qanastek/EMEA-V3 huggingface dataset:
Revatio brings down pulmonary blood pressure by widening the blood vessels in the lungs.
Revatio ibaxxi il- pressjoni għolja fil- pulmun billi jwessa ’ l- kanali tad- demm fil- pulmun.
Revatio is used to treat pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs).
Revatio jintuża għat- trattament ta ’ pressjoni arterjali pulmonari għolja (pressjoni għolja fil- kanali tad- demm fil- pulmun).
BEFORE YOU TAKE REVATIO
QABEL MA TIEĦU REVATIO
Do not take Revatio
Tieħux Revatio
If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Revatio.
Jekk inti allerġiku/ a (tbati minn sensittivita eċċessiva) għal sildenafil jew sustanzi oħra ta ’ Revatio.
-
- Jekk inti qed tieħu mediċini li fihom nitrati, jew donaturi ta ’ nitric oxide bħal amyl nitrite
These medicines are often given for relief of angina pectoris (or “ chest pain”).
Dawn il- mediċini jingħataw spiss biex itaffu l- anġina pectoris (jew “ uġigħ tas - sider ”).
Revatio can cause a serious increase in the effects of these medicines.
Revatio jista ’ jżied b’ mod serju l- effetti ta ’ dawn il- mediċini.
Tell your doctor if you are taking any of these medicines.
Għid lit- tabib tiegħek jekk inti qed tieħu xi waħda minn dawn il- mediċini.
If you are not certain, ask your doctor or pharmacist.
Jekk inti m’ intix ċert, staqsi lill- ispiżjar jew lit- tabib tiegħek.
-
- Jekk inti dan l- aħħar kellek attakk ta ’ puplesija jew attakk tal- qalb jew jekk għandek mard serju
If you have recently had a stroke, a heart attack or if you have severe liver disease or low blood pressure (< 90/ 50 mmHg).
fil- fwied jew jekk inti għandek pressjoni baxxa (< 90/ 50 mmHg).
-
- Jekk qed tieħu xi mediċina li fiha ketoconazole jew itraconazole (biex tittratta infezzjonijiet
If you are taking a medicine containing ketoconazole or itraconazole (to treat fungal infections) or containing ritonavir (for HIV).
fungali) jew li fiha ritonavir (għal HIV).
- If you have ever had loss of vision because of non-arteritic anterior ischaemic optic neuropathy
- Jekk qatt tlift il- vista minħabba newropatija anterjuri iskimika, mhux arteritika tal- għajn
Take special care with Revatio
Oqgħod attent ħafna b’ Revatio
Tell your doctor
Għid lit- tabib tiegħek:
- If you have a severe heart problem.
- Jekk inti għandek marda serja tal- qalb
- If you have Retinitis pigmentosa (a rare inherited eye disease).
- Jekk inti għandek Retinitis pigmentosa (marda rari ta ’ l- għajnejn ereditarja).
- If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood
- Jekk inti għandek anemija tas- sickle cell (abnormalità taċ- ċelloli ħomor tad- demm), lewkimja
cells), multiple myeloma (cancer of bone marrow), or any disease or deformity of the penis.
(kanċer taċ- celloli tad- demm), multiple myeloma (kanċer tal- mudullun) jew xi marda jew deformità tal- pene tiegħek.
- If you currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems
- jekk fil- preżent inti għandek ulċera fl- istonku, jew mard ta ’ tnixxija tad- demm (bħal emofilja)
with nose bleeds.
jew problemi ta ’ fsada fl- imnieħer.
- If your disease is due to a blocked or narrow vein in the lungs rather than a blocked or narrow
- Jekk il- marda tiegħek hija kkawżata minn vina imblukkata jew dejqa fil- pulmun u mhux arterja
artery.
imblukkata jew dejqa fil- pulmun.
- If you experience sudden decrease or loss of vision, stop taking Revatio and contact your
- jekk għall- għarrieda jkollok tnaqqis fil- vista jew titlef il- vista, tieħux iktar Revatio u kellem lit -
doctor immediately.
tabib tiegħek mill- ewwel.
Special considerations for children and adolescents Revatio should not be given to children and adolescents under the age of 18.
Konsiderazzjonijiet speċjali għat- tfal u adolexxenti Revatio m’ għandux jingħata lil tfal u adolexxenti taħt l- età ta ’ 18- il sena.
Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Konsiderazzjoni speċjali għall- pazjenti bi problemi fil- kliewi jew fil- fwied Inti għandek tgħid lit- tabib tiegħek jekk inti għandek problemi tal- kliewi jew tal- fwied għax id- doża tiegħek jista ’ jkollha bżonn aġġustament.
If you are taking other therapies for pulmonary hypertension ask your doctor or pharmacist for advice before taking Revatio.
Jekk qed tieħu xi terapiji oħra għal pressjoni għolja fil- pulmun staqsi lit- tabib jew lill- ispiżjar tiegħek għall- parir qabel ma ’ tieħu Revatio.
If you are taking medicines that inhibit blood clotting (for example warfarin) please inform your doctor or pharmacist before taking Revatio.
Jekk qed tieħu mediċini li jimpedixxu d- demm milli jagħqad (per eżempju warfarin) jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek qabel ma ’ tieħu Revatio.
If you are taking medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), ask your doctor or pharmacist for advice before taking Revatio, as your dose may need to be adjusted.
Jekk qed tieħu mediċini li fihom erythromycin, clarithromycin, telithromycin (dawn huma antibijotiċi li jintużaw għat- trattament ta ’ ċertu infezzjonijiet batterjali), saquinavir (għal HIV) jew nefazodone (għal dipressjoni mentali), staqsi lit- tabib jew spiżjar tiegħek għal parir qabel ma tieħu Revatio għax jista ’ jkun li d- doża tiegħek ikollha bżonn xi aġġustament.
If you are taking medicines containing ketoconazole or itraconazole to treat fungal infections you should not take Revatio.
Jekk qed tieħu mediċini li fihom ketoconazole jew itraconazole għat- trattament ta ’ infezzjonijiet fungali, ma tistax tieħu Revatio.
Revatio may cause a serious increase in the effects of medicines called nitrates and nitric oxide donors such as amyl nitrate (“ poppers”).
Revatio jista ’ jikkawża żidiet serji fl- effett tan- nitrates jew donaturi ta ’ nitric oxide bħal amylnitrate (poppers).
These medicines are often used for the relief of angina pectoris (or “ chest pain”).
Dawn il- medicini jintużaw ħafna għas- serħan minn angina pectoris (jew “ uġigħ fis- sider ”).
You should not take Revatio if you are taking these medicines.
Ma tistax tieħu Revatio jekk qed tieħu dawn il- mediċini.
If you are taking ritonavir therapy for the treatment of HIV, you should not take Revatio.
Jekk qiegħed fuq terapija ta ’ ritonavir għat- trattament ta ’ l- HIV, ma tistax tieħu Revatio.
If you are taking alpha-blocker therapy for the treatment of high blood pressure or prostate problems, ask your doctor or pharmacist for advice before taking Revatio.
Jekk qed tieħu xi alpha- blockers għat- trattament ta ’ pressjoni għolja jew problemi fil- prostata, staqsi lit- tabib jew lill- ispiżjar tiegħek għal- parir qabel ma tieħu Revatio.
Taking Revatio with food and drink Revatio can be taken with or without food.
Meta tieħu Revatio ma ’ l- ikel u max- xorb Revatio jista jittieħed kemm ma ’ l- ikel kif ukoll mingħajr ikel.
Pregnancy and breast feeding If you are pregnant, or think you might be pregnant, ask your doctor or pharmacist for advice before taking Revatio.
Tqala u Treddigħ Jekk inti tqila, jew qed taħseb biex toħroġ tqila, staqsi lit- tabib jew lill- ispiżjar tiegħek għal parir qabel ma tieħu Revatio.
Revatio should not be used during pregnancy unless strictly necessary.
Revatio m' għandux jingħata waqt it- tqala għajr jekk ikun meħtieġ b' mod ċar.
Stop breast feeding when you start Revatio treatment.
Waqqaf it- treddigħ meta tibda trattament b’ Revatio.
Revatio should not be given to women who are breast feeding since it is not known if the medicine passes into the breast milk.
Revatio m’ għandux jingħata lil nisa li jkunu qed jreddgħu għax m’ huwiex magħruf jekk il- mediċina tgħaddix fil- ħalib uman.
Driving and using machines Revatio can cause dizziness and can affect vision.
Revatio jista ’ jikkawża sturdament u effetti fuq il- vista.
You should be aware of how you react to the medicinal product before you drive or use machinery.
Inti għandek tkun konxju ta ’ kif inti tirreaġġixxi għall- prodott mediċinali qabel ma ssuq jew tħaddem xi makkinarju.
24 Important information about some of the ingredients of Revatio If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Revatio Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, għandek tavża lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE REVATIO
KIF GĦANDEK TIEĦU REVATIO
Always take Revatio exactly as your doctor has told you.
25 Dejjem għandek tieħu Revatio eżattament skond il- parir tat- tabib.
The recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food.
Id- doża li ssoltu tingħata hija 20 mg tliet darbiet kuljum (meħudin minn 6 sa 8 sigħat ’ il bogħod minn xulxin) ma ’ l- ikel jew mhux ma ’ l- ikel.
If you take more Revatio than you should You should not take more tablets than your doctor tells you to.
Jekk tieħu Revatio aktar milli suppost M’ għandekx tieħu aktar pilloli milli jgħidlek it- tabib.
If you take more tablets than you have been told to take contact your doctor.
Jekk tieħu aktar pilloli milli qalulek tieħu, ikkuntattja lit- tabib tiegħek.
If you forget to take Revatio
Jekk tinsa tieħu Revatio
If you forget to take Revatio, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Jekk tinsa tieħu Revatio, ħu doża malli tiftakar, imbagħad kompli ħu l- pilloli tiegħek fil- ħinijiet normali.
If you stop taking Revatio Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse.
Jekk tieqaf tieħu Revatio Jekk twaqqaf it- trattament tiegħek b’ Revatio f’ daqqa, dan jista ’ jirriżulta f’ aggravar tas- sintomi.
Do not stop taking Revatio unless your doctor tells you to.
Ma għandekx tieqaf tieħu Revatio sakemm ma jgħidlekx biex tagħmel hekk it- tabib.
Your doctor may tell you to reduce the dose over a few days before stopping completely.
It- tabib tiegħek jista ’ jgħidlek biex tnaqqas id- doża fuq ftit jiem qabel ma twaqqaf Revatio għal kollox.
Like all medicines, Revatio can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Revatio jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In clinical trials side effects reported very commonly (seen in more than 1 in 10 patients) were headache, facial flushing, indigestion, diarrhoea and limb pain.
Fi provi kliniċi, effetti sekondarji rrapportati komuni ħafna (jidhru f’ aktar minn 1 minn kull 10 pazjenti) kienu uġigħ ta ’ ras, ħmurija fil- wiċċ, indiġestjoni, dijarea u uġigħ fid- dirgħajn jew fis- saqajn.
Other side effects reported commonly (seen in less than 1 in 10 but more than 1 in 100 patients) included: infection under the skin, flu-like symptoms, sinusitis, anaemia, fluid retention, difficulty sleeping, anxiety, migraine, tremor, pins and needles, burning sensation, reduced skin sensation, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes / red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature.
Effetti sekondarji oħra rrapportati b’ mod komuni (jidhru f’ inqas minn 1 minn kull 10 pazjenti iżda f’ aktar minn 1 minn kull 100 pazjent) inkludew: infezzjoni taħt il- ġilda, sintomi bħal ta ’ l- influwenza, sinusite, anemija, żamma ta ’ fluwidi, diffikultà fl- irqad, ansjetà, emikranja, rogħda, irqad ta ’ partijiet tal- ġisem (tingiż), sensazzjoni ta ’ ħruq, telf fis- sensibbiltà fil- ġilda, demm fuq wara ta ’ l- għajn, effetti fuq il- vista, vista mċajpra u sensittività għad- dawl, effetti fuq il- vista tal- kuluri, irritazzjoni ta ’ l- għajn, għajnejn ħomor, sturdament, bronkite, fsada fl- imnieħer, flisjoni, sogħla, konġestjoni fl- imnieħer, infjammazzjoni ta ’ l- istonku, gastro- enterite, ħruq ta ’ stonku, murliti, gass fl- istonku, ħalq xott, ħmurija tal- ġilda, għaraq bil- lejl, uġigħ muskolari, uġigħ tad- dahar u temperatura għolja tal- ġisem.
Other side effects reported less commonly (seen in less than 1 in 100 but more than 1 in 1000 patients) included: reduced sharpness of vision, double vision, abnormal sensation in the eye and breast enlargement in men.
Effetti sekondarji oħra rrapportati b’ mod inqas komuni (jidhru f’ inqas minn 1 minn kull 100 pazjent iżda f’ aktar minn 1 minn kull 1000 pazjent) inkludew, tnaqqis fl- akutezza fil- vista, vista ’ doppja, sensazzjoni mhux normali ta ’ l- għajn u tkabbir tas- sider fl- irġiel.
Skin rash has also been reported.
Ġie rrapportat ukoll raxx tal- ġilda.
Sudden decrease or loss of hearing has been reported.
Tnaqqis f’ daqqa jew telf ta ’ smigħ ġew irrappurtati.
Revatio contains the same active substance, sildenafil, as used in Viagra that is used to treat men with male erectile dysfunction (MED).
Revatio fih is- sustanza attiva, sildenafil, kif użata f’ Viagra li tintuża biex tikkura rġiel b’ disturbi fl - erezzjoni fl- irġiel (MED).
Sildenafil belongs to a class of medicine called phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil jifforma parti minn klassi ta ’ mediċini msejħa inibituri ta ’ phosphodiesterase type 5 (PDE5).
When used to treat MED, the following visual side effects have been reported with PDE5 inhibitors, including sildenafil: partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.
Meta użat biex jittratta MED, ġew irrapportati l- effetti sekondarji li ġejjin b’ inibituri PDE5, inkluż sildenafil: tnaqqis jew telf parzjali, f’ daqqa, temporanju, jew permanenti fil- vista f’ għajn waħda jew fiż- żewġ għajnejn.
25 Prolonged and sometimes painful erections have been reported after taking sildenafil.
Ġew rappurtati erezzjonijiet prolongati u kultant bl- uġigħ wara li ttieħed sildenafil.
If you have such an erection, which lasts continuously for more than 4 hours, you should contact a doctor immediately.
Jekk ikollok erezzjoni kontinwa bħal din għal iktar minn 4 sigħat, għandek tikkuntattja minnufih lil tabib.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
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 REVATIO
KIF TAĦŻEN REVATIO
Do not use Revatio after the expiry date which is stated on the carton.
26 Tużax Revatio wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Do not store above 30OC.
Taħżinx f’ temperatura ’ l fuq minn 30OC.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali, sabiex tilqa ’ mill- umidità.
What Revatio contains
X’ fih Revatio
- The active substance is sildenafil.
- Is- sustanza attiva hi s- sildenafil.
Each tablet contains 20 mg of sildenafil (as the citrate).
Kull pillola fiha 20 mg ta ’ sildenafil (bħala citrate).
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
Qalba tal- pillola: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate, glycerol triacetate
Kisja b’ rita: hypromellose, titanium dioxide (E171), lactose monohydrate, glycerol triacetate
What Revatio looks like and contents of the pack Revatio film-coated tablets are white and round in shape.
Id- dehra ta ’ Revatio u l- kontenuti tal- pakkett Revatio pilloli miksijin b’ rita huma bojod u tondi.
The tablets are marked with “ PFIZER” on one side and “ RVT 20” on the other.
Il- pilloli huma mmarkati bi “ PFIZER ” fuq naħa u b ’ “ RVT 20 ” fuq in- naħa l- oħra.
The tablets are provided in blister packs containing 90 tablets (15 tablets per blister strip).
Il- pilloli huma pprovduti f’ pakketti ta ’ folji li fihom 90 pillola (15- il pillola kull folja).
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni Għat- Tqegħid fis- Suq u l- Manifattur
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.
Pfizer Limited, Sandwich, Kent, CT13 9NJ, Ir- Renju Unit.
Pfizer PGM, Zone Industrielle, 29 route des Industries, 37530 Poce-sur-Cisse, France.
Pfizer PGM, Zone Industrielle, 29 route des Industries, 37530 Poce- sur- Cisse, Franza.
26 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
27 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
България Пфайзер Люксембург САРЛ, Клон България Тел.: +359 2 970 4333
България Пфайзер Люксембург САРЛ, Клон България Тел.: +359 2 970 43 33
27 Κύπρος GEO.
28 Κύπρος GEO.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
There are also links to other website about rare diseases and treatments.
Hemm ukoll links għal websites oħra dwar mard rari u kura.
1 • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri jridu jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir- rigward ta ’ l - użu mingħajr periklu u effettiv tal- prodott mediċinali deskritti hawn taħt huma implimentati:
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare system 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.
L- iStati Membri għandhom jiftehmu dwar id- dettalji ta ’ sistema ta ’ distribuzzjoni kkontrollata ma ’ D- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- suq skond regolamenti nazzjonali u sistema ta ’ qasam tas- saħħa u jridu jimplimentaw programm bħal dan b’ mod nazzjonali biex jiżguraw 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 Member States shall ensure that the MAH implements a pregnancy prevention programme (PPP) within their territory.
L- Istati Membri għandhom jiżguraw li D- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- suq jimplimenta Programm tal- Prevenzjoni tat- Tqala (PPP, Pregnancy Prevention Programm) ġewwa t- territorju tagħhom.
Details of the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Id- dettalji tal- PPP għandhom jiġu miftehma ma ’ l- Awtoritajiet Kompetenti Nazzjonali f’ kull Stat Membru u lesti qabel it- tqegħid fis- suq tal- prodott.
The Member States should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the MAH and ensure that the materials contain the key elements as described below.
L- Istati Membri għandhom jaqblu dwar il- kliem finali tal - Komunikazzjoni Diretta tal - Professjonisti fil- Qasam tas- Saħħa u l- kontenut tal- pakkett ta ’ tagħrif għat- tobba ma ’ D- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- suq u jiżguraw li l- materjali fihom l- elementi essenzjali kif deskritti hawn taħt.
The Member States should agree the local implementation of the patient card system.
L- Istati Membri għandhom jaqblu dwar l- implimentazzjoni lokali tas- sistema tal- kard tal- pazjent.
The Member States should also agree with the MAH 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
L- Istati Membri għandhom jaqblu ukoll ma ’ D- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis - suq 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 to be included
Elementi essenzjali li għandhom jiddahhlu
Direct Healthcare Professional Communication
Komunikazzjoni Diretta tal- Professjonisti fil- Qasam tas- Saħħa
The Direct Healthcare Professional Communication shall consist of two parts: • A core text as agreed by the CHMP. • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o To ensure that all appropriate measures have been performed prior to Revlimid being dispensed
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
The Educational Healthcare Professional’ s Kit
Il- Kitt Edukattiv tal- Professjonist fil- Qasam tas- Saħħa
The Educational Health Care Professional’ s Kit shall contain the following elements: • Brief background on lenalidomide and its licensed indication • Posology • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans including a summary of the interim results of study CC-5013-TOX-004 • Obligations of the health care professional in relation to the prescribing of Revlimid
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
The Educational brochures for patients should be of 3 types: • Brochure for women patients of childbearing potential and their partners • Brochure for women patients who are not of childbearing potential • Brochure for male patients
Il- pamflets edukattivi għall- pazjenti għandhom ikunu ta ’ 3 tipi: • Pamflet għal pazjenti nisa li jista ’ jkollhom tfal u s- sħab tagħhom • Pamflet għal pazjenti nisa li ma jistax ikollhom tfal • Pamflet għall- pazjenti rġiel
3 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
The following information should also be provided in the appropriate brochure:
L- informazzjoni li ġejja għandha tiġi pprovduta wkoll fil- pamflet adattat:
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 • Li jekk l- imsieħba tiegħu toħroġ tqila, għandu jinforma lit- tabib li qed jikkurah immedjatament
Patient Card
Kard tal- pazjent
The patient card shall contain the following elements: • Verification that appropriate counselling has taken place • Documentation of childbearing status potential • Pregnancy test dates and results
Il- kard tal- pazjent għandu jkun fiha l- elementi li ġejjin: • Verifika li ngħata parir adattat • Dokumentazzjoni ta ’ l- istat tal- potenzjal li jista ’ jkollhom it- tfal • Dati li fihom sar it- test tat- tqala u riżultati
What is Revlimid?
X' inhu Revlimid?
Revlimid is a medicine containing the active substance lenalidomide.
Revlimid hu mediċina li fiha s- sustanza attiva lenalidomide.
It is available as capsules (white:
Huwa disponibbli f' forma ta 'kapsuli (bojod:
5 mg; blue-green and yellow:
5 mg; blu- ħodor u sofor:
10 mg; blue and white:
10 mg; blu u bojod:
15 mg; white:
15 mg; bojod:
What is Revlimid used for?
Għal xiex jintuża Revlimid?
Revlimid is an anticancer medicine.
Revlimid hu mediċina għal kontra l- kanċer.
It is used in combination with dexamethasone (an anti-inflammatory medicine) to treat adult patients with multiple myeloma whose disease has been treated at least once in the past.
Jintuża flimkien ma 'dexamethasone (mediċina antinfjammattorja) fit- trattament ta' pazjenti adulti b' mjeloma multipla sottoposti ta 'l- inqas għal trattament wieħed fl- imgħoddi.
Multiple myeloma is a cancer of the plasma cells in the bone marrow.
Il- mjeloma multipla hi kanċer fiċ- ċelluli tal- plażma fil- mudullun ta 'l - għadam.
Because the number of patients with multiple myeloma is low, the disease is considered ‘ rare’, and Revlimid was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 12 December 2003.
Billi n- numru ta 'pazjenti bil- mjeloma multipla hu wieħed baxx, il- marda hi kkunsidrata' rari 'u Revlimid kien ikkwalifikat bħala' mediċina orfni '(mediċina użata f' mard rari) fit- 12 ta' Diċembru 2003.
How is Revlimid used?
Kif jintuża Revlimid?
Treatment with Revlimid must be initiated and monitored by doctors who have experience in the management of multiple myeloma.
It- trattament b' Revlimid għandu jinbeda u jiġi sorveljat minn tobba b' esperjenza fit- trattament tal - mjeloma multipla.
Revlimid is taken in repeated 28-day cycles: the patient takes the medicine once a day for 21 days, followed by seven days off the medicine.
Revlimid jittieħed f' ċikli ripetuti ta '28 jum: il- pazjent jieħu l- mediċina darba kuljum għal 21 jum, u wara ma jeħodhiex aktar għal sebat ijiem.
Dexamethasone should be taken at a dose of 40 mg once a day on days 1 to 4, 9 to 12 and 17 to 20 of the first four cycles, and on days 1 to 4 thereafter.
Dexamethasone għandu jittieħed f' doża ta '40 mg darba kuljum u fil- ġranet minn 1 sa 4, 9 sa 12 u 17 sa 20 ta' l- ewwel erba 'ċikli, u wara fil- ġranet minn 1 sa 4.
The recommended dose of Revlimid is 25 mg a day.
Id- doża rakkomandata ta 'Revlimid hi ta' 25 mg kuljum.
This dose should be reduced or treatment interrupted depending on the patient’ s condition and the levels of platelets (components in the blood that aid clotting) and of neutrophils (a type of white blood cell).
Din id- doża għandha titnaqqas jew it - trattament jitwaqqaf skond il- kundizzjoni tal- pazjent u l- livelli ta 'platelets (komponenti fid- demm li jgħinuh jagħqad) u ta' newtrofili (tip ta 'ċelluli bojod tad- demm).
A lower dose should also be used in patients who have moderate or more severe problems with their kidneys.
F' pazjenti bi problemi fil- kliewi minn moderati jew aktar gravi wkoll għandha tintuża doża inqas qawwija.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal aktar tagħrif, ara s - Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
Revlimid should be taken at around the same time each day.
Revlimid għandu jittieħed bejn wieħed u ieħor fl- istess ħin kuljum.
The capsules should be swallowed whole, preferably with water.
Il- kapsuli għandhom jinbelgħu sħaħ, preferibbilment ma 'l- ilma.
How does Revlimid work?
Kif jaħdem Revlimid?
The active substance in Revlimid, lenalidomide, is an immunomodulating agent.
Is- sustanza attiva f' Revlimid, lenalidomide, hija aġent immunomodulanti.
This means that it affects the activity of the immune system (the body ’ s natural defences).
Dan ifisser li taffettwa l - attività tas- sistema immunitarja (id- difiżi naturali tal- ġisem).
Lenalidomide works in a number of different ways in multiple myeloma: it blocks the development of tumour cells, prevents
Lenalidomide jaħdem b' numru ta 'modi differenti fil- mjeloma multipla: jimblokka l- iżvilupp ta' ċelluli tumurali, jipprevjeni li l- arterji u l- vini
Reproduction is authorised provided the source is acknowledged. the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the cancerous cells.
Reproduction is authorised provided the source is acknowledged. jikbru f' tumuri u jistimula wkoll lil xi ċelloli speċjalizzati tas- sistema immunitarja biex jattakkaw iċ - ċelluli tal- kanċer.
How has Revlimid been studied?
Kif ġie studjat Revlimid?
The effects of Revlimid were first tested in experimental models before being studied in humans.
L- effetti ta 'Revlimid għall- ewwel ġew ittestjati f' mudelli sperimentali qabel ma' ġew studjati fil - bniedem.
Revlimid was studied in two main studies involving 704 patients with multiple myeloma.
Revlimid ġie studjat f' żewġ studji ewlenin li fihom ħadu sehem 704 pazjenti b' mjeloma multipla.
In both studies, Revlimid was compared with placebo (a dummy treatment), both taken in combination with dexamethasone.
Fiż - żewġ studji, Revlimid tqabbel mal- plaċebo (trattament finta), u kemm Revlimid kif ukoll il- plaċebo ttieħdu flimkien ma 'dexamethasone.
The main measure of effectiveness was how long it took until the disease got worse.
Il- kejl ewlieni ta 'l- effikaċja kien kemm għadda żmien sa ma l - marda qalbet għall- agħar.
What benefit has Revlimid shown during the studies?
X' inhuma l- benefiċċji ta 'Revlimid li ntwerew f' dawn l- istudji?
Revlimid was more effective than placebo at preventing a worsening of multiple myeloma.
Revlimid irriżulta iktar effikaċi mill- plaċebo biex jipprevjeni l- mjeloma multipla milli taqleb għall - agħar.
The results of the two studies taken together showed that, on average, it took 48.3 weeks for the disease to get worse in patients taking Revlimid, compared with 20.1 weeks in those taking placebo.
Ir- riżultati ta 'dawn iż- żewġ studji meħudin flimkien urew li, bħala medja, l- marda damet 48. 3 ġimgħat biex qalbet għall- agħar fil- pazjenti li kienu qed jieħdu Revlimid, meta mqabbel ma' 20. 1 ġimgħa f' dawk li kienu qed jieħdu l- plaċebo.
What is the risk associated with Revlimid?
X' inhuma r- riskji assoċjati ma 'Revlimid?
The most common side effects with Revlimid (seen in more than 1 patient in 10) are neutropenia (low neutrophil counts), fatigue (tiredness), asthenia (weakness), constipation, muscle cramp, thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), diarrhoea and rash.
L- iktar effetti sekondarji komuni b' Revlimid (li dehru f' aktar minn pazjent 1 minn 10) huma newtropenija (tnaqqis fl- għadd ta 'newtrofili), għeja, astenija (dgħufija), stitikezza, bugħawwieġ, tromboċitopenija (tnaqqis fl- għadd ta' platelets), anemija (tnaqqis fiċ- ċelluli ħomor tad- demm), dijarrea u raxx.
For the full list of all side effects reported with Revlimid, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati b' Revlimid, ara l- Fuljett ta' Tagħrif.
Lenalidomide is expected to be harmful to the unborn child.
Huwa maħsub li lenalidomide jagħmel ħsara lill- fetu.
Therefore, Revlimid must not be used in women who are pregnant.
Għaldaqstant, Revlimid ma għandux jintuża f' nisa tqal.
It must also not be used in women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment.
Lanqas ma għandu jintuża minn nisa li jistgħu joħorġu tqal, sakemm dawn ma jiħdux il - passi kollha meħtieġa biex ikun żgurat li mhumiex tqal qabel ma jibda t- trattament u li ma jinqabdux tqal waqt u ftit wara t- trattament.
Revlimid should not be used by people who may be hypersensitive (allergic) to lenalidomide or any of the other ingredients.
Revlimid ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal lenalidomide jew għal xi sustanza oħra tagħha.
Why has Revlimid been approved?
Għaliex ġie approvat Revlimid?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in combination with dexamethasone, Revlimid’ s benefits are greater than its risks for the treatment of multiple myeloma patients who have received at least one prior therapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li, meta jintuża flimkien ma 'dexamethasone, il- benefiċċji ta' Revlimid huma ogħla mir- riskji tiegħu fit- trattament ta 'pazjenti li jbatu minn mjeloma multipla li kienu sottoposti qabel għal terapija ta' l- inqas darba.
The Committee recommended that Revlimid be given marketing authorisation.
Il - Kumitat irrakkomanda li Revlimid jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Revlimid?
X' miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta 'Revlimid?
The company that makes Revlimid will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining the fact that it is expected to be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely.
Il- kumpanija li tipproduċi Revlimid se tipprovdi ittra u kitts edukattivi għall- opertaturi fil- kura tas - saħħa kif ukoll opuskoli għall- pazjenti, li fihom tispjega li probabbilment jagħmel ħsara lill- fetu u tiddeskrivi b' mod dettaljat dak li jeħtieġ isir għal użu sigur tal- mediċina.
It will also supply cards for patients to ensure that all appropriate safety measures have been taken by each patient.
Hija se tpoġġi għad - dispożizzjoni skedi apposta għal pazjenti biex ikun żgurat li kull pazjent jadotta l- miżuri ta 'sigurtà kollha meħtieġa.
Each Member State will also ensure that educational materials and patient cards are provided to prescribers and patients.
Kull Stat Membru għandu jiżgura wkoll li l- materjal edukattiv u l- iskedi għall - pazjenti huma pprovduti lit- tobba u lill- pazjenti.
The company will also set up a pregnancy prevention programme in each Member State and collect information on whether the medicine is used outside its approved indication.
Il- kumpanija se tibda wkoll programm ta 'prevenzjoni tat- tqala f' kull Stat Membru u se tiġbor tagħrif dwar l- użu potenzjali tal- mediċina barra mill- indikazzjoni approvata.
The boxes containing Revlimid capsules also include a warning stating that lenalidomide is expected to be harmful to the unborn child.
Il- kaxxi li fihom Revlimid kapsuli għandhom jinkludu wkoll twissija li tgħarraf li lenalidomide jista 'jagħmel il- ħsara lill- fetu.
Other information about Revlimid:
Aktar tagħrif dwar Revlimid:
The European Commission granted a marketing authorisation valid throughout the European Union for Revlimid to Celgene Europe Limited on 14 June 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Revlimid lil Celgene Europe Limited fl- 14 ta 'Ġunju 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Revlimid is available here.
Is- sommarju ta 'l- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni għal Revlimid huwa disponibbli hawn.
The full EPAR for Revlimid can be found here.
L- EPAR sħiħ dwar Revlimid jista 'jiġi kkonsultat hawn.
Pharmaceutical EU Number
Numru ta ’ l- EU
Route of administration
Kapsula iebsa
Package size
21 kapsula
EU/ 1/ 07/ 391/ 001 EU/ 1/ 07/ 391/ 002 EU/ 1/ 07/ 391/ 003 EU/ 1/ 07/ 391/ 004
EU/ 1/ 07/ 391/ 002 EU/ 1/ 07/ 391/ 003
Revlimid Revlimid Revlimid Revlimid
Revlimid Revlimid
5 mg 10 mg 15 mg 25 mg
10 mg 15 mg
Hard capsule Hard capsule Hard capsule Hard capsule
Kapsula iebsa Kapsula iebsa
Oral use Oral use Oral use Oral use
Użu orali Użu orali
Blister (PCTFE/ PVC/ alu) Blister (PCTFE/ PVC/ alu) Blister (PCTFE/ PVC/ alu) Blister (PCTFE/ PVC/ alu)
Folja (PCTFE/ PVC/ aluminju) Folja (PCTFE/ PVC/ aluminju)
21 capsules 21 capsules 21 capsules 21 capsules
21 kapsula 21 kapsula
Revlimid 5 mg hard capsules
Revlimid 5 mg kapsuli iebsin
Each capsule contains 5 mg of lenalidomide.
Kull kapsula fiha 5 mg ta ’ lenalidomide.
Each capsule contains 147 mg of anhydrous lactose.
Kull kapsula fiha 147 mg ta ’ anhydrous lactose.
White capsules marked “ REV 5 mg”.
Kapsuli bojod immarkati “ REV 5 mg ”.
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
Revlimid flimkien ma ’ dexamethasone hu indikat għall- kura ta ’ pazjenti b’ mjeloma multipla li rċievew mill- inqas terapija waħda fil- passat.
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma (MM).
Il- kura trid tinbeda u tkun immonitorjata taħt is- superviżjoni ta ’ tobba b’ esperjenza fl- immaniġġjar ta ’ mjeloma multipla (MM).
Administration Revlimid capsules should be taken at about the same time each day.
Kif Jingħata Il- kapsuli Revlimid għandhom jittieħdu bejn wieħed u ieħor fl- istess ħin kuljum.
The capsules should not be broken or chewed.
Wieħed m’ għandux jaqsam il- kapsuli jew jomgħodhom.
The capsules should be swallowed whole, preferably with water, either with or without food.
Il- kapsuli għandhom jinbelgħu sħaħ, preferibbilment ma ’ l- ilma, ma ’ l- ikel jew mingħajru.
If less than 12 hours has elapsed since missing a dose, the patient can take the dose.
Jekk inqas minn 12- il siegħa jkunu għaddew minn meta l- pazjent ikun nesa jieħu d- doża, il- pazjent jista ’ jieħu d- doża.
If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
Jekk iktar minn 12- il siegħa jkunu għaddew minn meta l - pazjent ikun nesa jieħu d- doża fil- ħin normali, il- pazjent m’ għandux jieħu d- doża, iżda għandu jieħu d- doża li jmiss fil- ħin normali l- jum ta ’ wara.
Recommended dose The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles.
Doża rakkomandata Id- doża tal- bidu rakkomandata ta ’ lenalidomide hi 25 mg mill- ħalq darba kuljum f’ jiem 1- 21 ta ’ ċikli ripetuti ta ’ 28 jum.
The recommended dose of dexamethasone is 40 mg orally once daily on days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily on days 1-4 every 28 days.
Id- doża rakkomandata ta ’ dexamethasone hi ta ’ 40 mg mill- ħalq darba kuljum f’ jiem 1- 4, 9- 12, u 17- 20 ta ’ kull ċiklu ta ’ 28 jum għall- ewwel 4 ċikli tat- terapija, u mbagħad 40 mg darba kuljum f’ jiem 1- 4 kull 28 jum.
Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4).
Id- dożaġġ jitkompla jew jinbidel skond is- sejbiet kliniċi u tal - laboratorju (ara sezzjoni 4. 4).
Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) < 1.0 x 109/ l, and/ or platelet counts < 75 x 109/ l or, dependent on bone marrow infiltration by plasma cells, platelet counts < 30 x 109/ l.
Il- kura b’ lenalidomide m’ għandhiex tinbeda jekk l- Għadd Assolut tan- Newtrofili (Absolute Neutrophil Counts - ANC) ikun ta ’ < 1. 0 x 109/ l u/ jew l- għadd tal- plejtlits ikun ta ’ < 75 x 109/ l jew, dipendenti fuq l- infiltrazzjoni ta ’ l- għadma tal- mudullun miċ- ċelluli tal- plażma, l- għadd tal- plejtlits ikun ta ’ < 30 x 109/ l.
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.
2 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.
2 • Dose reduction steps
• Passi biex tnaqqas id- doża
Starting dose Dose level 1 Dose level 2 Dose level 3
Doża tal- bidu Livell tad- doża 1 Livell tad- doża 2 Livell tad- doża 3
•
• Għadd tal- plejtlits
Platelet counts
Tromboċitopenja
Thrombocytopenia
Kors Rakkomandat Waqqaf il- kura b’ lenalidomide Kompli lenalidomide fil- Livell tad - Doża 1
When platelets First fall to < 30 x 109/l Return to ≥ 30 x 109/l For each subsequent drop below 30 x 109/l Return to ≥ 30 x 109/l
Għal kull waqgħa sussegwenti taħt 30 x 109/ l Imorru lura għal ≥ 30 x 109/ l
Recommended Course Interrupt lenalidomide treatment Resume lenalidomide at Dose Level 1 Interrupt lenalidomide treatment Resume lenalidomide at next lower dose level (Dose Level 2 or 3) once daily.
Waqqaf il- kura b’ lenalidomide Kompli lenalidomide fil- livell tad- doża iktar baxx li jkun imiss (Livell tad - Doża 2 jew 3) darba kuljum.
Do not dose below 5 mg once daily.
Tieħux doża ta ’ inqas minn 5 mg darba kuljum.
• Absolute Neutrophil counts (ANC)
• Għadd Assolut tan- Newtrofili (ANC)
When neutrophils First fall to < 0.5 x 109/l Return to ≥ 0.5 x 109/l when neutropenia is the only observed toxicity Return to ≥ 0.5 x 109/l when dose-dependent haematological toxicities other than neutropenia are observed
Meta n- newtrofili L- ewwel jaqgħu għal < 0. 5 x 109/ l Imorru lura għal ≥ 0. 5 x 109/ l meta n - newtropenja hi l- unika tossiċità li tkun osservata
Recommended Course Interrupt lenalidomide treatment Resume lenalidomide at Starting Dose once daily Resume lenalidomide at Dose Level 1 once daily
Kors Rakkomandat Waqqaf il- kura b’ lenalidomide Kompli lenalidomide fid- Doża tal- Bidu darba kuljum
For each subsequent drop below < 0.5 x 109/l Return to ≥ 0.5 x 109/l
Imorru lura għal ≥ 0. 5 x 109/ l meta tossiċitajiet ematoloġiċi li jiddependu mid - doża li mhumiex oħrajn ikunu osservati
Interrupt lenalidomide treatment Resume lenalidomide at next lower dose level (Dose Level 1, 2 or 3) once daily.
Waqqaf il- kura b’ lenalidomide Kompli lenalidomide fil- livell tad- doża iktar baxx li jkun imiss (Livell tad - Doża 1, 2 jew 3) darba kuljum.
In case of neutropenia, the physician should consider the use of growth factors in patient management.
F’ każ ta ’ newtropenja, it- tabib għandu jikkunsidra l- użu ta ’ fatturi tat- tkabbir fl- immaniġġjar tal - pazjent.
Paediatric patients There is no experience in children and adolescents.
Pazjenti pedjatriċi M’ hemmx esperjenza dwar l- użu fit- tfal u adolexxenti.
Therefore, lenalidomide should not be used in the paediatric age group (0-17 years).
Għalhekk, lenalidomide m’ għandux jintuża fil - grupp ta ’ l- età pedjatrika (0- 17- il sena).
Elderly patients The effects of age on the pharmacokinetics of lenalidomide have not been studied.
Pazjenti anzjani L- effetti ta ’ l- età fuq il- farmakokinetiċi ta ’ lenalidomide ma kienux studjati.
Lenalidomide has been used in clinical trials in multiple myeloma patients up to 86 years of age (see section 5.1).
Lenalidomide intuża fi studji kliniċi f’ pazjenti b’ mjeloma multipla li kellhom sa 86 sena (ara sezzjoni 5. 1).
The percentage of patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
Il- perċentwali ta ’ pazjenti li kellhom 65 sena jew iktar ma kienx differenti b’ mod sinifikattiv bejn il- gruppi ta ’ lenalidomide/ dexamethasone u tal- plaċebo/ dexamethasone.
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.
3 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.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it would be prudent to monitor renal function.
Minħabba li pazjenti anzjani għandhom iktar ċans li jkollhom tnaqqis fil- funzjoni renali, għandha tingħata attenzjoni fl- għażla tad - doża, u jkun prudenti li jsir monitoraġġ tal- funzjoni renali.
Use in patients with impaired renal function Lenalidomide is substantially excreted by the kidney, therefore care should be taken in dose selection and monitoring of renal function is advised.
L- użu f’ pazjenti b’ indeboliment fil- funzjoni renali Lenalidomide jitneħħa b’ mod sostanzjali mill- kliewi, u għalhekk, għandha tingħata attenzjoni fl - għażla tad- doża u l- monitoraġġ tal- funzjoni renali hu rakkomandat.
3 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.