qanastek/EMEA-V3 huggingface dataset:
41 Reproductive system and breast disorders Common:
Disturbi fis- sistema riproduttiva u fis- sider Komuni:
Injury, poisoning and procedural complications Common:
46 Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Komuni:
In total, 353 patients were evaluated in the MM-009 study; 177 in the lenalidomide/dexamethasone group and 176 in the placebo/dexamethasone group and, in total, 351 patients were evaluated in the MM-010 study; 176 in the lenalidomide/dexamethasone group and 175 in the placebo/dexamethasone group.
47 kienu evalwati fi studju MM- 010; 176 fil- grupp ta ’ lenalidomide/ dexamethasone u 175 fil- grupp tal - plaċebo/ dexamethasone.
36.9, 58.4) in patients treated with lenalidomide/dexamethasone versus 2 0.1 weeks (95% CI:
36. 9, 58. 4) f’ pazjenti kkurati b’ lenalidomide/ dexamethasone kontra 20. 1 ġimgħat (95% CI:
Lenalidomide has an asymmetric carbon atom and can therefore exist as the optically active forms S(-) and R(+).
Lenalidomide għandu atomu asimmetriku tal- karbonju u għalhekk jista ’ jeżisti bħala l- forom attivi b’ mod ottiku S (-) u R( +).
Gelatin Titanium dioxide (E171) Indigo carmine (E132)
Gelatin Titanium dioxide (E171) Indigo carmine (E132)
45 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Revlimid 25 mg hard capsules
Revlimid 25 mg kapsuli iebsin
Each capsule contains 25 mg of lenalidomide.
Kull kapsula fiha 25 mg ta ’ lenalidomide.
Each capsule contains 200 mg of anhydrous lactose.
Kull kapsula fiha 200 mg ta ’ anhydrous lactose.
White capsules marked “REV 25 mg”.
Kapsuli bojod immarkati “ REV 25 mg ”.
Recommended dose adjustments during treatment and restart of treatment Dose adjustments, as summarised below, are recommended to manage grade 3 or 4 neutropenia or thrombocytopenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
53 Aġġustamenti rakkomandati tad- doża matul il- kura u l- bidu mill- ġdid tal- kura Aġġustamenti tad- doża, murija fil- qosor hawn taħt, huma rakkomandati biex timmaniġġja newtropenja jew tromboċitopenja ta ’ grad 3 jew 4, jew xi tossiċità oħra ta ’ grad 3 jew 4 li tkun iġġudikata li tkun marbuta ma ’ lenalidomide.
47 • Dose reduction steps
• Passi biex tnaqqas id- doża
No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out.
54 effikaċja ma kienet osservata bejn dawn il- pazjenti u l- pazjenti li kienu iżgħar, iżda l- predispożizzjoni ikbar f’ individwi li għandhom iktar żmien ma tistax tiġi eskluża.
48 No dose adjustments are required for patients with mild renal impairment.
L- ebda aġġustamenti fid- doża m’ huma meħtieġa għal pazjenti b’ indeboliment ħafif renali.
15 mg every other day **
15 mg kull jumejn **
Counselling For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met: • She understands the expected 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
55 • Operazzjoni salpingo- oophorectomy bilaterali, jew isterektomija li jkunu saru fil- passat • Ġenotip XY, sindromu ta ’ Turner, aġenesi ta ’ l- utru. * Amenorrea wara terapija tal- kanċer ma teskludix li l- mara jista ’ jkollha tfal.
49 • 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 lenalidomide is dispensed following a negative pregnancy test • She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation • She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide.
Pariri Għal nisa li jista ’ jkollhom tfal, lenalidomide hu kontra- indikat ħlief jekk dawn li ġejjin kollha jkunu sodisfatti: • Hi tifhem ir- riskju teratoġeniku mistenni lit- tarbija mhix imwielda • Hi tifhem il- ħtieġa għal kontraċezzjoni effettiva mingħajr interruzzjoni, 4 ġimgħat qabel tibda l - kura, matul il- perijodu kollu tal- kura, u 4 ġimgħat wara t- tmiem tal- kura • Anki jekk mara li jista ’ jkollha tfal ikollha l- amenorrea, trid issegwi l- pariri kollha dwar kontraċezzjoni effettiva • Hi għandha tkun kapaċi li tkun konformi b’ miżuri ta ’ kontraċezzjoni effettiva • Hi nfurmata u tifhem il- konsegwenzi potenzjali tat- tqala u l- ħtieġa li tieħu parir malajr jekk hemm riskju ta ’ tqala • Hi tifhem il- ħtieġa li tibda l- kura malli tingħata lenalidomide wara test tat- tqala negattiv • Hi tifhem il- ħtieġa u taċċetta li tagħmel test tat- tqala kull 4 ġimgħat minbarra f’ każ ta ’ sterilizzazzjoni tat- tubi kkonfermata • Tirrikonoxxi li tifhem il- perikli u l- prekawzjonijiet meħtieġa marbuta ma ’ l- użu ta ’ lenalidomide.
50 requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Din il- ħtieġa tinkludi nisa li jista ’ jkollhom tfal li jipprattikaw astinenza sesswali assoluta u kontinwa.
Concomitant administration of erythropoietic agents or previous history of DVT may also increase thrombotic risk in these patients.
57 eritropojetiċi jew storja medika ta ’ DVT fil- passat, jistgħu wkoll iżidu r- riskju trombotiku f’ dawn il - pazjenti.
The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
58 tumur kbir jew estensiv qabel il- kura.
52 to reduced efficacy of drugs, including hormonal contraceptives, is not expected if lenalidomide is administered alone.
Għalhekk, l- induzzjoni li twassal għal tnaqqis fl- effikaċja tal- mediċini, li jinkludu kontraċettivi ormonali, mhijiex mistennija jekk lenalidomide jingħata waħdu.
Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see section 5.3).
59 Lenalidomide ipproduċa malformazzjonijiet fix- xadini simili għal dawk deskritti b’ thalidomide (ara sezzjoni 5. 3).
53 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
54 Blood and lymphatic system disorders Very Common:
Disturbi tad- demm u tas- sistema limfatika Komuni ħafna:
Nervous system disorders Common:
61 Disturbi fis- sistema nervuża Komuni:
Hepatobiliary disorders Uncommon:
Disturbi fil- fwied u fil- marrara
56 Reproductive system and breast disorders Common:
Disturbi fis- sistema riproduttiva u fis- sider Komuni:
Injury, poisoning and procedural complications Common:
63 Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Komuni:
The primary efficacy endpoint in both studies was time to progression (TTP).
Ir- riżultat aħħari ta ’ l- effikaċja primarja fiż- żewġ studji kien iż- żmien sal- progressjoni (time to progression - TTP).
In total, 353 patients were evaluated in the MM-009 study; 177 in the lenalidomide/dexamethasone group and 176 in the placebo/dexamethasone group and, in total, 351 patients were evaluated in the MM-010 study; 176 in the lenalidomide/dexamethasone group and 175 in the placebo/dexamethasone group.
B’ kollox, 353 pazjenti kienu evalwati fl- istudju MM- 009; 177 fil- grupp ta ’ lenalidomide/ dexamethasone u 176 fil- grupp tal- plaċebo/ dexamethasone, u b’ kollox, 351 pazjent kienu evalwati fi studju MM- 010; 176 fil- grupp ta ’ lenalidomide/ dexamethasone u 175 fil- grupp tal - plaċebo/ dexamethasone.
In both studies, the baseline demographic and disease-related characteristics were comparable between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
64 Fiż- żewġ studji, il- linja bażi demografika u l- karatteristiċi relatati mal- marda kienu komparabbli bejn il- gruppi ta ’ lenalidomide/ dexamethasone u tal- plaċebo/ dexamethasone.
1-ye ar Overall Survival rate
ta ’ Sopravivenzal
Developmental toxicity studies were previously conducted in rabbits.In these studies, rabbits were administered 3, 10 and 20 mg/kg/day orally..
F’ dawn l- istudji, il- fniek ngħataw 3, 10 u 20 mg/ kg/ kuljum oralment.
60 Not applicable.
Ma jgħoddx f’ dan il- każ.
61 ANNEX II
69 ANNESS II
Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA United Kingdom
Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar, Gwent NP22 3AA Ir- Renju Unit
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: • Prior to launch, all doctors who intend to prescribe Revlimid and all pharmacists who may dispense Revlimid receive a Direct Healthcare Professional Communication as described below. • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) Revlimid are provided with a physician information pack containing the following: o Educational Health Care Professional’s kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SPC) and Package Leaflet and Labelling.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- suq għandu jiftiehem dwar id- dettalji ta ’ sistema ta ’ distribuzzjoni kkontrollata ma ’ l- Awtoritajiet Kompetenti Nazzjonali u jrid jimplimenta programm bħal dan b’ mod nazzjonali biex jiżgura li: • Qabel il- lanċjar, it- tobba kollha li jkollhom l- intenzjoni li jagħtu riċetta għal Revlimid, u l - ispiżjara kollha li jistgħu jagħtu Revlimid, jirċievu Komunikazzjoni Diretta tal- Professjonisti fil- Qasam tas- Saħħa kif deskritt hawn taħt. • Qabel ma jagħtu r- riċetta (fejn xieraq, u bi ftehim ma ’ l- Awtorità Kompetenti Nazzjonali, jagħtu l- mediċina) il- Professjonisti fil- Qasam tas- Saħħa kollha li jkollhom l- intenzjoni li jagħtu riċetta (u jagħtu) Revlimid jiġu pprovduti b’ pakkett ta ’ tagħrif għat- tobba li jkun fih dan li ġej: o Kitt edukattiv tal- Professjonisti fil- Qasam tas- Saħħa o Pamflets edukattivi għall- Pazjenti o Kards tal- pazjent o Sommarju tal- Karatteristiċi tal- Prodott (SPC) u Fuljett ta ’ Tagħrif u Tikketta
The MAH shall implement a pregnancy prevention programme (PPP) in each Member State.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- suq għandu jimplimenta Programm tal - Prevenzjoni tat- Tqala (PPP, Pregnancy Prevention Programme) f’ kull Stat Membru.
The MAH should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- suq għandu jaqbel dwar il- kliem finali tal - Komunikazzjoni Diretta tal- Professjonisti fil- Qasam tas- Saħħa u l- kontenut tal- pakkett ta ’ tagħrif għat- tobba ma ’ l- Awtoritajiet Kompetenti Nazzjonali f’ kull Stat Membru u jiżgura li l- materjali fihom l- elementi essenzjali kif deskritti hawn taħt.
The MAH should agree on the implementation of the patient card system in each Member State.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- suq għandu jaqbel dwar l- implimentazzjoni tas- sistema tal- kard tal- pazjent f’ kull Stat Membru.
The MAH should also agree with each Member State prior to the launch of the product: • The feasibility of collecting detailed data relating to the indication in order to monitor closely the off-label use within the national territory • The set-up of national measures to assess the effectiveness of and compliance with the PPP.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- suq għandu jaqbel ukoll ma ’ kull Stat Membru qabel il- lanċjar tal- prodott dwar: • Il- possibilta` li tinġabar data dettaljata relatata mal- indikazzjoni biex issegwi mill- qrib l- użu barra mit- tikketta ġewwa t- territorju nazzjonali • It- twaqqif ta’ miżuri nazzjonali li jistimaw l- effikaċja u l- konformita` mal- PPP.
Key elements t o be included
71 Elementi essenzjali li għandhom jiddahhlu
63
Il- Komunikazzjoni Diretta tal- Professjonist fil- Qasam tas- Saħħa ser tkun tikkonsisti f’ żewġ partijiet: • Il- kliem ewlieni kif maqbul mis- CHMP. • Ħtiġijiet speċifiċi nazzjonali maqbula ma ’ l- Awtorità Kompetenti Nazzjonali dwar: o Distribuzzjoni tal- prodott o Biex tiżgura li l- miżuri adattati kollha twettqu qabel ma jingħata Revlimid
Distribution of the product To ensure that all appropriate measures have been performed prior to Revlimid being dispensed
Il- Kitt Edukattiv tal- Professjonist fil- Qasam tas- Saħħa
The Educational Healthcare Professional’s Kit
Il- Kitt Edukattiv tal- Professjonisti fil- Qasam tas- Saħħa ser ikun fih l- elementi li ġejjin: • Sfond fil- qosor dwar lenalidomide u l- indikazzjoni liċenzjata tiegħu • Pożoloġija • Il- ħtieġa li tiġi evitata l- espożizzjoni tal- fetu minħabba t- teratoġeniċità ta ’ lenalidomide fl - annimali u l- effett teratoġeniku mistenni ta ’ lenalidomide fil- bnedmin, li jinkludi sommarju tar- riżultati interim ta ’ studju CC- 5013- TOX- 004 • Obbligazzjonijiet tal- professjonist fil- qasam tas- saħħa fir- rigward ta ’ l- għoti tar- riċetta ta ’ Revlimid o Il- ħtieġa li jipprovdi pariri komprensivi lill- pazjenti o Li l- pazjenti għandhom ikunu kapaċi li jkunu konformi mal- ħtiġijiet għall- użu sigur ta ’ Revlimid o Il- ħtieġa li jipprovdi lill- pazjent bil- pamflets edukattivi adattati għall- pazjent u l- kard tal- pazjent • Pariri rilevanti dwar is- sigurtà lill- pazjenti kollha o Deskrizzjoni u mmaniġġjar ta ’ newtropenja u tromboċitopenja li tinkludi rati ta ’ inċidenzi minn studji kliniċi o Deskrizzjoni u mmaniġġjar ta ’ riskju tromboembolitiku li tinkludi rati ta ’ inċidenzi minn studji kliniċi o Użu f’ pazjenti b’ indeboliment tal- fwied u/ jew renali o Rimi ta ’ mediċina mhux meħtieġa o Arranġamenti speċifiċi għall- pajjiż lokali għal riċetta biex jingħata Revlimid o Deskrizzjoni tar- riskju ta ’ ipotirojdiżmu o Spjegazzjoni ta ’ riskju mhux magħruf ta ’ newropatija b’ użu għal żmien fit- tul • Deskrizzjoni tal- PPP u l- kategorizzazzjoni ta ’ pazjenti bbażata fuq is- sess u l- potenzjal li jista ’ jkollhom it- tfal o Algorithm għall- implimentazzjoni tal- PPP o Definizzjoni ta ’ nisa li jista ’ jkollhom tfal (WCBP, Women of ChildBearing Potential) u azzjonijiet li t- tabib għandu jieħu jekk ma jkunx ċert • Pariri dwar is- sigurtà għal nisa ta ’ li jista ’ jkollhom it- tfal o Il- ħtieġa li tiġi evitata l- espożizzjoni tal- fetu o Deskrizzjoni tal- PPP o Il- ħtieġa għal kontraċezzjoni adegwata (anki jekk il- mara jkollha l- amenorrea) u definizzjoni ta ’ kontraċezzjoni adegwata o Kors tat- test tat- tqala Pariri dwar testijiet adattati Qabel tibda l- kura Matul il- kura bbażat fuq il- metodu ta ’ kontraċezzjoni Wara li tintemm il- kura o Il- ħtieġa li twaqqaf Revlimid immedjatament malli jkun hemm suspett ta ’ tqala o Il- ħtieġa li tgħid lit- tabib li jkun qed jipprovdi l- kura immedjatament malli jkun hemm suspett ta ’ tqala • Pariri dwar is- sigurtà għall- irġiel o Il- ħtieġa li tiġi evitata l- espożizzjoni tal- fetu
Educational Brochures for patients
Pamflets edukattivi għall- pazjenti
All patient brochures should contain the following elements: • That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans • That Revlimid may cause neutropenia and thrombocytopenia and the need for regular blood tests • Description of the patient card and its necessity • Disposal of unwanted medicine • National or other applicable specific arrangements for a prescription for Revlimid to be dispensed • That the patient should not give Revlimid to any other person • That the patient should not donate blood • That the patient should tell their doctor about any adverse events
Il- pamflets kollha tal- pazjent għandhom jinkludu l- elementi li ġejjin: • Li lenalidomide hu teratoġeniku fl- annimali u hu mistenni li jkun teratoġeniku fil- bnedmin • Li Revlimid jista ’ jikkawża newtropenja u tromboċitopenja u l- ħtieġa għal testijiet regolari tad- demm • Deskrizzjoni tal- kard tal- pazjent u l- bżonn tagħha • Rimi ta ’ mediċina mhux meħtieġa • Arranġamenti nazzjonali jew oħrajn speċifiċi applikabbli biex jingħata Revlimid wara riċetta • Li l- pazjent m’ għandux jagħti Revlimid lill- ebda persuna oħra • Li l- pazjent m’ għandux jagħti d- demm • Li l- pazjent għandu jgħid lit- tabib tiegħu dwar kwalunkwe avvenimenti avversi
Brochure for women patients with childbearing potential • The need to avoid foetal exposure • Description of the PPP • Need for adequate contraception and definition of adequate contraception • Pregnancy test regime o Before commencing treatment o During treatment, every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment • The need to stop Revlimid immediately upon suspicion of pregnancy • The need to contact their doctor immediately upon suspicion of pregnancy
Pamflet għal pazjenti nisa li jista ’ jkollhom tfal • Il- ħtieġa li tiġi evitata l- espożizzjoni tal- fetu • Deskrizzjoni tal- PPP • Il- ħtieġa għal kontraċezzjoni adegwata u definizzjoni ta ’ kontraċezzjoni adegwata • Kors tat- test tat- tqala o Qabel jibdew l- kura o Matul il- kura kull 4 ġimgħat minbarra f’ każ ta ’ sterilizzazzjoni tat- tubi kkonfermata o Wara li jtemmu il- kura • Il- ħtieġa li jwaqqfu Revlimid immedjatament malli jkun hemm suspett ta ’ tqala • Il- ħtieġa li jikkuntattjaw lit- tabib tagħhom immedjatament malli jkun hemm suspett ta ’ tqala
Brochure for male patients • The need to avoid foetal exposure • The need to use condoms if sexual partner is a WCBP (even if man has had vasectomy) o During Revlimid treatment o For one week following final dose • That the patient should not donate semen • That if his partner becomes pregnant he should inform his treating doctor immediately
Pamflet għall- pazjenti rġiel • Il- ħtieġa li tiġi evitata l- espożizzjoni tal- fetu • Il- ħtieġa li jużaw il- kondoms jekk is- sieħba sesswali hi WCBP (anki jekk ir- raġel kellu vasektomija) o Matul il- kura b’ Revlimid o Għal ġimgħa wara d- doża finali. • Li l- pazjent m’ għandux jagħti semen
65 • OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRA
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 placed on the market.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 5. 1 ippreżentata fil- modulu 1. 8. 1 tal- Applikazzjoni ta ’ l- Awtorizzazzjoni għat - tqegħid fis- suq, tkun implimentata u tkun taħdem qabel ma l- prodott jibda jinbiegħ u waqt li l- prodott jitqiegħed fis- suq.
The MAH commits to perform the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan as agreed in version 8.3 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.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq iwiegħed li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- pjan tal- Farmakoviġilanza kif miftehma f’ verżjoni 8. 3 tal- Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat fil- modulu 1. 8. 2 tal- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- tqegħid fis- suq u kwalunkwe aġġornamenti sussegwenti tal- RMP mifthema mill- 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- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (PSUR) li jmiss.
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 hekk, għandu jkun sottomess RMP aġġornat: • meta wieħed jircievi informazzjoni ġdida li tista ’ teffetwa l- ispeċifikazzjoni tas- Sigurta` kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskji • fi żmien 60 jum minn meta jintlaħaq punt importanti (ta ’ Farmakoviġilanza jew li jnaqqsu r - riskji) • fuq talba tal- EMEA.
66 ANNEX III
74 ANNESS III
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
76 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Revlimid 5 mg hard capsules lenalidomide
Revlimid 5 mg kapsuli iebsin lenalidomide
Each capsule contains 5 mg lenalidomide.
Kull kapsula fiha 5 mg ta ’ lenalidomide.
It contains lactose, anhydrous.
Fih lactose, anhydrous.
See package leaflet, section 2.
Ara l- fuljett ta ’ tagħrif, sezzjoni 2.
21 hard capsules
21 kapsula iebsin
Use only as directed by your doctor.
Uża l- mediċina biss kif jgħidlek it- tabib tiegħek.
Lenalidomide is expected to be harmful to an unborn child.
Lenalidomide hu mistenni li jkun ta ’ ħsara lit- tarbija mhix imwielda.
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
78 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
79 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Revlimid 10 mg hard capsules lenalidomide
Revlimid 10 mg kapsuli iebsin lenalidomide
Each capsule contains 10 mg lenalidomide.
Kull kapsula fiha 10 mg ta ’ lenalidomide.
Do not store above 25°C
Taħżinx f’ temperatura ’ l fuq minn 25ºC.
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
81 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
82 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Revlimid 15 mg hard capsules lenalidomide
Revlimid 15 mg kapsuli iebsin lenalidomide
Each capsule contains 15 mg lenalidomide.
Kull kapsula fiha 15 mg ta ’ lenalidomide.
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
84 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
85 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Revlimid 25 mg hard capsules lenalidomide
Revlimid 25 mg kapsuli iebsin lenalidomide
Each capsule contains 25 mg lenalidomide.
Kull kapsula fiha 25 mg ta ’ lenalidomide.
See package leaflet, see section 2.
Ara l- fuljett ta ’ tagħrif, sezzjoni 2.
21 hard capsule
21 kapsula iebsin
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
87 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
81 PACKAGE LEAFLET:
89 FULJETT TA ’ TAGĦRIF:
Revlimid 5 mg hard capsules Revlimid 10 mg hard capsules Revlimid 15 mg hard capsules Revlimid 25 mg hard capsules lenalidomide
Revlimid 5 mg kapsuli iebsin Revlimid 10 mg kapsuli iebsin Revlimid 15 mg kapsuli iebsin Revlimid 25 mg kapsuli iebsin lenalidomide
Do not pass it on or share it with others.
M’ għandekx tgħaddiha lil persuni oħra.
It
Tista ’
may harm them, even if their symptoms are the same as yours.
tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Revlimid is and what it is used for 2.
X’ inhu Revlimid u għalxiex jintuża 2.
Before you take Revlimid 3.
Qabel ma tieħu Revlimid 3.
How to take Revlimid 4.
Kif għandek tieħu Revlimid 4.
Possible side effects 5 How to store Revlimid 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Revlimid 6.
WHAT REVLIMID IS AND WHAT IT IS USED FOR
X’ INHU REVLIMID U GĦALXIEX JINTUŻA
What Revlimid is Revlimid belongs to a group of medicines called immunomodulatory medicines, which can modify or regulate the functioning of the immune system.
X’ inhu Revlimid Revlimid jappartieni għal grupp ta ’ mediċini msejħa mediċini immunomodulatorji, li jistgħu jimmodifikaw jew jirregolaw kif taħdem is- sistema immuni.
What Revlimid is used for Revlimid in combination with dexamethasone is used to treat adult patients who have been diagnosed with multiple myeloma.
Għalxiex jintuża Revlimid Revlimid flimkien ma ’ dexamethasone jintuża biex jikkura pazjenti adulti li kienu dijanjostikati b’ mjeloma multipla.
Multiple myeloma is a type of blood cancer that affects the white blood cells that produce antibodies.
Mjeloma multipla hi tip ta ’ kanċer tad- demm li jaffettwa ċ- ċelluli bojod tad - demm li jipproduċu l- antikorpi.
BEFORE YOU TAKE REVLIMID
QABEL MA TIEĦU REVLIMID
Follow all of your doctor’s instructions carefully, even if they differ from the general information given in this leaflet.
Segwi l- istruzzjonijiet kollha tat- tabib tiegħek b’ attenzjoni, anki jekk ikunu differenti mill - informazzjoni ġenerali mogħtija f’ dan il- fuljett.
• if you are pregnant or think you may be pregnant or are planning to become pregnant, as Revlimid is expected to be harmful to an unborn child (see section 2, “Take special care with Revlimid” and “Pregnancy”). • if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2 “Take special care with Revlimid” and “Pregnancy”).
TIEĦUX Revlimid • jekk int tqila jew taħseb li int tqila, jew qed tippjana li toħroġ tqila, għax Revlimid hu mistenni li jkun ta ’ ħsara lit- tarbija mhix imwielda (ara sezzjoni 2, “ Oqgħod attent ħafna b’ Revlimid ” u “ Tqala ”). • jekk tista ’ toħroġ tqila, ħlief jekk issegwi l- miżuri kollha neċessarji ta ’ prevenzjoni li ma jħallukx toħroġ tqila (ara sezzjoni 2, “ Oqgħod attent ħafna b’ Revlimid ” u “ Tqala ”).
If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation. • if you are allergic (hypersensitive) to lenalidomide or any of the other ingredients of Revlimid listed in Section 6, “What Revlimid contains”.
Jekk tista ’ toħroġ tqila, it- tabib tiegħek ser jikteb ma ’ kull riċetta, li l- miżuri neċessarji ttieħdu, u ser jagħtik din il- konferma. • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal lenalidomide jew sustanzi oħra ta ’ Revlimid elenkati f’ Sezzjoni 6, “ X’ fih Revlimid ”.
If you think you may be allergic, ask your doctor for advice.
Jekk taħseb li tista’ tkun allerġiku/ a, itlob parir lit- tabib tiegħek.
If any of these apply to you, tell your doctor before you take Revlimid.
Jekk xi waħda minn dawn tapplika għalik, għid lit- tabib tiegħek qabel ma tibda tieħu Revlimid.
82 Take special care with Revlimid Please talk to your doctor in the following situations:
90 Oqgħod attent ħafna b’ Revlimid Jekk jogħġbok kellem lit- tabib tiegħek fis- sitwazzjonijiet li ġejjin:
For women taking Revlimid Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely.
Għal nisa li qed jieħdu Revlimid Qabel tibda l- kura, għandek issaqsi lit- tabib tiegħek jekk tista ’ toħroġ tqila, anki jekk taħseb li dan x’ aktarx li mhux ser iseħħ.
If you are able to become pregnant • you will have pregnancy tests under the supervision of your doctor (before treatment, every 4 weeks during treatment, and 4 weeks after the treatment has finished) except in the case of confirmed tubal sterilisation AND • you must use effective methods of contraception for 4 weeks before starting treatment, during treatment, and until 4 weeks after stopping treatment.
Jekk tista ’ toħroġ tqila • inti ser jkollok testijiet tat- tqala taħt is- superviżjoni tat- tabib tiegħek (qabel tibda l- kura, kull 4 ġimgħat matul il- kura u 4 ġimgħat wara t- tmiem tal- kura) minbarra f’ każ ta ’ sterilizzazzjoni tat- tubi kkonfermata U • inti għandek tuża metodi effettivi ta ’ kontraċezzjoni għal 4 ġimgħat qabel ma tibda l- kura, matul il- kura, u sa 4 ġimgħat wara li twaqqaf il- kura.
Your doctor will advise you on appropriate methods of contraception.
It- tabib tiegħek ser jagħtik parir dwar metodi adattati ta ’ kontraċezzjoni.
For men taking Revlimid It is not known if Revlimid passes into human semen.
Għall- irġiel li qed jieħdu Revlimid Mhux magħruf jekk Revlimid jgħaddix fis- semen uman.
If your female partner is able to become pregnant, and she doesn’t use effective methods of contraception, you must use condoms, during treatment and 1 week after the end of treatment.
Jekk is- sieħba tiegħek tista ’ toħroġ tqila, u hi ma tużax metodi effettivi ta ’ kontraċezzjoni, inti għandek tuża l- kondoms, matul il- kura, u sa ġimgħa wara li tintemm il- kura.
You should not donate semen during treatment and for 1 week after the end of treatment.
Inti m’ għandekx tagħti semen matul il- kura u sa ġimgħa wara li tintemm il - kura.
All patients Before starting the treatment you should tell your doctor if you had blood clots in your veins in the past.
Il- pazjenti kollha Qabel tibda l- kura għandek tgħid lit- tabib tiegħek jekk fil- passat kellek emboli tad- demm (trombożi) fil- vini tiegħek.
During the treatment with Revlimid you have an increased risk of developing blood clots in the veins.
Matul il- kura b’ Revlimid ikollok żieda fir- riskju li tiżviluppa emboli tad- demm fil- vini.
Before and during the treatment with Revlimid you will have regular blood tests as Revlimid may cause a fall in the blood cells that help fight infection and help the blood to clot.
Qabel u matul il- kura b’ Revlimid, inti ser ikollok testijiet regolari tad- demm għax Revlimid jista ’ jikkawża tnaqqis fin- numru ta ’ ċelluli tad- demm li jgħinu biex jiġġieldu l- infezzjoni u jgħinu lid - demm biex jagħqad.
Your doctor should ask you to have a blood test: • before treatment • every week for the first 8 weeks of treatment • at least every month after that.
It- tabib tiegħek għandu jitolbok biex tagħmel test tad- demm: • qabel il- kura • kull ġimgħa għall- ewwel 8 ġimgħat tal- kura • mill- inqas kull xahar wara dak il- perijodu.
Your doctor may adjust your dose of Revlimid or stop your treatment based on the results of your blood tests and on your general condition.
It- tabib tiegħek jista ’ jaġġusta d- doża tiegħek ta ’ Revlimid jew iwaqqaf il- kura tiegħek skond ir - riżultati tat- testijiet tad- demm tiegħek u l- kundizzjoni ġenerali tiegħek.
Before you start treatment you should tell your doctor if you have kidney disease.
Qabel tibda l- kura, għandek tgħid lit- tabib tiegħek jekk għandekx mard renali.
Your doctor may adjust your dose of Revlimid based on this information.
It- tabib tiegħek jista ’ jaġġusta d- doża tiegħek ta ’ Revlimid skond din l- informazzjoni.
You should not donate blood during treatment and for 1 week after the end of treatment.
Inti m’ għandekx tagħti demm matul il- kura u sa ġimgħa wara li tintemm il- kura.
At the end of the treatment you should return all unused capsules to the pharmacist.
Fit- tmiem tal- kura għandek tieħu lura l- kapsuli kollha mhux użati għand l- ispiżjar.
Taking other medicines Please tell your doctor or pharmacist of all other medicines that you are taking or have recently taken, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek dwar il- mediċini l- oħrajn kollha li qiegħed tieħu jew li ħadt dan l- aħħar, anki dawk mingħajr riċetta.
Taking Revlimid with food and drink The Revlimid capsules can be taken either with or without food (see Section 3, “How and when to take the Revlimid capsule”).
Meta tieħu Revlimid ma ’ l- ikel u max- xorb Il- kapsuli ta ’ Revlimid jistgħu jittieħdu ma ’ l- ikel jew mingħajru (ara sezzjoni 3, “ Kif u meta tieħu Revlimid ”).
Pregnancy You must not take Revlimid if you are pregnant, as it is expected to be harmful for an unborn baby.
Tqala M’ għandekx tieħu Revlimid jekk inti tqila, għax dan hu mistenni li jkun ta ’ ħsara lit- tarbija mhix imwielda.
In addition, you must not become pregnant while taking Revlimid.
Flimkien ma ’ dan, inti m’ għandekx toħroġ tqila meta tkun qed tieħu Revlimid.
Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see Section 2, “Take special care with Revlimid”).
Għalhekk, inti għandek tuża metodi effettivi ta ’ kontraċezzjoni jekk inti mara li tista ’ toħroġ tqila (ara sezzjoni 2, “ Oqgħod attent ħafna b’ Revlimid ”).
83 If you do become pregnant during the treatment with Revlimid, you must stop the treatment and inform your doctor immediately.
91 Jekk inti toħroġ tqila matul il- kura b’ Revlimid, għandek twaqqaf il- kura u tinforma lit- tabib tiegħek immedjatament.
For men taking Revlimid, please see section 2 “Take special care with Revlimid”.
Għall- irġiel li qed jieħdu Revlimid, jekk jogħġbok ara sezzjoni 2 “ Oqgħod attent ħafna b’ Revlimid ”.
If your partner becomes pregnant whilst you are taking lenalidomide, you should inform your doctor immediately.
Jekk is- sieħba tiegħek toħroġ tqila meta tkun qed tieħu lenalidomide, għandek tinforma lit- tabib tiegħek immedjatament.
It is recommended that your partner seeks medical advice.
Hu rakkomandat li s- sieħba tiegħek tfittex parir mediku.
Breast-feeding You should not breastfeed when taking Revlimid, as it is not known if Revlimid passes into human milk.
Treddigħ M’ għandekx tredda ’ waqt li tkun qed tieħu Revlimid, għax mhux magħruf jekk Revlimid jgħaddix fil - ħalib tal- bniedem.
Do not drive or operate machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.
Sewqan u tħaddim ta ’ magni Issuqx jew tħaddem magni jekk ikollok effetti sekondarji bħal sturdament, għeja, ngħas jew vista mċajpra.
Important information about some of the ingredients of Revlimid Revlimid contains lactose (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Revlimid Revlimid fih lactose (tip ta ’ zokkor).
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Revlimid.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu Revlimid.
HOW TO TAKE REVLIMID
KIF GĦANDEK TIEĦU REVLIMID
Revlimid is taken in combination with dexamethasone.
Revlimid jittieħed flimkien ma ’ dexamethasone.
Always take Revlimid and dexamethasone exactly as your doctor has told you.
Dejjem għandek tieħu Revlimid u dexamethasone skond il- parir eżatt tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju..
You should refer to the package leaflet for dexamethasone for further information on its use and effects.
Għandek tirreferi għall- fuljett ta ’ tagħrif għal dexamethasone għal informazzjoni addizzjonali dwar l- użu u l- effetti tiegħu.
Revlimid dosage The usual starting dose is 25 mg once per day.
Revlimid jittieħed f’ ċikli tal- kura, u kull ċiklu jdum 28 jum.
Revlimid is taken in treatment cycles, each cycle lasting 28 days.
F’ jiem 22- 28:
Treatment cycle: • On days 1-21: take 25 mg of Revlimid once per day • On days 22-28: do NOT take Revlimid After completing each cycle, start a new one.
ħu 25 mg ta ’ Revlimid darba kuljum TIEĦUX Revlimid
Your doctor may adjust your dose of Revlimid or stop your treatment based on the results of your blood tests and on your general condition (see Section 2, Take special care with Revlimid”).
It- tabib tiegħek jista ’ jaġġusta d- doża tiegħek ta ’ Revlimid jew iwaqqaf il- kura tiegħek, skond ir - riżultati tat- testijiet tad- demm tiegħek u l- kundizzjoni ġenerali tiegħek (ara sezzjoni 2, “ Oqgħod attent ħafna b’ Revlimid ”).
Dexamethasone dosage The usual starting dose is 40 mg once per day.
Id- dożaġġ ta ’ dexamethasone Id- doża normali tal- bidu hi ta ’ 40 mg darba kuljum.
Dexamethasone is also taken in treatment cycles, each cycle lasting 28 days.
F’ jiem 21- 28:
First 4 treatment cycles: • On days 1-4, 9-12 and 17-20: take 40 mg dexamethasone once per day • On days 21-28: do NOT take dexamethasone
ħu 40 mg ta ’ dexamethasone darba kuljum TIEĦUX dexamethasone
Following treatment cycles: • On days 1-4: take 40 mg dexamethasone once per day • On days 5-28: do NOT take dexamethasone After completing each cycle, start a new one.
ħu 40 mg ta ’ dexamethasone darba kuljum TIEĦUX dexamethasone
How and when to take Revlimid You should swallow the Revlimid capsules whole, preferably with water, once a day.
Kif u meta tieħu Revlimid Għandek tibla ’ l- kapsuli Revlimid sħaħ, preferibbilment ma ’ l- ilma, darba kuljum.
Do not break or chew the capsules.
Taqsamx u tomghodx il- kapsuli.
The Revlimid capsules can be taken either with or without food.
Il- kapsuli Revlimid jistgħu jittieħdu ma ’ l- ikel jew mingħajr l- ikel.
You should take Revlimid at about the same time each day.
92 Għandek tieħu Revlimid bejn wieħed u ieħor fl- istess ħin kuljum.
84 Duration of the treatment with Revlimid Revlimid is taken in treatment cycles, each cycle lasting 28 days (see above “Dosage”).
It- tul ta ’ żmien tal- kura b’ Revlimid Revlimid jittieħed f’ ċikli tal- kura, u kull ċiklu jdum 28 jum (ara hawn fuq “ Id- dożaġġ ta ’ Revlimid ”).
You should continue the cycles of treatment until your doctor tells you to stop.
Għandek tkompli ċ- ċikli tal- kura sakemm it- tabib tiegħek jgħidlek biex tieqaf.
If you take more Revlimid than you should If you take more Revlimid than was prescribed, tell your doctor immediately.
Jekk tieħu Revlimid aktar milli suppost Jekk tieħu iktar Revlimid minn dak li hemm fuq ir- riċetta, għid it- tabib tiegħek immedjatament.
If you forget to take Revlimid If you forget to take Revlimid at your regular time and • less than 12 hours have passed: take your capsule immediately. • more than 12 hours have passed: do not take your capsule.
Jekk tinsa tieħu Revlimid Jekk tinsa tieħu Revlimid fil- ħin regolari tiegħek u • jkunu għaddew inqas minn 12- il siegħa: ħu l- kapsula tiegħek immedjatament. • jkunu għaddew iktar minn 12- il siegħa: tieħux il- kapsula tiegħek.
Take your next capsule at the usual time the next day.
Ħu l- kapsula li jmiss fil- ħin normali l- għada.
If you have any further questions on the use of Revlimid, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ Revlimid, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Revlimid can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Revlimid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of side effects is classified into the following categories:
Il- frekwenza ta ’ l- effetti sekondarji hi kklassifikata fil- kategoriji li ġejjin:
Very common Common Uncommon Rare
Komuni ħafna Komuni Mhux komuni
In more than 1 in 10 patients In more than 1 in 100 patients, but less than 1 in 10 In more than 1 in 1,000 patients, but less than 1 in 100 In more than 1 in 10,000 patients, but less than 1 in 1,000
F’ iktar minn 1 f’ kull 10 pazjenti F’ iktar minn 1 f’ kull 100 pazjent, iżda f’ inqas minn 1 f’ kull 10 pazjenti F’ iktar minn 1 f’ kull 1, 000 pazjent, iżda f’ inqas minn 1 f’ kull 100 pazjent
It is important to note that Revlimid may reduce the number of white blood cells that fight infection and also the blood cells which help the blood to clot (platelets).
Hu importanti li tinnota li Revlimid jista ’ jnaqqas in- numru ta ’ ċelluli bojod tad- demm li jiġġieldu l - infezzjoni u wkoll ċelluli tad- demm li jgħinu lid- demm biex jagħqad (plejtlits).
Revlimid may also cause blood clots in the veins (thrombosis).
Revlimid jista ’ wkoll jikkawża emboli tad- demm fil- vini (trombożi).
Therefore you must tell your doctor immediately if you experience: • any fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection • any bleeding or bruising in the absence of injury • any chest or leg pain • any shortness of breath.
Għalhekk inti għandek tgħid lit- tabib tiegħek immedjatament jekk inti jkollok: • kwalunkwe deni, tertir ta ’ bard, uġigħ fil- griżmejn, sogħla, ulċeri tal- ħalq jew kwalunkwe sintomi oħrajn ta ’ infezzjoni • kwalunkwe ħruġ ta ’ demm jew tbenġil fl- assenza ta ’ korriment • kwalunkwe uġigħ fis- sider jew fir- riġlejn • kwalunkwe qtugħ ta ’ nifs.
Very common side effects are given below.
Effetti sekondarji komuni ħafna huma elenkati hawn taħt.
You should consult your doctor if you experience any of these: • A fall in the number of white blood cells (the cells that fight infection), platelets (the cells that help the blood to clot, which may lead to bleeding disorders) and red blood cells (anaemia leading to tiredness and weakness) • Constipation, diarrhoea, nausea, increase and decrease in weight, rash, sleep disturbance, muscle cramps and muscle weakness, tiredness, swelling of the peripheries.
Għandek tikkonsulta lit- tabib tiegħek jekk jkollok xi sintomu minn dawn: • Tnaqqis fin- numru ta ’ ċelluli bojod tad- demm (iċ- ċelluli li jiġġieldu l- infezzjoni), plejtlits (iċ - ċelluli li jgħinu lid- demm biex jagħqad, li jista ’ jwassal għal disturbi ta ’ ħruġ ta ’ demm) u ċelluli ħomor tad- demm (anemija li twassal għal għeja u dgħjufija) • Stitikezza, dijarea, tqallih, żieda u tnaqqis fil- piż, raxx, disturb fl- irqad, bugħawwieġ fil- muskoli u dgħjufija fil- muskoli, għeja, nefħa tal- periferiji.
Common side effects are given below.
Effetti sekondarji komuni huma elenkati hawn taħt.
You should consult your doctor if you experience any of these: • Infections of all types, fever and flu like symptoms • Loss of appetite, retention of fluid, dehydration, raised blood sugar levels, changes to the calcium, potassium or magnesium in the blood • Confusion, seeing or hearing things that do not exist (hallucinations), depression, aggression, agitation, mood changes, anxiety, nervousness, irritability • Stroke ,paralysis, fainting, memory disturbance, numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, headache, tremor, sleepiness, taste disturbance or taste loss, giddiness • Blurred or reduced vision, cataract, increased tear production • Leg pain (which could be a symptom of thrombosis), increased blood pressure or a fall in blood pressure especially on standing (which may lead to dizziness or fainting when standing),
Għandek tikkonsulta lit- tabib tiegħek jekk jkollok xi sintomu minn dawn: • Infezzjonijiet ta ’ kull tip, deni u sintomi bħal dawk ta ’ l- influwenza. • Telf t’ aptit, żamma ta ’ fluwidu, deidrazzjoni, żieda fil- livelli taz- zokkor, bidliet fil- livelli tal - calcium, potassium jew magnesium fid- demm • Konfużjoni, tara jew tisma ’ affarijiet li mhumiex reali (alluċinazzjonijiet), dipressjoni, aggressjoni, aġitazzjoni, tibdil fil- burdata, ansjetà, nervożità, irritabilità
85 flushing, chest pain or shortness of breath (which may be a symptom of blood clots in the lungs), irregular heart beat, palpitations • Cough, hoarseness, hiccoughs, nosebleed • Vomiting, indigestion, abdominal pain, abdominal swelling, sore inflamed mouth, dry mouth, excessive wind, blood in the stools • Swelling of the face, dry skin, itching, redness of the skin, inflammation of the hair follicles, increased pigmentation of skin, increased sweating, hair loss, bruising • Muscle, bone, back, limb or joint pains or weakness, general feeling of unwellness, generalised swelling • Production of much more or much less urine than usual (which may be a symptom of kidney failure), passing blood in the urine • Difficulty in obtaining an erection, breast enlargement, nipple pain, abnormal menstruation.
93 • Puplesija, paralisi, ħassħażin, disturbi fil- memorja, tmewwit, tnemnim jew sensazzjoni ta ’ ħruq fil- ġilda, uġigħ fl- idejn jew fis- saqajn, sturdament, uġigħ ta ’ ras, rogħda, rqad, disturb fit - togħma jew telf fis- sens tat- togħma, mejt • Vista mċajpra jew imnaqqsa, katarretti, żieda fil- produzzjoni tad- dmugħ • Uġigħ fir- riġlejn; (li jista ’ jkun sintomu ta ’ trombożi), żieda fil- pressjoni tad- demm jew tnaqqis fil- pressjoni tad- demm, speċjalment meta tkun bilwieqfa (li jista ’ jwassal għal sturdament jew ħass ħażin meta tkun bilwieqfa), fwawar, uġigħ fis- sider jew qtugħ ta ’ nifs (li jista ’ jkun sintomu ta ’ emboli tad- demm fil- pulmuni), taħbit tal- qalb irregolari, palpitazzjonijiet • Sogħla, ħanqa, sulluzzu, tinfaraġ • Rimettar, indiġestjoni, uġigħ addominali, nefħa fiż- żaqq, ħalq muġugħ u infjammat, ħalq xott, gass eċċessiv, demm fl- ippurgar • Nefħa tal- wiċċ, ġilda xotta, ħakk, ħmura tal- ġilda, infjammazzjoni tal- follikuli tax- xagħar, żieda fil- kulur tal- ġilda, żieda fl- għaraq, telf ta ’ xagħar, tbenġil • Uġigħ jew dgħjufija fil- muskoli, fl- għadam, fid- dahar, fir- riġlejn/ dirgħajn jew uġigħ fil- gogi, tħoss sensazzjoni ta ’ skomfort ġenerali, nefħa ġeneralizzata • Produzzjoni ta ’ ħafna iktar jew ħafna inqas awrina mis- soltu (li jista ’ jkun sintomu ta ’ kollass renali), ikun hemm id- demm ma ’ l- awrina • Diffikultà biex ikollok erezzjoni, tkabbir fis- sider, uġigħ f’ ras il- beżżula, mestrwazzjoni anormali.
Uncommon side effects are given below.
Effetti sekondarji mhux komuni huma elenkati hawn taħt.
Rare side effects are given below.
Effetti sekondarji rari huma elenkati hawn taħt.
You should consult your doctor if you experience any of these: • Serious allergic reaction that may begin as rash in one area but spread with extensive loss of skin over the whole body
Għandek tikkonsulta lit- tabib tiegħek jekk jkollok xi sintomu minn dawn: • Reazzjoni allerġika serja li tista ’ tibda bħala raxx f’ żona waħda iżda tinfirex b’ telf estensiv ta ’ ġilda madwar il- ġisem kollu
If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
94 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE REVLIMID
KIF TAĦŻEN REVLIMID
• Keep out of the reach and sight of children. • Do not use Revlimid after the expiry date, which is stated on the blister after “EXP”.
• Żomm Revlimid fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax Revlimid wara d- data ta ’ skadenza, li tidher fuq il- folja wara “ EXP ”.
The expiry date refers to the last day of that month. • Do not store above 25 C • Do not use any pack that is damaged or shows signs of tampering.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar. • Taħżinx f’ temperatura ’ l fuq minn 25ºC. • Tuża l- ebda pakkett li jkollu l- ħsara jew li jkun fih sinjali ta ’ tbagħbis.
All unused Revlimid capsules should be returned to the pharmacist.
Il- kapsuli kollha mhux użati ta ’ Revlimid għandhom jittieħdu lura għand l- ispiżjar.
What Revlimid contains
X’ fih Revlimid
Revlimid 5 mg hard capsules: • The active substance is lenalidomide.
Revlimid 5 mg kapsuli iebsin: • Is- sustanza attiva hi lenalidomide.
Each capsule contains 5 mg of lenalidomide. • The other ingredients are:
Kull kapsula fiha 5 mg ta ’ lenalidomide. • Is- sustanzi l- oħra huma:
capsule contents: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate
il- kontenut tal- kapsula: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium u magnesium stearate
capsule shell: gelatine and titanium dioxide (E171) printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).
qoxra tal- kapsula: gelatin u titanium dioxide (E171) linka ta ’ l- istampar: shellac, propylene glycol, potassium hydroxide u black iron oxide (E172).
Revlimid 10 mg hard capsules: • The active substance is lenalidomide.
Revlimid 10 mg kapsuli iebsin: • Is- sustanza attiva hi lenalidomide.
Each capsule contains 10 mg of lenalidomide. • The other ingredients are:
Kull kapsula fiha 10 mg ta ’ lenalidomide. • Is- sustanza l- oħra huma:
capsule shell: gelatine, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide (E172)
qoxra tal- kapsula: gelatin, titanium dioxide (E171), indigo carmine (E132) u yellow iron oxide (E172)
printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).
linka ta ’ l- istampar: shellac, propylene glycol, potassium hydroxide u black iron oxide (E172).
Revlimid 15 mg hard capsules: • The active substance is lenalidomide.
Revlimid 15 mg kapsuli iebsin: • Is- sustanza attiva hi lenalidomide.
Each capsule contains 15 mg of lenalidomide. • The other ingredients are:
Kull kapsula fiha 15 mg ta ’ lenalidomide. • Is- sustanzi l- oħra huma:
-
- il- kontenut tal- kapsula: anhydrous lactose, microcrystalline cellulose, croscarmellose
capsule contents: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate
sodium u magnesium stearate