
M’ hemmx antidot għal doża eċċessiva ta ’ thalidomide.
In the event of an overdose, the patient’ s vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.
F’ każ ta ’ doża eċċessiva, is- sinjali vitali tal- pazjent għandhom jiġu monitorati u kura t’ appoġġ għandha tingħata sabiex tibqa ’ tinżamm il- pressjoni tad- demm u l- istat respiratorju.
Pharmacotherapeutic group: immunosuppressive agent, ATC code:
Kategorija farmakoterapewtika: mediċina immunosoppressiva, Kodiċi ATC:
Thalidomide has a chiral centre and is used clinically as a racemate of (+)-(R)- and (-)-(S)- thalidomide.
Thalidomide għandu ċentru kirali u jiġi użat klinikament bħala racemate ta ’ (+) - (R) - u (-) - (S) - thalidomide.
The spectrum of activity of thalidomide is not fully characterised.
L- ispektrum ta ’ l- attività ta ’ thalidomide għadu mhux magħruf għal kollox.
Thalidomide shows immunomodulatory anti-inflammatory and potential anti-neoplastic activities.
Thalidomide juri attivitajiet immunomodulatorji anti- infjammatorji u anti- neo- plastiċi potenzjali.
Data from in vitro studies and clinical trials suggest that the immunomodulatory, anti-inflammatory and anti-neoplastic effects of thalidomide may be related to suppression of excessive tumour necrosis factor-alpha (TNF-α) production, down-modulation of selected cell surface adhesion molecules involved in leukocyte migration and anti-angiogenic activity.
Tagħrif minn studji in vitro u provi kliniċi jissuġerixxu li l- effetti immunomodulatorji, anti- infjammatorji u anti- neoplastiċi ta ’ thalidomide jistgħu ikunu relatati mat- trażżin fil- produzzjoni eċċessiva tal- fattur ta ’ nekrosi tumurili- alfa (TNF- α), ibaxxi modulazzjoni ta ’ molekoli ta ’ adeżjoni fis- superfiċje ta ’ ċelluli magħżula involuti fil- migrazzjoni ta ’ lewkoċiti u attività anti- anġjoġenika.
Thalidomide is also a non-barbiturate centrally active hypnotic sedative.
Thalidomide huwa wkoll sedattiv ipnotiku mhux barbiturat u ċentralment attiv u.
It has no anti-bacterial effects.
M’ għandux effetti kontra l- batterja.
Clinical efficacy:
Effikaċja Klinika:
In
Riżultati minn studju IFM 99- 06, ta ’ Fażi 3, randomizzat, bit- tikketta murija, grupp parallel, multiċentrali wera vantaġġ ta ’ sopravivenza meta thalidomide jintuża f’ kombinazzjoni ma ’ melphalan u prednisone għal 12- il ċiklu ta ’ 6 ġimgħat fit- trattament ta ’ pazjenti li għadhom kif ġew djanjozati b’ majeloma multipla.
10 this study the age range of patients was 65-75 years, with 41% (183/ 447) of patients 70 years old or older.
F’ dan l- istudju l- età tal- pazjenti kienet tvarja bejn 65- 75 sena, b’ 41% (183/ 447) tal- pazjenti ikollhom 70 sena jew aktar.
The median dose of thalidomide was 217 mg and > 40% of patients received 9 cycles.
Id- doża medjana ta ’ thalidomide kienet ta ’ 217 mg u > 40% 10 tal- pazjenti rċevew 9 ċikli.
Melphalan and prednisone were dosed at 0.25 mg/ kg/ day and 2 mg/ kg/ day respectively on days 1 to 4 of each 6 weeks cycle.
Melphalan u prednisone kienu dożati f’ 0. 25 mg/ kg/ kuljum u 2 mg/ kg/ kuljum rispettivament fil- jiem 1 sa 4 ta ’ kull ċiklu ta ’ sitt ġimgħat.
Further to the per protocol analysis, an update was conducted for the IFM 99-06 study providing an additional 15 months follow-up data.
Barra mill- analiżi permezz tal- protokoll, sar ukoll aġġornament tas- sopravivenza totali għall- istudju IFM 99- 06 li pprovda 15- il xahar ta ’ dejta ta ’ follow- up.
The median overall survival (OS) was 51.6 ± 4.5 and 33.2 ± 3.2 months in the MPT and MP groups, respectively (97.5% CI 0.42 to 0.84).
Is- sopravivenza totali medjana kien ta ’ 51. 6 ± 4. 5 u 33. 2 ± 3. 2 xhur fil- gruppi MPT u MP, rispettivament (97. 5% CI 0. 42 sa 0. 84).
This 18 month difference was statistically significant with a hazard ratio of reduction of risk of death in the MPT arm of 0.59, 97.5% confidence interval of 0.42-0.84 and p-value of < 0.001 (see Figure 1).
Din id- differenza ta ’ 18- il xahar kienet statistikament sinifikanti bi proporzjon ta ’ periklu tat- tnaqqis tar- riskju tal- mewt fid- driegħ ta ’ MPT ta ’ 0. 59, intervall ta ’ kunfidenza ta ’ 97. 5% ta ’ 0. 42- 0. 84 u valur- p ta ’ < 0. 001 (ara Figura 1).
Overall survival according to treatment
Sopravivenza globali skond it- trattament
Proportion
Proporzjon
median ± se (month)
Żmien ta ’ Survival time O/ N + Trattament sopravivenza medjan median ± se (month) ± se (xhur)
33.2 ± 3.2
51, 6 ± 4, 5
Time from randomization (month)
Żmienfrom randomization (month) Time mir- randomization (xhur)
Absorption of thalidomide is slow after oral administration.
L- assorbiment ta ’ thalidomide huwa baxx wara l- għoti mill- ħalq.
The maximum plasma concentrations are reached 2-5 hours after administration.
Il- konċentrazzjonijiet massimi fil- plażma intlaħqu wara 2- 5 siegħat mill- għoti.
Co-administration of food delayed absorption but did not alter the overall extent of absorption.
L- għoti flimkien ma ’ l- ikel dewwem l- assorbiment imma ma biddilx il- medda globali ta ’ l- assorbiment.
The plasma protein binding of the (+)-(R) and (-)-(S) enantiomers was found to be 55% and 65% respectively.
L- irbit bejn plażma- protejina ta ’ (+) - (R) u (-) - (S) enantiomers instabu li huma 55% u 65% rispettivament.
Thalidomide is present in the semen of male patients at levels similar to plasma concentrations.
Thalidomide huwa preżenti wkoll fis- semen tal- pazjenti rġiel f’ livelli simili bħal tal- konċentrazzjonijiet tal- plażma.
Therefore, because of the known severe teratogenic effects of the product, during treatment with thalidomide and for 1 week after stopping the treatment, male patients must use condoms if their partner is pregnant or is of childbearing potential not using effective contraception (see section 4.4).
Għalhekk, minħabba l- effetti teratoġeniċi severi magħrufa tal- prodott, waqt it- trattament b’ thalidomide u għal 1 ġimgħa waħda wara li jintemm it- trattament, pazjenti rġiel għandhom jużaw kondoms jekk is- sieħba tagħhom hi tqila jew jekk tistax toħroġ tqila li mhix qed tuża kontraċettiv effettiv (ara sezzjoni 4. 4).
At the present time, the exact metabolic route and fate of thalidomide is not completely known in humans.
Fil- ħin attwali, il- passaġġ metaboliku eżatt u d- destin ta ’ thalidomide għadu mhux magħruf kompletament fil- bniedem.
Available data indicate that the medicinal product is eliminated mainly by non-enzymatic hydrolysis.
Tagħrif disponibbli jindika li l- prodott mediċinali jiġi eliminat prinċipalment b’ idrolisi spontanea (mhux enzimatika).
There is minimal cytochrome P450 catalysed hepatic metabolism of thalidomide.
Hemm metaboliżmu epatiku minimu kkatalizzat permezz ta ’ cytochrome P450 fuq thalidomide.
There are in vitro data indicating that prednisone may give rise to enzyme induction which could reduce the
Hemm dejta in vitro li tindika li prednisone għandu mnejn jikkawża induzzjoni enzimatika li tista ’ tnaqqas l- esponiment sistematiku ta ’ prodotti mediċinali li jintużaw fl- istess ħin.
11 systemic exposure of concomitantly used medicinal products.
11 Eliminazzjoni:
The mean elimination half-life of thalidomide in plasma following single oral doses between 50 mg and 400 mg was 5.5 to 7.3 hours.
Il- half- life ta ’ l- eliminazzjoni medja ta ’ thalidomide fil- plażma wara dożi orali singoli ta ’ bejn 50 mg u 400 mg kienet ta ’ bejn 5. 5 sa 7. 3 siegħat.
Total systemic exposure (AUC) is proportional to dose at single- dose conditions.
L- espożizzjoni sistematika totali (AUC) hija proporzjonali għad- doża f’ kundizzjonijiet ta ’ dożi singoli.
No time dependency of the pharmacokinetics has been observed.
Ma kienet osservata l- ebda dipendenza fuq il- ħin tal- farmakokinetiċi.
Hepatic and renal insufficiency:
Insuffiċjenza tal- fwied u tal- kliewi:
The pharmacokinetics of thalidomide in patients with impaired renal or hepatic function is unknown.
Il- farmakokinetiċi ta ’ thalidomide f’ pazjenti li jbatu minn indeboliment fil- funzjoni tal- kliewi jew tal- fwied mhumiex magħrufa.
In the male dog, after one year of dosing, reversible bile plugs in canaliculi were observed at exposures greater than 1.9 fold the human exposure.
Fil- każ ta ’ kelb raġel, wara sena ta ’ dożaġġ, kienu osservati pluggijiet riversibbli tal- bila f’ kanikuli f’ livell ta ’ esponiment akbar minn 1. 9 darba ta ’ l- esponiment uman.
Decreased platelet counts were noted in the mouse and rat studies.
Għedud imnaqqsa tal- plejtlets kienu osservati fi studji fuq ġrieden u firien.
The latter appears to be related to thalidomide and occurred at exposures greater than 2.4 fold the human exposure.
Ta ’ l- aħħar kienu jidhru li huma marbuta ma 'thalidomide u seħħew f’ esponimenti akbar minn 2. 4 darba l- esponiment uman.
This decrease did not result in clinical signs.
Dan it- tnaqqis ma wassalx għal sinjali kliniċi.
In a one-year dog study, enlarged and/ or blue discoloration of mammary glands and prolonged estrus were observed in females at exposures equal to 1.8 or greater than 3.6-fold the human exposure, respectively.
Fi studju ta ’ sena fuq klieb, kienu osservati tkabbir u/ jew telf ta ’ kulur għal kulur blu tal- glanduli mammarji u estrus prolongat fil- każ ta ’ nisa f’ livell ta ’ esponiment ta ’ 1. 8 jew akbar minn 3. 6 darba ta ’ l - esponiment uman rispettivament.
The relevance to humans is unknown.
Ir- relevanza għall- bnedmin mhix magħrufa.
The effect of thalidomide on thyroid function was assessed in both rats and dogs.
L- effett ta ’ thalidomide fuq il- funzjoni tat- tirojde kien analizzat kemm fuq il- firien u anke fuq il- klieb.
No effects were observed in dogs; however in rats, there was an apparent dose-dependent decrease in total and free T4 that was more consistent in the female.
Ma ġew osservati ebda effetti fuq il- klieb; madankollu fil- firien kien hemm tnaqqis apparenti fid- dipendenza tad- doża fit- total u it- T4 liberu kien aktar konsistenti fil- mara.
No mutagenic or genotoxic effect has been revealed when thalidomide was assayed in a standard battery of genotoxicity tests.
L- ebda effett mutaġeniku jew ġenotossiku ma ġie rivelat meta saru l- analiżi ta ’ thalidomide fuq batterija standard ta ’ testijiet ġenotossiċi.
No evidence of carcinogenicity was observed at exposures approximately 15, 13 and 39 times the estimated clinical AUC at the recommended starting dose in mice, male rats and female rats respectively.
L- ebda xhieda ta ’ karċinoġeniċità ma ġiet osservata f’ espożizzjonijiet ta ’ madwar 15, 13 u 39 darba l- AUC kliniku stmat tad- doża rakkomandata mibdija fi ġrieden, firien irġiel u firien nisa rispettivament.
Animal studies have demonstrated differences in species susceptibility to the teratogenic effects of thalidomide.
Studji fuq l- annimali wrew differenzi fis- suxxetibilità ta ’ l- effetti teratoġeniċi bejn l- ispeċi għal thalidomide.
In humans, thalidomide is a proven teratogen.
Fil- bniedem, thalidomide huwa teratoġen ipprovat.
A study in rabbits demonstrated no effect on fertility indices in males or females although testicular degeneration was observed in males.
Studji fuq fniek ma wrew ebda effetti fuq l- indiċi tal- fertilità fin- nisa u l- irġiel għalkemm kienet osservata deġenerazzjoni testikulari fl- irġiel.
A peri and postnatal toxicity study performed in rabbits with thalidomide administered at doses up to 500 mg/ kg/ day resulted in abortions, increased stillbirths and decreased pup viability during lactation.
Studju tat- tossiċità fi żmien tat- twelid u wara t- twelid li sar fuq il- fniek meta t- thalidomide ngħata f’ dożi sa 500 mg/ kg/ kuljum irriżulta f’ aborti, aktar frieħ jitwieldu mejta u tnaqqis fil- vijabilità tal- ferħ waqt l- irdigħ.
Pups from mothers treated with thalidomide had increased abortions, reduced body weight gain, alterations in learning and memory, decreased fertility, and reduced pregnancy index.
Frieħ minn ommijiet ittrattati b’ thalidomide kellhom żieda fl- aborti, tnaqqis fil- gwadann tal- piż tal- ġisem, tibdil fit- tagħlim u fil- memorja, tnaqqis fil- fertilità, u indiċi tat- tqala mnaqqsa.
Capsule contents:
Il- kontenut tal- kapsuli:
Anhydrous lactose Microcrystalline cellulose Crospovidone (Type A) Povidone (K90) Stearic acid Colloidal anhydrous silica
Lattosju anidru Microcrystalline cellulose Crospovidone (Tip A) Povidone (K90) Stearic acid Silika anidra kollojdali
Gelatin Titanium dioxide (E171)
12 Gelatin Titanium dioxide (E171)
Shellac Black iron oxide (E172) Propylene glycol
Xellak Black iron oxide (E172) Propylene glycol
6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali helf life
PVC/ PE/ Aclar/ aluminium blister containing 14 capsules
Strixxa tal- PVC/ PE/ Aclar/ aluminju li fiha 14- il kapsula
28 capsules (two blisters) in a wallet card.
28 kapsula (f’ żewġ strixxi) f’ kard ta ’ kartiera.
All unused capsules should be returned to the pharmacist at the end of treatment.
Il- kapsuli kollha mhux użati għandhom jingħataw lura lill- ispiżjar fit- tmiem tat- trattament.
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom Tel: +44 (0)1753 240600 Fax: +44 (0)1753 240899
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA Renju Unit Tel: +44 (0) 1753 240600 Fax: +44 (0) 1753 240899
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA): http: // www. emea. europa. eu.
14 ANNEX II
13 14 ANNESS II
Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA United Kingdom
Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA Renju Unit
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ● KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Prodott mediċinali jingħata bir- riċetta ristretta tat- tabib.
Medicinal product subject to restricted medical prescription. (see Annex 1:
(ara Anness 1:
Summary of Product Characteristics, section 4.2.).
Sommarju tal- Karatteristiċi tal- Prodott, Sezzjoni 4. 2)
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below. o Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional’ s Kit containing the following: o Healthcare professional booklet o Patient booklets o Patient cards o Summary of Product Characteristics, Package Leaflet and Labelling
L - MAH għandu jaqbel mad- dettalji tas- sistema ta ’ distribuzzjoni kkontrollata ma ’ l- Awtoritajiet Kompetenti Nazzjonali u għandu jimplimenta dan il- programm fuq bażi nazzjonali sabiex jiżgura li: o Qabel it- tnedija, it- tobba u l- ispiżjara kollha li beħsiebhom jippreskrivu jew jagħtu Thalidomide Celgene jirċievu ittra ta ’ l- Għażiż Professjonist tal- Kura tas- Saħħa kif deskritt hawn isfel. o Qabel ma jiktbu r- riċetti l- professjonisti kollha tal- kura tas- saħħa li beħsiebhom jiktbu riċetti (u bi ftehim ma ’ l- Awtorità Nazzjonali Kompetenti, jagħtu), Thalidomide Celgene qed jiġu provduti b’ Kitt Edukattiv tal- Professjonist fil- Qasam tal- Kura tas- Saħħa li fih dan li ġej: o Fuljett għall- professjonisti tal- kura tas- saħħa o Fuljetti edukattivi għall- pazjenti o Kards tal- Pazjent o Sommarju tal- Karatteristiċi tal- Prodott, Fuljett ta ’ tagħrif u Tikketta
The MAH shall implement a Pregnancy Prevention Programme (PPP) in each Member State.
L- MAH għandu jimplimenta Programm ta ’ Prevenzjoni ta ’ Tqala (PPP - Pregnancy Prevention Programme) f’ kull Stat Membru.
Details of the PPP should be agreed wth the National Competent Authorities in each Member State and put in place prior to the marketing of the medicinal product.
Detallji dwar il- PPP għandhom jiġu miftehma ma ’ l- Awtoritajiet Nazzjonali Kompetenti f’ kull Stat Membru u għandhom ikunu f’ posthom qabel it- tqegħid fis- suq tal- prodott mediċinali.
The MAH should agree the final text of the Dear Healthcare Professional letter and the contents of the Educational Healthcare Professional’ s Kit with the National Competent Authority in each Member State prior to marketing of the product and ensure that the materials contain the key elements as described below.
L- MAH għandu jaqbel mat- test aħħari ta ’ l- ittra ta ’ l- Għażiż Professjonist tal- Kura tas- Saħħa u l- kontenut tal- Kitt Edukattiv tal- Professjonist fil- Qasam tal- Kura tas- Saħħa ma 'l- Awtorità Kompetenti Nazzjonali f’ kull Stat Membru qabel mal- prodott jitqiegħed fis- suq u għandu jiżgura li l- materjali fihom l- elementi ewlenin kif deskritti hawn isfel.
The MAH should agree on the implementation of the patient card system in each Member State.
L- MAH għandu jaqbel ma ’ l- implimentazzjoni tas- sistema tal- kard tal- pazjent f’ kull Stat Membru.
The MAH should ensure that the educational materials are provided to and reviewed by the national patients’ organisations or if such an organisation does not exist or can not be involved, by a relevant patients group.
L- MAH għandu jiżgura li l- materjal edukattiv għandhom jingħataw u jkunu rreveduti mill- organizzazzjonijiet nazzjonali tal- pazjenti jew jekk tali organizzazzjoni ma teżistix jew ma tistax tkun involuta, minn grupp relevanti ta ’ pazjenti.
Results of the user testing will have to be provided to the national competent authority and final materials validated at a national level.
Ir- riżultati ta ’ l- ittesjtar ta ’ l- utent ser jingħataw lill- awtorità kompetenti nazzjonali u l- materjal finali għandu jkun validat f' livell nazzjonali.
The MAH should also agree with each Member State prior to the launch of the product: o The most appropriate strategies to monitor the off label use within national territories
Il- MAH għandu jaqbel ukoll ma ’ kull Stat Membru qabel it- tnedija tal- prodott: o L- aktar strateġiji adekwati biex jimmonitorjaw l- użu ta ’ l- off label fi ħdan it - territorji
16 o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP.
16 nazzjonali Il - ġbir ta ’ tagħrif dettaljat b’ ta ’ l- anqas ikun hemm demografiji tal- pazjent u o indikazzjoni sabiex jiġi monitorat mill- qrib l- użu off- label fi ħdan it- territorju nazzjonali Il- prassi ta ’ miżuri nazzjonali biex jassessjaw l- effettività u l- konformità mal- PPP. o
The MAH shall notify the EMEA and the appropriate national patients and victims representatives of the proposed launch date before launch in each Member State.
Il- MAH ser jinnotifika lill- EMEA u lir- rappreżentanti nazzjonali addattati tal- pazjenti u tal- vittmi bid- data proposta tat- tnedija qabel it- tnedija f’ kull Stat Membru.
Key elements to be included
Elementi ewlenin li għandhom jiġu inklużi
Dear Healthcare Professional letter The Dear Healthcare Professional letter will consist of two parts: • Core text as agreed by the CHMP • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o Procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed
Ittra ta ’ Għażiż Professjonist tal- Kura tas- Saħħa L- ittra ta ’ l- Għażiż Professjonist tal- Kura tas- Saħħa ser tikkonsisti minn żewġ partijiet: • Test ewlieni kif miftiehem mas- CHMP • Rekwiżiti speċifiċi nazzjonali miftehma ma ’ l- Awtorità Kompetenti Nazzjonali dwar: o Id- distribuzzjoni tal- prodott o Proċeduri li jiżguraw li l- miżuri addattati kollha saru qabel ma jkun distribwit thalidomide
Educational healthcare professional’ s kit The educational healthcare professional’ s kit shall contain the following elements: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority (if applicable to a Member State) using the forms provided in the “ Educational Healthcare Professional’ s Kit” o Safety advice relevant to all patients Description and management of thromboembolic and cardiovascular events, and peripheral neuropathy Disposal of unwanted medicine Not to donate blood during treatment and for one week after treatment ends
Kitt edukattiv għall- professjonisti tal- kura tas- saħħa Il- Kitt edukattiv tal- professjonisti tal- kura tas- saħħa għandu jkun fih l- elementi li ġejjin: • Fuljett għall- professjonisti tal- kura tas- saħħa o L- isfond ta ’ thalidomide, u l- isfond dwar Thalidomide Celgene u l- indikazzjoni liċenzjata tiegħu o Pożoloġija o Iż- żmien massimu ta ’ kemm isservi r- riċetta medika ■ 4 ġimgħat għan- nisa li jistgħu joħorġu tqal
o
■ 12- il ġimgħa għall- irġiel u għan- nisa li ma jistgħux joħorġu tqal
Algorithm for Pregnancy Prevention Plan implementation This shall assist with patient categorisation, and determination of required pregnancy prevention and testing measures.
o Teratogeniċità u l- bżonn li tiġi evitata espożizzjoni tal- fetu o L- obbligi tal- professjonist tal- kura tas- saħħa li biħsiebu jippreskrivi jew jagħti Thalidomide Celgene inkluż ■ Il- ħtieġa li jingħata parir komprensiv u servizz ta 'pariri lil pazjenti
o
■ Il- pazjenti għandhom ikunu kapaċi jissodisfaw il- kondizzjonijiet
Pregnancy Prevention Programme information Definition of women of childbearing potential (WCBP) and actions the prescriber should take if childbearing status is unclear Information on what is effective contraception Safety advice for WCBP • Need to avoid foetal exposure • Pregnancy prevention requirement, definition and need for adequate contraceptive methods
għall- użu mingħajr periklu ta ’ thalidomide ■ Il- ħtieġa li l- pazjenti jingħataw il- materjal edukattiv adattat tal- pazjenti
17
Irrapporta kwalunkwe tqala, newropatija jew avveniment avvers lil Celgene u lill- awtorità lokali tas- saħħa (jekk dan hu applikabbli għal Stat Membru) billi tuża l- formoli li jinsabu fil - “ Kitt Edukattiv tal- Professjonist fil- Qasam tal- Kura tas- Saħħa ”
•
Rakkomandazzjoniet dwar is- Sigurtà lil kull pazjent o ■ Deskrizzjoni u ġestjoni ta ’ episodji tromboemboliċi u episodji kardjovaskulari, u newropatija periferali ■ Ir- rimi ta ’ mediċina mhix meħtieġa ■ M’ għandekx tagħti d- demm waqt it- trattament u għal ġimgħa waħda wara li jintemm it- trattament
That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception
Algoritma għall- implimentazzjoni tal- Pjan tal- Prevenzjoni tat- Tqala o ■ Dan għandu jgħin il- kategorizzazzjoni tal- pazjenti, u d- determinazzjoni tal- miżuri meħtieġa tal- prevenzjoni tat- tqala ta ’ l- ittestjar.
• Pregnancy testing requirements o Advice on suitable tests o Frequency (before commencing, monthly during treatment and after finishing treatment) • Need to stop Thalidomide Celgene immediately upon suspicion of pregnancy • Need to tell treating doctor immediately upon suspicion of pregnancy Safety advice for men • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not using effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom during intercourse • That he should not donate semen during therapy and for one week after discontinuation of thalidomide
Tagħrif dwar x’ inhu kontraċettiv effettiv ■ Rakkomandazzjonijiet dwar is- Sigurtà għal WCPB ■ • Il- bżonn li jiġi evitat l- espożizzjoni lil fetu • Rekwiżit ta ’ prevenzjoni ta ’ tqala u tifsira u bżonn ta ’ metodi ta ’ kontraċezzjoni adegwati • Li jekk ikollha bżonn tibdel jew ma tkomplix tuża l- metodu tagħha ta 'kontraċettivi hi għandha tavża lil:
o
- lit- tabib li qed jiktbilha r- riċetta tat- thalidomide li m’ għadhiex tieħu
Pregnancy reporting requirements Stop Thalidomide Celgene immediately upon suspicion of pregnancy Refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation Complete pregnancy reporting form as provided in the “Educational Healthcare Professional’s Kit” Local contact details for reporting of any suspected pregnancy
bidlet il- metodu tagħha tal- kontraċettivi • Ħtiġijiet għal testijiet ta ’ tqala o Rakkomandazzjonijiet għal testijiet adattati o Frekwenza (qabel tibda, kull xahar waqt it- trattament u wara li jispiċċa t- trattament) • Il- bżonn li Thalidomide Celgene jitwaqqaf minnufih ma ’ l- anqas suspett ta ’ tqala • Il- bżonn li tgħid lit- tabib li qed jieħu ħsiebek minnufih ma ’ l- anqas suspett ta ’ tqala Rakkomandazzjonijiet dwar is- sigurtà għall- irġiel ■ • Il- ħtieġa li tiġi evitata l- espożizzjoni għal fetu • Li thalidomide jinsab fl- isperma u l- ħtieġa li jintużaw kondoms jekk is- sieħba sesswali tagħhom tkun tqila jew hi mara li tista ’ toħroġ tqila li mhux qed tuża kontraċettiv effettiv • Jekk is- sieħba tiegħu toħroġ tqila, hu għandu javża minnufih lit- tabib li jkun qiegħed jikkurah u dejjem għandu juża kondom meta jkollhom x' jaqsmu sesswalment ma 'xulxin • Programm ta ’ Prevenzjoni ta ’ Tqala għal persuni li jiktbu r- riċetti
• Pregnancy initial and outcome reporting forms • Post-marketing and compliance assessment (as applicable to a Member State) • Neuropathy and adverse reaction reporting forms
Rekwiżiti dwar raportaġġ ta ’ tqala o ■ Waqqaf Thalidomide Celgene minnufih malli hemm suspett ta ’ tqala ■ Irreferi lil pazjent għand tabib speċjalizzat jew b’ esperjenza fil- qasam tat- teratoloġija għal parir u evalwazzjoni ■ Imla l- formola tar- rappurtaġġ li tingħata fil - "Kitt Edukattiv tal- Professjonist fil- Qasam tal- Kura tas- Saħħa" ■ Dettalji fejn wieħed jista ’ jikkontattja biex jirraporta dwar suspett ta ’ tqala • Formoli inizjali u tar- riżultat dwar ir- rapportaġġ ta ’ tqala • Analiżi ta ’ wara t- tqegħid fis- suq u dwar konformità (hekk kif applikabbli għal Stat Membru) • Formoli dwar ir- rapportaġġ ta ’ newropatija u reazzjoni avversa
Female patient of childbearing potential Female patient of non-childbearing potential Male patient
• Formoli biex jinbeda t- trattament o Għandu jkun hemm 3 tipi ta ’ formoli biex jinbeda t- trattament: ■ Pazjenta mara li jista ’ jkollha t- tfal ■ Pazjenta mara li ma jistax ikollha t- tfal ■ Pazjent raġel
o
Kull Formola biex Jinbeda t- Trattament għandu jkollha l- elementi li ġejjin: o ■ Twissija dwar teratoġeniċità ■ Data ta 'servizz ta' pariri ■ Affermazzjoni tal- fehim mill- pazjent dwar ir- riskju ta ’ thalidomide u l- miżuri PPP
Teratogenicity warning Date of counselling Affirmation of patient understanding regarding the risk of thalidomide and the PPP measures Patient details, signature and date Prescriber name, signature and date Aim of this document i.e. as stated in the PPP: “The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide.
18 Dettalji dwar il- pazjent, firma u data ■ Il- persuna li qed tikteb ir- riċetta, firma u data ■ L- għan ta ’ dan id- dokument i. e. hekk kif inhu ddikjarat fil- PPP: “ L- għan ■ tal- formola tal- bidu tat- trattament hu li jipproteġi l- pazjenti u kwalunkwe fetu li jista ’ jkun hemm billi jiżgura li l- pazjenti jkunu informati kompletament dwar u jifhmu r- riskju tat- teratoġeniċità u reazzjonijiet effetti avversi oħra marbuta ma 'l- użu ta ’ thalidomide.
It is not a contract and does not absolve anybody from his/her responsibilities with regard to the safe use of the product and prevention of foetal exposure.”
Mhux kuntratt u ma jassolva lil ħadd mir- responsabbilitajiet tiegħu/ tagħha dwar l- użu sigur tal- prodott u l- prevenzjoni ta ’ l- esponiment tal- fetu. ”
18
Formoli tal- bidu tat- trattament għall- pazjenti nisa li jistgħu joħorġu tqal għandhom o jinkludu; ■ Konfirma li t- tabib iddiskuta dan li ġej: • Il- bżonn li jiġi evitat esponiment għall- fetu • Li jekk hi tqila jew biħsieba issir tqila, hi m' għandhiex tieħu Thalidomide Celgene • Il- bżonn ta ’ kontraċettiv effettiv mingħajr waqfien, 4 ġimgħat qabel ma tibda t- trattament, matul il- perijodu kollu ta ’ trattament, u 4 ġimgħat wara t- tmiem tat- trattament • Li jekk ikollha bżonn tibdel jew twaqqaf il- metodu tagħha ta ’ kontraċettiv hi għandha tavża lit -:
Treatment initiation forms for female patients with childbearing potential should also include:
- tabib, li qed jagħtiha bir- riċetta medika l- kontraċettiv tagħha, li qed
o
tieħu thalidomide
Treatment initiation forms for female patients with no childbearing potential should also include:
- tabib li qed jagħtiha bir- riċetta medika thalidomide li hi waqfet jew
C onfirmation that the physician has discussed the following: • That she should not share the treatment with any other person • That she should not donate blood during therapy and for one week following discontinuation of thalidomide • That she should return the capsules to the pharmacist at the end of treatment
biddlet il- metodu tagħha ta ’ kontraċettiv • Il- bżonn ta 'testijiet tat- tqala i. e qabel it- trattament, kull 4 ġimgħat matul it- trattament u wara t- trattament • Il- bżonn li tieqaf minnufih milli tieħu Thalidomide Celgene hekk kif ikun hemm suspett ta ’ tqala • Il- bżonn li jikkuntattjaw lit- tabib tagħhom minnufih hekk kif ikun hemm suspett ta ’ tqala • Li hi m’ għandha taqsam it- trattament ma ’ ħadd • Li hi m’ għandhiex tagħti demm matul it- terapija u għal ġimgħa wara t- twaqqif ta ’ thalidomide • Li hi għandha tagħti lura l- kapsuli lill- ispiżjar fit- tmiem tat- trattament
Treatment initiation forms for male patients should also include:
Formoli tal- bidu tat- trattament għall- pazjenti nisa li ma jistgħux joħorġu tqal o għandhom jinkludu:
Confirmation that the physician has discussed the following: • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not on effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom • That he should not donate blood or semen during therapy and for one week following discontinuation of thalidomide • That he should not share the treatment with any other person • That he should return the capsules to the pharmacist at the end of treatment
Konferma li t- tabib kien iddiskuta dan li ġej: ■ • Li hi m’ għandha taqsam it- trattament ma ’ ħadd • Li m’ għandhiex tagħti d- demm matul it- terapija u għal ġimgħa wara t- twaqqif ta ’ thalidomide • Li hi għandha tagħti lura l- kapsuli lill- ispiżjar fit- tmiem it- trattament
• Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing status potential o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if female with childbearing potential)
Formoli tal- bidu tat- trattament għall- pazjenti rġiel għandhom jinkludu wkoll: o Konferma li t- tabib kien iddiskuta dan li ġej: • Il- bżonn li jiġi evitat esponiment għall- fetu • Li thalidomide jinsab fis- semen u l- bżonn li jintużaw kondoms jekk is- sieħba sesswali hi tqila jew hi mara li tista ’ toħroġ tqila li mhix qed tieħu kontraċettiv effettiv • Li jekk is- sieħba toħroġ tqila hu għandu javża lit- tabib kuranti minnufih u dejjem għandu juża kondom • Li hu m’ għandux jagħti demm jew semen matul it- terapija u għal ġimgħa wara t- twaqqif ta ’ lenalidomide • Li hu m’ għandu jaqsam it- trattament ma ’ ħadd • Li hu għandu jagħti lura l- kapsuli lill- ispiżjar fit- tmiem tat - trattament
verificati on of initial negative pregnancy test prior to start of treatment (if female with childbearing potential)
19 • Kards tal- pazjent u/ jew għodda simili: o verifika li ngħata servizz adattat ta ’ pariri o dokumentazzjoni ta 'l- istatus jekk tistax toħroġ tqila o kaxxa (jew simili) li t- tabib jittikkja biex jikkonfirma li l- pazjent qed juża kontraċettiv effettiv (jekk hi mara li tista ’ toħroġ tqila) o Il- fuljetti jistgħu jkunu ta ’ 3 tipi, jew fuljett ta ’ pazjent wieħed li jgħaqqad erifika ta ’ test inizjali negattiv tat- tqala qabel il- bidu tat- trattament (jekk mara li tista ’ toħroġ tqila) o Dati u riżultati tat- test tat- tqala
• Educational patient booklets: o The booklets can be of 3 types or a single patient booklet that combines the information for each patient category:
• Fuljetti Edukattivi tal- Pazjenti o Il- fuljetti jistgħu jkunu ta ’ 3 tipi, jew fuljett ta ’ pazjent wieħed li jgħaqqad l- informazzjoni għal kull kategorija ta ’ pazjenti:
B ooklet for women of childbearing potential and their partners Booklet for women patients who are not of childbearing potential Booklet for male patients
Fuljett għal nisa li jistgħu joħorġu tqal u l- partner tagħhom Fuljett għal pazjenti nisa li ma jistax ikollhom it- tfal Fuljett għall- pazjenti rġiel
All b ooklets should contain the following information That Thalidomide Celgene is teratogenic That Thalidomide Celgene may cause thromboembolism, cardiovascular events and neuropathy Description of the patient card and its use in the individual Member State National or other applicable specific arrangements for a prescription for thalidomide to be dispensed That Thalidomide Celgene must not be given to any other person That the patient should not donate blood That the patient should tell their doctor about any adverse events That any unused capsules should be returned to the pharmacist at the end of the treatment
Il- fuljetti kollha għandu jkun fihom dawn l- elementi li ġejjin: o Li Thalidomide Celgene huwa teratoġeniku Li Thalidomide Celgene għandu mnejn jikkawża tromboemboliżmu, episodji kardjovaskulari u newropatija Deskrizzjoni tal- kard tal- pazjent u l- użu tagħha fl- Istat Membru Individwali Arranġamenti nazzjonali jew oħrajn applikabbli speċifiċi sabiex ikun jista ’ jingħata thalidomide b’ riċetta Li m’ għandekx tagħti Thalidomide Celgene lil ħaddieħor Li l- pazjent m’ għandux jagħti d- demm Li l- pazjent għandu javża lit- tabib tiegħu b’ kull effett avvers li jkollu Li kwalunkwe kapsuli mhux użati għandhom jingħataw lura lill- ispiżjar fi tmiem tat- trattament
The following information should also be provided in the appropriate booklets:
o L- informazzjoni li ġejja għandha wkoll tiġi provduta fil- fuljetti xierqa:
Female patient of childbearing potential • The need to avoid foetal exposure • The need for effective contraception • That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception • The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment • The need to stop Thalidomide Celgene immediately upon suspicion of pregnancy • The need to contact their doctor immediately upon suspicion of pregnancy
Pazjenti nisa li jistgħu joħorġu tqal • Il- ħtieġa li tiġi evitata espożizzjoni lit- tarbija • Il- bżonn ta ’ kontraċettiv effettiv • Li jekk hi għandha bżonn tibdel jew twaqqaf il- metodu tagħha ta ’ kontraċettiv hi għandha tinforma:
Male patients • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not on effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom • That he should not donate semen during therapy and for one week following discontinuation of thalidomide
- lit- tabib, li qed jagħtiha bir- riċetta medika il- kontraċettiv tagħha, li hi
• OTHER CONDITIONS
qed tieħu t- thalidomide
Pharmacovigilance system
- lit- tabib, li qed jagħtiha bir- riċetta medika thalidomide, li m’ għadhiex
20 The MAH must ensure that the system of pharmacovigilance, as described in version 5.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
• KONDIZZJONIJIET OĦRA 20 Sistema ta ’ Farmakoviġilanza L- MAH trid tiżgura li s- sistema ta ’ farmakoviġilanza, hekk kif hi deskritta f’ verżjoni 5. 1 ippreżentata f’ Modul 1. 8. 1 ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq hi stabbilita u tiffunzjona qabel u waqt li l- prodott ikun fuq is- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 6.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Immaniġġjar ta ’ Riskju L- MAH jimpenja ruħu li jagħmel studji u attivitajiet oħra ta ’ farmakoviġilanza li huma dettaljati fil- Pjan ta ’ Farmakoviġilanza, hekk kif ġew miftehma f’ verżjoni 6. 0 tal- Pjan ta 'l- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modul 1. 8. 2 ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornament sussegwenti tal- RMP hekk kif inhu miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linjagwida ta ’ CHMP dwar is- Sistemi ta ’ Immaniġġjar tar- Riskju għall- prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin tar- Rapport Perjodiku li jmiss ta 'l- Aġġornament tas- Sigurtà (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn dan, RMP aġġornat għandu jkun sottomess • Meta jasal tagħrif ġdid li għandu mnejn jolqot l- Ispeċifikazzjoni kurrenti tas- Sigurtà, Pjan tal- Farmakoviġilanza jew attivitajiet tat- tnaqqis tar- riskju • Fi żmien 60 ġurnata minn meta tintlaħaq data importanti (farmakoviġilanza jew tnaqqis tar- riskju) • Jekk ikun hemm talba mill- EMEA
WALLET CARD
KARD TAL- KARTIERA
Thalidomide Celgene 50 mg hard capsules Thalidomide
Thalidomide Celgene 50 mg kapsuli iebsin Thalidomide
Each capsule contains 50 mg of thalidomide.
Kull kapsula fiha 50 mg ta ’ thalidomide.
Also contains:
Fiha wkoll:
Lactose.
Lattosju.
28 hard capsules
28 kapsula ibsin
WARNING:
TWISSIJA:
Thalidomide causes birth defects and foetal death.
Thalidomide jikkawża mankamenti fit- twelid u mewt tal- fetu.
Patients must follow the Thalidomide Celgene Pregnancy Prevention Programme.
Il- Pazjenti għandhom isegwu l- Programm ta ’ Prevenzjoni ta ’ Tqala ta ’ Thalidomide Celgene.
May cause drowsiness, if affected do not drive or operate machines.
Jista ’ jikkaġuna l- ħedla, jekk affettwat m’ għandekx issuq jew tħaddem inġenji.
24 11.
24 Prodott medċinali mhux użat għandu jiġi ritornat lura lill- ispiżjar tiegħek.
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA Renju Unit
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
WARNING Thalidomide causes birth defects and foetal death.
TWISSIJA Thalidomide jikkaġuna difetti fit- twelid u mewt tal- fetu.
Do not take thalidomide if you are pregnant or could become pregnant.
Tiħux thalidomide jekk int tqila jew tista ’ toħroġ tqila.
You must follow the contraception advice given to you by your doctor.
Għandek issegwi li jagħtik it- tabib tiegħek l- parir dwar il- kontraċezzjoni
You may need to read it again • If you have further questions, please ask your doctor or pharmacist • This medicine has been prescribed for you.
Jista jkollok bżonn terġa ’ taqrah • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek • Din il- mediċina ġiet mogħtija lilek.
Never pass it on to others.
Qatt ma għandek tagħtiha lil persuni oħra.
It may harm them, even if their symptoms are the same as yours • If any of your side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
Tista ’ tagħmlilhom il- ħsara anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
What Thalidomide Celgene is and what it is used for 2.
X’ inhu Thalidomide Celgene u għalxiex jintuża 2.
Before you take Thalidomide Celgene 3.
Qabel ma tieħu Thalidomide Celgene 3.
How to take Thalidomide Celgene 4.
Kif għandek tieħu Thalidomide Celgene 4.
How to store Thalidomide Celgene 6.
Kif taħżen Thalidomide Celgene 6.
WHAT THALIDOMIDE CELGENE IS AND WHAT IT IS USED FOR
X’ INHU THALIDOMIDE CELGENE U GĦALXIEX JINTUŻA
What Thalidomide Celgene is:
X’ inhu Thalidomide Celgene:
Thalidomide Celgene contains an active substance called thalidomide.
Thalidomide Celgene fih sustanza attiva msejħa thalidomide.
This belongs to a group of medicines known as ‘immunosuppressive’ medicines.
Din tappartjeni għal grupp ta ’ mediċini magħrufa bħala mediċini ‘ immunosuppressivi ’.
These work by acting on the cells involved in your immune system.
Dawn jaħdmu billi jaġixxu fuq iċ- ċelloli involuti fis- sistema immuni tiegħek.
The immune system is part of the body’s defence which helps to fight illness and infection.
Is- sistema mmuni hija parti mid- difiża tal- ġisem li tissielet il- mard u l- infezzjonijiet.
What Thalidomide Celgene is used for:
Għalxiex jintuża Thalidomide Celgene:
Thalidomide Celgene is used to treat multiple myeloma, a cancer of the bone marrow.
Thalidomide Celgene jintuża biex jittratta majeloma multipla, kanċer tal- mudullun.
Multiple myeloma is a type of blood cancer that affects the white blood cells that produce antibodies.
Majeloma multipla hi tip ta ’ kanċer fid- demm li jolqot iċ- ċelluli bojod tad- demm li jipproduċu l- antikorpi.
It is used in combination with two other medicines, melphalan and prednisone, for the first line treatment of multiple myeloma in patients ≥ 65 years or those who cannot receive high dose chemotherapy.
Huwa jintuża f’ kombinazzjoni ma ’ żewġ mediċini oħra, melphalan u prednisone, għat- trattament ta ’ l- ewwel linja ta ’ majeloma multipla f' pazjenti li għandhom aktar minn 65 sena jew fil- każ ta ’ dawk li ma jistgħux jirċievu doża għolja ta ’ kimoterapija.