qanastek/EMEA-V3 huggingface dataset:
171 Diltiazem or similar medicines (called calcium channel blockers): when you start taking SUSTIVA, your doctor may need to adjust your dose of the calcium channel blocker.
Diltiazem jew mediċini simili (magħrufin bħala imblokkaturi tal- kanal tal- kalċju): meta tibda tieħu SUSTIVA, it- tabib tiegħek jista ’ jkollu bżonn jaġġusta d- doża tiegħek tal - imblokkatur tal- kanal tal- kalċju.
Driving and using machines SUSTIVA may cause dizziness, impaired concentration, and drowsiness.
Sewqan u tħaddim ta ’ magni Waqt il- kura bi SUSTIVA ġew irrapurtati sturdament, tnaqqis fil- konċentrazzjoni u ngħas.
HOW TO TAKE SUSTIVA
KIF JITTIEĦED SUSTIVA
The dose for children weighing less than 40 kg is calculated by body weight and is taken once daily as shown below:
• Is- soluzzjoni orali ta ’ SUSTIVA jistgħu jittieħu ma ’ l- ikel jew mingħajr ikel. • Id- doża għall- adulti, u t- tfal li jiżnu 40 kg u iżjed, hija ta ’ 24 ml kuljum. • Id- doża għal tfal li jiżnu inqas minn 40 kg tiġi kkalkulata skond il- piż tal- ġisem u tittieħed darba kuljum skond it- tabella ta ’ hawn taħt:
SUSTIVA oral solution (30 mg/ml) Dose (ml)
SUSTIVA soluzzjoni orali (30 mg/ ml) Doża (ml)
13 to < 15 15 to < 20 20 to < 25
13 sa < 15
12 13 15
12 182
172 The dose of SUSTIVA oral solution in mg is not the same as for SUSTIVA hard capsules or film- coated tablets.
Id- doża ta ’ SUSTIVA soluzzjoni orali f’ mg mhix l- istess bħal SUSTIVA kapsuli ibsin jew pilloli miksijin b’ rita.
The dose of SUSTIVA oral solution must be measured using the oral syringe supplied in the carton.
Id- doża ta ’ SUSTIVA soluzzjoni orali trid tiġi ppreparata b’ siringa orali li tigi fil- kartuna.
20
Meta jintuża l- ewwel darba, l- adapter tal- flixkien irid jitpoġġa fl -
The 16 14 12 10 8 6 4 2
Biex tagħmel hekk, neħħi l- għatu li ma jinfetaħx 14 12 10 8 6 4 2
bottle adapter, which is already fixed to the nozzle of the syringe, can 0
L- adapter tal- flixkun, li diġa` huma mwaħħal 0
then be fitted into the neck of the bottle and pressed firmly down.
mal- bokka tas- siringa, jista ’ jiddaħħal fl- għonq tal- flixkun u magħfus sew ‘ l isfel.
Separate the syringe from the adapter.
• Issepara s- siringa mill- adapter.
The adapter should now fit closely to the neck so that the cap can be replaced without removing it.
L- adapter għandu jkun marbut sewe ma ’ l- għonq biex l- għatu jista ’ jitneħħa mingħajr ma dan jinqala ’.
With the bottle upright, fit the tip of the syringe into the bottle adapter.
• Bil- flixkun wieqaf, poġġu tarf is- siringa fl- adapter tal- flixkun.
Turn the bottle upside down with the syringe still in place.
• Dawwar il- flixkun rasu ‘ l isfel bis- siringa għadha f’ postha.
To measure the dose accurately, keep the bottle upside down and push the plunger in slowly until the top of the black ring (the edge nearest the syringe tip) lines up with the dose.
183 • Biex tkejjel id- doża bir- reqqa, żomm il- flixkun rasu ‘ l isfel u mbotta l - planġer ‘ il ġewwa bil- mod sakemm il- parti ta ’ fuq taċ- ċirku l- iswed (it- tarf l- eqreb lejn il- ponta tas- siringa) tasal sad- doża.
Turn the bottle the right way up
Dawwar il -
and remove the syringe.
flixkun sew u neħħi s- siringa.
Wipe the adapter and replace the cap tightly
Imsaħ l- adapter u agħlaq sew bit- tapp.
173 Before giving the dose of the oral solution make sure that the patient is sitting or standing upright.
• Qabel ma tagħti d- doża tas- soluzzjoni orali kun ċert/ a li l- pazjenti qiegħed bil- qiegħda dritt jew bil- wieqfa.
Rapid squirting into the mouth
Tagħfis bil- għaġla
ml 18 20 may cause choking.
ml 18 20 jista ’ jwassal biex dak li jkun jifga ’.
If you stop taking SUSTIVA When your SUSTIVA supply starts to run low, get more from your doctor or pharmacist.
Jekk tieqaf tieħu SUSTIVA Meta l- ħażna tieghek ta ’ SUSTIVA tibda tonqos, ġib iktar mit- tabib jew spiżjar tiegħek.
When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by SUSTIVA or by other medicines that you are taking at the same time, or by the HIV disease itself.
L- iktar reazzjonijiet mhux mixtieqa notabbli marbuta ma ’ SUSTIVA meta jingħata flimkien ma ’ mediċini oħra ta ’ kontra l- HIV u li ġew irrapurati jinkludu raxx u sintomi marbuta mas- sistema nervuża.
You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA.
184 Għandek tikkonsulta lit- tabib jekk għandek raxx, billi xi wħud jistgħu ikunu serji; madankollu, il- biċċa l- kbira mill- każijiet ta ’ raxx jgħibu mingħajr bidla fil- kura bi SUSTIVA.
If you are affected your doctor may suggest that you take SUSTIVA at bedtime.
Jekk tkun affettwat it- tabib tiegħek jista ’ jissuġġerilek li tieħu SUSTIVA f’ ħin l- irqad u fuq stonku vojt.
Diarrhoea occurred in children who took SUSTIVA oral solution and nelfinavir in combination with other antiretroviral medicines.
It- tfal li ħadu SUSTIVA soluzzjoni orali u nelfinavir flimkien ma ’ mediċini oħra antiretrovirali kellhom dijarrea.
174 The frequency of the side effects listed below is defined using the following conventions:
Il- frekwenza tal- effetti sekondarji elenkati taħt hija definita permezz tal- konvenzjonijiet li ġejjin:
- nervousness, forgetfulness, problems with coordin ation, confusion, fitting (seizures), abnormal
Effetti sekondarji komuni • ħolm mhux normali, diffikultà fil- konċentrazzjoni, sturdament, uġigħ ta ’ ras, diffikultà fl- irqad, ħedla • uġigħ ta ’ stonku, dijarea, tħossok ma tiflaħx (nawsja), rimettar • ħakk • għeja • tħossok inkwetat/ a, tħossok imdejjaq/ imdejjqa
You may lose fat from your legs, arms and face, gain fat around the abdomen (tummy) and other internal organs, get larger breasts or fatty lumps on the back of the neck ('buffalo hump').
Tista ’ titlef xaħam mis- saqajn, dirgħajn u l- wiċċ tiegħek u żżid xaħam fiż - żaqq u f’ organi interni oħra, tkabbar is- sider jew boċċi mxaħħmin fuq wara ta ’ l- għonq (ħotba ta ’ buflu).
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, increased fat levels in the blood (hyperlipaemia) and resistance to insulin.
185 It- terapija antiretrovirali kombinata tista ’ tikkawża wkoll livelli ogħla ta ’ lactic acid u zokkor fil- demm, żieda fl- ammont ta ’ xaħam fid- demm (iperlipemija) u reżistenza għall- insulina.
The bottle of SUSTIVA oral solution should be used within one month after first opening.
Il- flixkun ta ’ SUSTIVA soluzzjoni orali għandu jintuża fi żmien xahar minn meta jinfetaħ l- ewwel darba.
FURTHER INFORMATION
X’ fih SUSTIVA:
The other ingredients are: medium chain triglycerides, benzoic acid (E210) and strawberry/mint flavour.
• Kull ml ta ’ SUSTIVA soluzzjoni orali fig 30 mg tas- sustanza attiva efavirenz. • L- ingredjenti l- oħra huma medium chain triglycerides, benzoic acid (E210) u togħma ta ’ frawli/ menta.
What SUSTIVA looks like and contents of the pack SUSTIVA 30 mg/ml oral solution is supplied in bottles of 180 ml.
SUSTIVA 30 mg/ ml soluzzjoni orali tiġi fi fliexken ta ’ 180 ml.
България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info-msdbg@merck.com
186 България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info- msdbg@ merck. com
Τηλ: +357 22866700 info_cyprus@merck.com
187 Τηλ: +357 22866700 info_ cyprus@ merck. com
177 PACKAGE LEAFLET:
188 FULJETT TA ’ TAGĦRIF:
SUSTIVA 600 mg film-coated tablets efavirenz
SUSTIVA 600 mg pilloli miksija efavirenz
178 SUSTIVA must be taken with other medicines that act against the HIV virus.
189 • SUSTIVA irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
179 stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
190 ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa u indiċi ogħla tal - massa tal- ġisem fost oħrajn.
Use in children SUSTIVA film-coated tablets are not suitable for children weighing less than 40 kg.
Użu fit- tfal Pilloli SUSTIVA miksijin b’ rita ta ’ 600 mg jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar li jistgħu jibilgħu il- pilloli (ara Kif tieħu SUSTIVA.)
Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
191 Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.
180 Diltiazem or similar medicines (called calcium channel blockers): when you start taking SUSTIVA, your doctor may need to adjust your dose of the calcium channel blocker.
Diltiazem jew mediċini simili (magħrufin bħala imblokkaturi tal- kanal tal- kalċju): meta tibda tieħu SUSTIVA, it- tabib tiegħek jista ’ jkollu bżonn jaġġusta d- doża tiegħek tal - imblokkatur tal- kanal tal- kalċju.
Taking SUSTIVA with food and drink Taking SUSTIVA on an empty stomach, may reduce the undesirable effects.
Meta tieħu SUSTIVA ma ’ l- ikel u max- xorb Jekk tieħu SUSTIVA fuq stonku vojt tista ’ ttaffi l- effetti mhux mixtieqa.
Pregnancy and breast-feeding Women should not get pregnant during treatment with SUSTIVA and for 12 weeks thereafter.
Tqala u Treddigħ In- nisa m’ għandhomx jinqabdu tqal waqt kura bi SUSTIVA u għal 12- il ġimgħa wara.
Important information about some of the ingredients of SUSTIVA This medicinal product contains 250 mg of lactose in each 600-mg daily dose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ SUSTIVA Dan il- prodott mediċinali fih 250 mg ta ’ lactose f’ kull doża ta ’ kuljum ta ’ 600 mg.
SUSTIVA is for oral use.
192 • SUSTIVA huwa għal użu orali.
SUSTIVA must be taken every day.
Stonku vojt huwa definit bħala siegħa qabel jew sagħtejn wara ikla. • Id- doża għall- adulti, u t- tfal li jiżnu 40 kg u iżjed, hija ta ’ 600 mg kuljum. • Id- doża ta ’ SUSTIVA jista ’ jkollha bżonn tiżdied jew titnaqqas jekk tkun qed tieħu ċerti mediċini (ara Meta tieħu mediċini oħra). • SUSTIVA irid jittieħed kuljum. • SUSTIVA qatt m’ għandu jintuża waħdu biex jikkura l- HIV.
If you take more SUSTIVA than you should If you take too much SUSTIVA, contact your doctor or nearest emergency department for advice.
Jekk tieħu SUSTIVA aktar milli suppost Jekk tieħu wisq SUSTIVA ikkuntattja lit- tabib jew l- eqreb dipartiment tal- emerġenza għal parir.
You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA.
Għandek tikkonsulta lit- tabib jekk għandek raxx, billi xi wħud jistgħu ikunu serji; madankollu, il- biċċa l- kbira mill- każijiet ta ’ raxx jgħibu mingħajr bidla fil- kura bi SUSTIVA.
Very common side effects
193 Effetti sekondarji komuni ħafna • raxx tal- ġilda
Do not use SUSTIVA after the expiry date which is stated on the bottle or blister and on the carton after EXP.
Tużax SUSTIVA wara d- data ta ’ l- iskadenza li tinstab fuq il- flixkun jew folja u l- kartuna wara JIS.
The tablets are printed with inks containing hypromellose (E464), propylene glycol, cochineal carminic acid (E120), indigo carmine (E132) and titanium dioxide (E171).
• Kull pillola SUSTIVA miksija b’ rita fiha 600 mg tas- sostanza attiva efavirenz. • L- ingredjenti l- oħra fil- qalba tal- pillola huma: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, u magnesium stearate. • Ir- rita tal- kisi fiha: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide isfar (E172), u xama ’ tal- carnauba. • Il- pilloli huma stampati b’ linka li fiha hypromellose (E464), propylene glycol, cochineal carminic acid (E120), indigo carmine (E132) u titanium dioxide (E171).
What SUSTIVA looks like and contents of the pack SUSTIVA 600 mg film-coated tablets are supplied in bottles of 30 tablets.
Il- pilloli SUSTIVA miksija b’ rita tat- 600 mg jiġu fi fliexken ta ’ ta ’ 30 pillola.
183 SUSTIVA 600 mg film-coated tablets are also supplied in packs containing 30 x 1 or 90 (3 x 30 x 1) tablets in aluminium/PVC perforated unit dose blisters.
SUSTIVA 600 mg pilloli miksija b’ rita huma fornuti wkoll f’ pakketti li fihom 30 x 1 jew 90 (3 x 30 x 1) pillola f’ folji ta ’ l- aluminju mtaqqab għal dożi waħedhom.
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad - daqsijiet kollha jkunu għall- skop kummerċjali
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@msd.dk
195 Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@ msd. dk
Lietuva UAB “Merck Sharp & Dohme” Tel.: +370 5 278 02 47 msd_lietuva@merck.com
196 Lietuva UAB “ Merck Sharp & Dohme ” Tel.: +370 5 278 02 47 msd_ lietuva@ merck. com
185 ANNEX IV
197 ANNESS IV
186 GROUNDS FOR ONE ADDITIONAL RENEWAL
198 RAĠUNIJIET GĦAL TIĠDID ADDIZZJONALI WIEĦED
Based on the review of the available information, the CHMP was of the opinion that the quality, the safety and the efficacy of this medicinal product continues to be adequately and sufficiently demonstrated and therefore considered that the benefit/risk balance of Sustiva remains favourable.
Fuq il- bażi tal- istudju tal- informazzjoni disponibbli, is- CHMP kien tal- opinjoni li l- kwalità, is- sigurtà u l- effikaċja ta ’ dan il- prodott mediċinali jibqgħu jintwerew b’ mod adegwat u suffiċjenti u għalhekk qies li l- bilanċ benefiċċju/ riskju ta ’ Sustiva jibqa ’ wieħed favorevoli.
187
199
What is Sutent?
X’ inhu Sutent?
Sutent is a medicine containing the active substance sunitinib.
SUTENT huwa mediċina li fiha s- sustanza attiva sunitinib.
It is available as capsules (orange:
Huwa disponibbli f’ kapsuli (oranġjo:
12.5 mg; caramel and orange:
12. 5 mg; kapsuli kulur il- karamella u oranġjo:
50 mg).
25 mg; u kapsuli kulur il- karamella ta ’ 50 mg.
What is Sutent used for?
Għal x’ hiex jintuża Sutent?
Sutent is used to treat patients with one of the following types of cancer: • gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where there is uncontrolled growth of cells in the supporting tissues of these organs.
Sutent jintuża biex jikkura pazjenti b’ wieħed minn dawn it- tipi ta ’ kanċer li ġejjin: • tumur stromali gastrointestinali (GIST), tip ta ’ kanċer (sarkoma) ta ’ l- istonku u l- musrana, fejn ikun hemm żvilupp bla kontroll ta ’ ċelloli fit- tessuti ta ’ sapport ta ’ dawn l- organi.
Sutent is used in GIST patients with tumours that cannot be removed with surgery, or that have spread to other organs, when treatment with imatinib (another anticancer medicine) has failed or cannot be tolerated by the patient; • renal cell carcinoma (RCC), a type of kidney cancer.
Sutent jintuża f’ pazjenti b’ GIST b’ tumuri li ma jistgħux jitneħħew kirurġikament, jew li nfirxu għal organi oħra, fejn kura b’ imatinib (mediċina oħra kontra l- kanċer) ma rnexxietx jew ma tistax tkun ikkontrollata mill- pazjent. • karċinoma taċ- ċellola renali (RCC), forma ta ’ kanċer tal- kilwa li taffettwa ċ- ċelloli tat- tubuli renali.
Sutent is used when the cancer is at an advanced stage, or has spread to other organs.
Sutent jintuża meta l- kanċer ikun fi stadju avvanzat, jew meta jkun infirex għal organi oħra.
How is Sutent used?
Kif jintuża Sutent?
Treatment with Sutent should only be initiated by doctors who have experience in the treatment of GIST or RCC.
Il- kura b’ Sutent għandha tinbeda biss minn tobba li għandhom esperjenza fil- kura ta ’ GIST jew RCC.
Sutent is given in six-week cycles, with 50 mg a day for four weeks, followed by two weeks off treatment.
Sutent jingħata f’ ċikli ta ’ sitt ġimgħat, b’ 50 mg kuljum għal erba ’ ġimgħat, segwiti minn ġimagħtejn bla kura.
Although the recommended dose is 50 mg, this can be adjusted to a higher or lower dose according to the patient’ s response to the treatment, provided that the dose does not go below 25 mg or above 75 mg.
Għalkemm id- doża irrikkmandata hija ta ’ 50 mg, din tista ’ tiġi aġġustata għal doża aktar għolja jew aktar baxxa skond ir- reazzjoni tal- pazjent għall- kura, bil- kundizzjoni li d- doża ma tinżilx taħt 25 mg jew tkun aktar minn 75 mg.
How does Sutent work?
Kif jaħdem Sutent?
The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Is- sustanza attiva f’ Sutent, sunitinib, hija impeditur ta ’ protein kinase.
This means that it blocks some specific enzymes known as protein kinases.
Dan ifisser li timblokka xi enzimi speċifiċi magħrufin bħala protein kinases.
These enzymes can be found in some receptors at the surface of cancer cells, such as the ‘ KIT’ receptors on the surface of GIST cells and similar receptors on the surface of RCC cells, where they are involved in the growth and spread of cancer cells.
Dawn l- enzimi jistgħu jinstabu f’ xi riċetturi fil- wiċċ ta ’ ċelloli tal- kanċer, bħalma huma riċetturi ‘ KIT ’ fuq il- wiċċ ta ’ ċelloli GIST u riċetturi simili fil- wiċċ ta ’ ċelloli RCC, fejn ikunu involuti fl- iżvilupp u fit- tifrix ta ’ ċelloli tal- kanċer.
By blocking these enzymes, Sutent can reduce the growth and spread of the cancer.
Sutent jista ’ jnaqqas l - iżvilupp u t- tifrix tal- kanċer billi jimblokka dawn l- enzimi.
How has Sutent been studied?
Kif ġie studjat Sutent?
Sutent was compared with placebo (a dummy treatment).
L- effetti ta ’ Sutent kienu l- ewwel ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil- bnedmin.
The study was double blinded (neither the doctor nor the patient knew which treatment the patient was receiving), and it measured the time taken for the disease to get worse.
L- istudju kien double blinded (la t- tabib u lanqas il- pazjent ma kienu jafu liema kura kien qed jirċievi l- pazjent), u kejjel iż- żmien li ħadet il- marda biex tiggrava.
In RCC, Sutent was studied in 750 patients whose cancer had not been treated before.
F’ RCC (karċinoma taċ- ċellola renali), Sutent kien studjat f’ 750 pazjent li l- kanċer tagħhom ma kienx ġie ikkurat qabel.
The study compared the effects of Sutent and interferon alfa (the standard first-line treatment for this type of cancer).
L- istudju qabbel l- effetti ta ’ Sutent u interferon alfa (il- kura standard ta ’ l- ewwel għażla għal dan it- tip ta ’ kanċer).
The main measure of effectiveness was ‘ progression-free survival ’ (the length of time until the cancer got worse or the patient died).
Il- miżura ewlenija ta ’ l- effikaċja kienet ‘ sopravivenza ħielsa mill - progressjoni ’ (it- tul ta ’ żmien sakemm il- kanċer iggrava jew il- pazjent miet).
What benefit has Sutent shown during the studies?
X’ benefiċċju wera Sutent waqt l- istudji?
Sutent was more effective than placebo in GIST: it took 27.3 weeks for the disease to get worse in patients who received Sutent and 6.4 weeks in patients who received placebo.
Sutent kien aktar effettiv minn plaċebo f’ GIST: iż- żmien li ittieħed qabel il- marda avvanzat kien ta ’ 27. 3 ġimgħa f’ pazjenti li rċievew Sutent u 6. 4 ġimgħat f’ pazjenti li rċievew plaċebo.
The interim results (results calculated before the study was finished) were sufficiently good for the study to be stopped early and for the patients who were receiving placebo to be switched to Sutent.
Ir- riżultati fl - intervall (riżultati kkalkulati qabel l- istudju ntemm) kienu tajbin biżżejjed sabiex l- istudju jitwaqqaf kmieni u għall- pazjenti li kienu qed jirċievu plaċebo biex jinqalbu għal fuq Sutent.
In RCC, progression-free survival was longer in the patients taking Sutent.
F’ RCC (karċinoma taċ- ċellola renali), is- sopravivenza ħielsa mill- progressjoni kienet itwal f’ pazjenti li qed jieħdu Sutent.
It took 47.3 weeks for the disease to get worse or the patient to die in the Sutent group, compared with 22.0 weeks in the group taking interferon alfa.
Għaddew 47. 3 ġimgħa biex il- marda ggravat jew biex il- pazjent fil- grupp Sutent imut, meta mqabbla ma ’ 22. 0 ġimgħa fil- grupp li jieħdu interferon alfa.
What is the risk associated with Sutent?
X’ inhu r- riskju assoċjat ma ’ Sutent?
In clinical studies, the most common side effects with Sutent (seen in more than 1 patient in 10) were anaemia (low red blood cell counts), neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), hypothyroidism (underactive thyroid gland), decreased appetite, taste disturbance, headache, hypertension (high blood pressure), epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), dyspepsia (heartburn), abdominal (tummy) pain or distension (bloating), constipation, glossodynia (burning or tingling sensation around the mouth), flatulence (gas), oral (mouth) pain, dry mouth, yellow skin or skin discoloration, palmar-plantar erythrodysaesthesia syndrome (swelling and numbness of the palms and soles of the feet), hair colour changes, rash, dry skin, alopecia (hair loss), pain in the extremities (hands and feet) or limbs, fatigue or asthenia (tiredness or weakness), mucosal inflammation (inflammation of the moist body surfaces), oedema (swelling) decreased ejection fraction (reduced amount of blood pumped out in each heartbeat) and decreased weight.
Fi studji kliniċi, l- aktar effetti sekondarji komuni b’ Sutent (dehru f’ aktar minn pazjent 1 minn kull 10) kienu anemija (għadd baxx taċ- ċelloli ħomor tad- demm), newtropinja (għadd baxx tac- ċelloli bojod fid- demm), tromboċitopinja (għadd baxx tal- pjastrini fid- demm), iprotirojdiżmu (nuqqas ta ’ azzjoni fil- glandola tat- tirojde), nuqqas ta ’ aptit, disturb tat- togħma, uġigħ ta ’ ras, pressjoni tad- demm għolja, epistassi (fġir l- imnieħer), dijarea, nawżja (dardir), stomatite (infjammazzjoni ta ’ l- inforra tal- ħalq), rimettar, dispepsja (ħruq ta ’ stonku), uġigħ addominali (ta ’ żaqq) jew distensjoni (nefħa), stitikezza, glossodinja (sensazzjoni ta ’ ħruq jew textix fi jew madwar il- ħalq), flatulenza (gass), uġiegħ orali (fil - ħalq), ħalq niexef, tindis tal- kulur tal- ġilda jew sfura, sindromu ta ’ eritrodiżestiżja palmari- plantari (nefħa u tirżiħ ta ’ l- uċuh ta ’ l- idejn u tal- qiegħ tas- saqajn), bidla fil- kulur tax- xagħar, raxx, ġilda xotta, alopecia (telf ta ’ xagħar), uġigħ fl- estremitajiet (idejn u saqajn), għeja kbira jew astenija (għeja jew dgħjufija), infjammazzjoni mukożali (infjammazzjoni ta ’ l- uċuh umidi tal- ġisem), edema (nefħa) tnaqqis tal- frazzjoni ppumpjata (tnaqqis fl- ammont ta ’ demm ippumpjat ’ l barra f’ kull taħbita tal- qalb) u tnaqqis tal- piż korporju.
For the full list of all side effects reported with Sutent, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Sutent, ara l - Fuljett ta ’ Tagħrif.
Sutent should not be used in people who may be hypersensitive (allergic) to sunitinib or any of the other ingredients.
Sutent m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal sunitinib jew għal xi sustanza oħra tiegħu.
Caution should be taken when it is given with some medicines, such as rifampicin (used in tuberculosis) or ketoconazole (an antifungal medicine).
Għandha tittieħed il- kawtela meta jingħata ma ’ xi mediċini, bħal rifampicin (użat fit- tuberkolożi) jew ketoconazole (mediċina antifungali).
See the Package Leaflet for the list of the medicines that may interact with Sutent.
Ara l- Fuljett ta ’ Tagħrif għal- lista ta ’ mediċini li jistgħu jinteraġġixxu ma ’ Sutent.
Why has Sutent been approved?
Għaliex ġie approvat Sutent?
The Committee for Medicinal Products for Human Use (CHMP) decided that Sutent’ s benefits are greater than its risks for the treatment of unresectable and/ or metastatic malignant GIST after failure of imatinib mesilate treatment due to resistance or intolerance, and for the treatment of advanced and/ or metastatic RCC.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji huma akbar mir- riskji tiegħu għat- trattament ta ’ GIST malinn irrisettibbli u/ jew metastatiku wara li trattament b’ imatinib mesilate ma irnexxiex minħabba reżistenza jew intolleranza u għat- trattament ta ’ RCC metastatiku jew avvanzat.
The Committee recommended that Sutent be given marketing authorisation.
Il- Kumitat irrakkomanda li Sutent jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Sutent was originally given ‘ Conditional Approval’.
Oriġinarjament, Sutent ingħata ‘ Approvazzjoni b’ Kundizzjoni ’.
This means that there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Dan ifisser li hemm aktar evidenza x’ tinġieb dwar il- mediċina, partikolarment fil- kura ta ’ karċinoma taċ- ċellola renali.
As the company had supplied the additional information necessary, the authorisation was switched from ‘ conditional ’ to ‘ normal’ approval on 11 January 2007.
Minħabba li l - kumpanija forniet it- tagħrif addizzjonali neċessarju, l- awtorizzazzjoni nqalbet minn approvazzjoni ‘ b’ kundizzjoni ’ għal ‘ normali ’ fil- 11 ta ’ Jannar 2007.
Other information about Sutent:
Tagħrif ieħor dwar Sutent:
The European Commission granted a marketing authorisation valid throughout the European Union for Sutent to Pfizer Ltd on 19 July 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Sutent lil Pfizer Ltd fid- 19 ta ’ Lulju 2006.
The full EPAR for Sutent can be found here.
L- EPAR sħiħ għal SUTENT jista ’ jiġi kkonsultat hawn.
This summary was last updated in 07-2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ 07- 2008.
EU Number EU/ 1/ 06/ 347/ 001 EU/ 1/ 06/ 347/ 002 EU/ 1/ 06/ 347/ 003 EU/ 1/ 06/ 347/ 004 EU/ 1/ 06/ 347/ 005 EU/ 1/ 06/ 347/ 006
Numru ta ’ l- EU EU/ 1/ 06/ 347/ 001 EU/ 1/ 06/ 347/ 002 EU/ 1/ 06/ 347/ 003 EU/ 1/ 06/ 347/ 004 EU/ 1/ 06/ 347/ 005 EU/ 1/ 06/ 347/ 006
Invented name Sutent Sutent Sutent Sutent Sutent Sutent
Isem inventat SUTENT SUTENT SUTENT SUTENT SUTENT SUTENT
Strength 12.5 mg 25 mg 50 mg 12.5 mg 25 mg 50 mg
Qawwa 12. 5 mg 25 mg 50 mg 12. 5 mg 25 mg 50 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Għamla Farmaċewtika Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (Aclar/ PVC) blister (Aclar/ PVC) blister (Aclar/ PVC)
Il- pakkett flixkun (HDPE) flixkun (HDPE) flixkun (HDPE) Folja (Aclar/ PVC) Folja (Aclar/ PVC) Folja (Aclar/ PVC)
Package size 30 capsules 30 capsules 30 capsules 28 capsules 28 capsules 28 capsules
Daqs tal- pakkett 30 kapsula 30 kapsula 30 kapsula 28 kapsula 28 kapsula 28 kapsula
SUTENT 12.5 mg hard capsules
SUTENT 12. 5 mg kapsuli iebsin
Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
Kull kapsula fiha sunitinib malate, ekwivalenti għal 12. 5 mg ta ’ sunitinib.
80.0 mg of mannitol For a full list of excipients, see section 6.1.
80. 0 mg ta ’ mannitol Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Hard capsules.
Kapsuli iebsin.
Gelatin capsules with orange cap and orange body, printed with white ink “ Pfizer” on the cap, “ STN 12.5 mg” on the body, and containing yellow to orange granules.
Kapsuli tal- ġelatina b’ kappa oranġjo u bil- parti ewlenija oranġjo, bil- kelma “ Pfizer ” stampata b’ inka bajda fuq il- kappa u “ STN 12. 5 mg ” fuq il- parti ewlenija, u li fihom granijiet safrani għal oranġjo.
Gastrointestinal Stromal Tumour (GIST) SUTENT is indicated for the treatment of unresectable and/ or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.
Tumur ta ’ l- istroma gastrointestinali (GIST) SUTENT huwa indikat għat- trattament ta ’ tumur ta ’ l- istroma gastrointestinali (GIST) li ma jistax jitneħħa u/ jew metastiku malinn wara falliment ta ’ trattament b’ imatinib mesylate minħabba reżistenza jew intolleranza.
Metastatic Renal Cell Carcinoma (MRCC) SUTENT is indicated for the treatment of advanced and/ or metastatic renal cell carcinoma (MRCC).
Karċinoma Metastatika taċ- Ċellola Renali (MRCC) SUTENT huwa ndikat għat- trattament ta ’ karċinoma taċ- ċellola renali (MRCC) metastatika u/ jew avvanzata.
Therapy should be initiated by a physician experienced in the treatment of renal cell carcinoma or GIST.
It- terapija għandha tiġi inizjata minn tabib b’ esperjenza fit- trattament ta ’ karċinoma taċ- ċellola renali jew GIST.
The recommended dose of SUTENT is one 50 mg dose orally, taken daily for 4 consecutive weeks, followed by a 2-week rest period (schedule 4/ 2) to comprise a complete cycle of 6 weeks.
Id- doża rrakkomandata ta ’ SUTENT hija doża waħda ta ’ 50 mg oralment, meħuda kuljum għal 4 ġimgħat konsekuttivi, segwita minn perijodu ta ’ serħan ta ’ 2 ġimghat (skeda 4/ 2) biex tikkostitwixxi ċiklu komplut ta ’ 6 ġimgħat.
Dose adjustments Safety and Tolerability Dose modifications in 12.5-mg steps may be applied based on individual safety and tolerability.
Modifikazzjonijiet fid- doża Sigurta ’ u tolerabbilità Modifikazzjonijiet fid- doża b’ inkrimenti ta ’ 12. 5 mg jistgħu jiġu applikati fuq bażi individwali ta ’ sigurtà u tolerabbilità.
Daily dose should not exceed 75 mg nor be decreased below 25 mg.
Id- dożaġġ ta ’ kuljum m’ għandux jeċċedi 75 mg u lanqas għandu jitnaqqas taħt 25 mg.
CYP3A4 Inhibitors/ Inducers Co-administration of potent CYP3A4 inducers such as rifampin, should be avoided (see sections 4.4 and 4.5).
Inibituri / induċituri ta ’ CYP3A4 Ko- amministrazzjoni ta ’ induċituri CYP3A4 potenti bħal ma huma rifampin, għandha tiġi evitata (ara sezzjonijiet 4. 4 u 4. 5).
If this is not possible, the dose of SUTENT may need to be increased in 12.5 mg increments (up to 87.5 mg per day) based on careful monitoring of tolerability.
Jekk dan mhux possibbli, id- doża ta ’ SUTENT tista ’ tkun meħtieġa li tiżdied b’ inkrimenti ta ’ 12. 5 mg (sa 87. 5 mg kuljum) ibbażata fuq sorveljanza bir- reqqa tat- tolerabbilità.
Co-administration of SUTENT with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5).
Ko- amministrazzjoni ta ’ SUTENT ma ’ impedituri CYP3A4 potenti, bħal ma huma ketoconazole, għandha tiġi evitata (ara sezzjonijiet 4. 4 u 4. 5).
If this is not possible the doses of SUTENT may need to be reduced to a minimum of 37.5 mg daily, based on careful monitoring of the tolerability.
Jekk dan mhuwiex possibbli d- dożi ta ’ SUTENT għandhom mnejn jkollhom bżonn jitnaqqsu għal minimu ta ’ 37. 5 mg kuljum, ibbażati fuq sorveljanza bir- reqqa tat- tolerabbilità.
Selection of an alternate concomitant medication with no, or minimal potential to induce or inhibit CYP3A4 should be considered.
2 Selezzjoni ta ’ medikazzjoni konkomitanti alternattiva bla ebda, jew b’ potenzjal minimu li tinduċi jew timpedixxi CYP3A4 għandha tiġi kkunsidrata.
The safety and efficacy of SUTENT in paediatric patients have not been established.
Is- sigurtà u l- effikaċja ta ’ SUTENT f’ pazjenti pedjatriċi ma ġewx stabbiliti.
2 SUTENT should not be used in paediatric population until further data become available.
SUTENT m’ għandux jintuża fil- popolazzjoni pedjatrika ħlief meta aktar dejta issir disponibbli.
Elderly patients use:
Użu f’ pazjenti anzjani:
Approximately 34% of the subjects in clinical studies of SUTENT were 65 or over.
Madwar 34% tas- suġġetti fl- istudji kliniċi ta ’ SUTENT kellhom 65 sena jew aktar.
No significant differences in safety or effectiveness were observed between younger and older patients.
L- ebda differenzi sinifikattivi fis- sigurtà u l- effettività ma kienu osservati bejn pazjenti aktar żgħar jew aktar kbar.
Hepatic Insufficiency:
Indeboliment Epatiku:
No dose adjustment is recommended when administering SUTENT to patients with mild or moderate (Child-Pugh Class A and B) hepatic impairment.
L- ebda aġġustament fid- doża ma huwa rrakkomandat meta SUTENT jingħata lil pazjenti b’ indeboliment epatiku ħafif jew moderat (Klassi Child- Pugh A u B).
SUTENT has not been studied in subjects with Child-Pugh Class C hepatic impairment (see section 5.2).
SUTENT ma ġiex studjat f’ suġġetti b’ indeboliment epatiku Child- Pugh C (ara sezzjoni 5. 2).
Renal Insufficiency:
Indeboliment Renali:
No clinical studies have been performed in patients with impaired renal function.
L- ebda studji kliniċi ma ġew magħmula f’ pazjenti b’ funzjoni renali mxekkla.
(see section 5.2).
(ara sezzjoni 5. 2).
SUTENT may be taken with or without food.
SUTENT jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
If a dose is missed the patient should not be given an additional dose.
Il- pazjent m’ għandux jingħata doża addizzjonali jekk doża ma tkunx ittieħdet.
The patient should take the usual prescribed dose on the following day.
Il- pazjent għandu jieħu d- doża tas- soltu miktuba mit- tabib fil- jum segwenti.
Hypersensitivity to sunitinib malate or to any of the excipients.
Sensitività eċċessiva għal sunitinib malate jew għal xi sustanza mhux attiva.
Co-administration of potent CYP3A4 inducers such as rifampin, may decrease sunitinib plasma concentrations.
Ko- amministrazzjoni ta ’ induċituri CYP3A4 potenti bħal ma huma rifampin, tista ’ tnaqqas il - konċentrazzjonijiet ta ’ sunitinib fil- plażma.
Combination with inducers should therefore be avoided.
Għaldaqstant, għandha tiġi evitata li tingħata ma ’ induċituri.
If this is not possible, the dosage of SUTENT may need to be increased (see sections 4.2 and 4.5).
Jekk dan mhuwiex possibbli, id- dożaġġ ta ’ SUTENT jista ’ jkollu jiġi miżjud (ara sezzjonijiet 4. 2 u 4. 5).
Co-administration of strong CYP3A4 inhibitor such as ketoconazole may increase sunitinib plasma concentrations.
Ko- amministrazzjoni ta ’ impedituri CYP3A4 qawwija bħal ma huwa ketoconazole tista ’ iżżid l - konċentrazzjonijiet ta ’ sunitinib fil- plażma.
Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended.
Hija rrakkomandata l- għażla ta ’ medikazzjoni konkomitanti alternattiva bla ebda jew b’ potenzjal minimu ta ’ inibizzjoni ta ’ l- enzima.
If this is not possible, the dosage of SUTENT may need to be reduced (see sections 4.2 and 4.5).
Jekk dan mhuwiex possibbli, id- dożaġġ ta ’ SUTENT jista ’ jkollu jiġi mnaqqas (ara sezzjonijiet 4. 2 u 4. 5).
Skin and tissues Skin discolouration, possibly due to the active substance colour (yellow) is a common treatment-related adverse event occurring in approximately 30% of patients.
Ġilda u tessuti Tibdil fil- kulur tal- ġilda, possibbilment minħabba l- kulur (isfar) tas- sustanza attiva huwa reazzjoni avversa komuni relatata mat- trattament li sseħħ f’ bejn wieħed u ieħor 30% tal- pazjenti.
Patients should be advised that depigmentation of the hair or skin may also occur during treatment with SUTENT.
Il- pazjenti għandhom jiġu avżati li telf tal- pigmentazzjoni tax- xagħar jew tal- ġilda jista ’ ukoll iseħħ waqt trattament b’ SUTENT.
Other possible dermatologic effects may include dryness, thickness or cracking of the skin, blisters or occasional rash on the palms of the hands and soles of the feet.
Effetti dermatoloġiċi oħra possibbli jistgħu jinkludu xuttaġni, ħxuna jew qsim tal- ġilda, infafet jew xi kultant raxx fuq il- keffef ta ’ l- idejn u l- qiegħan tas- saqajn.
Mouth pain/ irritation was reported in approximately 14% of patients.
Uġigħ/ irritazzjoni fil- ħalq kien irrapportat f’ bejn wieħed u ieħor 14% tal- pazjenti.
Dysgeusia (taste disturbance) was reported in approximately 28% of patients.
Disgewżja (disturb tat- togħma) kienet irrapportata f’ madwar 28% tal- pazjenti.
The above events were not cumulative, were typically reversible and generally did not result in treatment discontinuation.
Ir- reazzjonijiet ta ’ hawn fuq ma kinux kumulattivi, kienu tipikament riversibbli u ġeneralment ma rriżultawx fi twaqqif tat- trattament.
Haemorrhage Haemorrhagic events, some of which were fatal, reported through post-marketing experience, have included GI, respiratory, tumour, urinary tract and brain haemorrhages.
Emorraġija L- episodji ta ’ emorraġija, li wħud minnhom kienu fatali, li ġew irrappurtati mill- esperjenza ta ’ wara t - tqegħid tal- prodott fis- suq, kienu jinkludi emorraġiji gastro- intestinali, respiratorji, tat- tumur, ta ’ l - apparat urinarju u tal- moħħ.
In clinical trials treatment-related tumour haemorrhage occurred in approximately 2% of patients with GIST.
Fil- provi kliniċi, l- emorraġija tat- tumur relatata mat- trattament seħħet f’ bejn wieħed u ieħor 2% tal- pazjenti b’ GIST.
These events may occur suddenly, and in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage.
Dawn ir- reazzjonijiet jistgħu jseħħu f’ daqqa, u fil- każ ta ’ tumuri pulmonari, jistgħu jippreżentaw bħala emopteżi jew emorraġija pulmonari.
Fatal pulmonary haemorrhage occurred in 2 patients receiving SUTENT on a clinical trial of patients with metastatic non-small cell lung cancer (NSCLC).
Fi prova klinika f’ pazjenti b’ kanċer tal- pulmun mhux biċ- ċelloli żgħar metastatiku (NSCLC), emorraġija pulmonari fatali seħħet f’ 2 pazjenti li kienu qed jingħataw SUTENT.
Both patients had squamous cell histology.
Iż- żewġ pazjenti t- tnejn kellhom istoloġija
SUTENT is not approved for use in patients with NSCLC.
SUTENT mhuwiex approvat għal użu f’ pazjenti b’ NSCLC.
Bleeding events occurred in 18% of patients receiving SUTENT in a phase 3 GIST Study compared to 17% of patients receiving placebo.
Stima ta ’ rutina ta ’ din ir- reazzjoni għandha tinkludi għadd taċ- ċelloli tad- demm u eżami fiżiku komplut.
In patients receiving SUTENT for treatment-naïve MRCC, 28% had bleeding events compared to 7% of patients receiving IFN-α.
Reazzjonijiet emorraġiċi seħħew fi 18% ta ’ pazjenti li ngħataw SUTENT fil- fażi 3 ta ’ Studju GIST imqabbla ma ’ 17% ta ’ pazjenti li qegħdin jingħataw plaċebo.
Seven (1.9%) patients on sunitinib malate versus 0% of patients on IFN-α experienced Grade 3 or greater treatment-related bleeding events.
F’ pazjenti li ngħataw Sutent għal trattament MRCC li qatt ma kienu ħadu kura qabel bħalu, 28% kellhom reazzjonijiet emorraġiċi meta kkomparati ma ’ 7% ta ’ pazjenti li ngħataw IFN - α. Seba ’ Pazjenti (1. 9%) fuq sunitinib malate versus 0% ta ’ pazjenti fuq IFN- α esperjenzaw reazzjonijiet emorragiċi tat- tielet Grad (Grad 3), jew ogħla, relatati mat- trattament.
Of patients receiving sunitinib malate for cytokine-
Minn pazjenti li qiegħdin jirċievu sunitinib malate għal MRCC refrattarja għaċ- ċitokini, 26% esperjenzaw emoraġiji.
Routine assessment of this event should include complete blood counts and physical examination.
Eżaminazzjoni regolari ta ’ dan l- avveniment għandu jinkludi test ta ’ l- għadd taċ- ċelluli tad- demm komplut u viżta fiżika.
Epistaxis was the most common treatment-related haemorrhagic adverse event, having been reported for approximately half of the patients with solid tumours who experienced haemorrhagic events.
L- aktar reazzjoni avversa emorraġika relatata mat- trattament komuni kienet l- epistassi, li ġiet irrapportata f’ bejn wieħed u ieħor nofs il- pazjenti b’ tumuri solidi li esperjenzaw reazzjonijiet emorraġiċi.
Some of these events were severe, but very rarely fatal.
Uħud minn dawn ir- reazzjonijiet kienu serji, imma rarament fatali.
Gastrointestinal events Nausea, diarrhoea, stomatitis, dyspepsia and vomiting were the most commonly reported treatment-related gastrointestinal events.
Reazzjonijiet gastrointestinali Tqalligħ, dijarrea, stomatite, dispepsja u remettar kienu l- aktar reazzjonijiet gastrointestinali relatati mat- trattament komunement irrapportati.
Supportive care for gastrointestinal adverse events requiring treatment may include medication with an anti- emetic or anti-diarrhoeal medication.
Kura ta ’ appoġġ għal reazzjonijiet gastrointestinali avversi li jeħtieġu trattament jistgħu jinkludu medikazzjoni b’ anti- emetiku jew medikazzjoni kontra d- dijarea.
Gastrointestinal tract Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred rarely in patients with intra-abdominal malignancies treated with SUTENT.
Passaġġ gastrointestinali Kumplikazzjonijiet gastrointestinali serji, xi daqqiet fatali, inklużi perforazzjoni gastrointestinali, seħħew rarament f’ pazjenti b’ malinnijiet intra- addominali ttrattati b’ SUTENT.
Treatment-related fatal gastrointestinal bleeding occurred in 0.5% of patients receiving placebo in the GIST Phase 3 study.
Emoraġiji gastrointestinali fatali, relatati mat- trattament, seħħew fi 0. 5% tal- pazjenti li kienu jirċievu plaċebo fit - tielet fażi ta ’ l- istudju GIST.
Hypertension Treatment-related hypertension was reported in approximately 16% of patients with solid tumours.
Pressjoni għolja Pressjoni għolja relatata mat- trattament kienet irrapportata f’ madwar 16% tal- pazjenti b’ tumuri solidi.
SUTENT dosing was reduced or temporarily delayed in approximately 2.7% of this patient population.
L- iddożaġġ ta ’ SUTENT kien imnaqqas jew temporanjament imdewwem f’ madwar 2. 7% ta ’ din il - popolazzjoni ta ’ pazjenti.
None of these patients were discontinued from treatment with SUTENT.
L- ebda wieħed minn dawn il- pazjenti ma tneħħa minn fuq it- trattament.
Severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic) occurred in 4.7% of this patient population.
Pressjoni għolja qawwija (> 200 mmHg sistolika jew 110 mmHg dijastolika) seħħew f’ 4. 7% ta ’ din il - popolazzjoni ta ’ pazjenti.
Treatment-related hypertension was reported in approximately 24% of patients receiving sunitinib malate for treatment-naïve MRCC compared to 1% of patients receiving IFN-α.
Pressjoni għolja relatata mat- trattament kienet irrappurtata f ’ approssimament 24% tal- pazjenti li kienu jirċievu sunitinib malate għall- kura ta- MRCC, li qatt ma kienet trattata qabel, mqabbla ma ’ 1% ta ’ pazjenti li jirċievu IFN- α.
Patients should be screened for hypertension and controlled as appropriate.
Pressjoni għolja ħafna żvilluppat fi 5% tal- pazjenti fuq sunitinib malate li qatt ma kienu ttrattati qabel u 1% tal- pazjenti fuq IFN- α.
Temporary suspension is recommended in patients with severe hypertension that is not controlled with medical management.
Twaqqif temporanju huwa rakkomandat f’ pazjenti bi pressjoni għolja qawwija mhix ikkontrollata b’ ġestjoni medika.
Treatment may be resumed once hypertension is appropriately controlled.
It- trattament jista ’ jerġa jitkompla ġaladarba l- pressjoni għolja tkun ikkontrollata kif jixraq.
Haematological Decreased absolute neutrophil counts of grade 3 and 4 severity were reported in 10% and 1.7% of patients on the phase 3 GIST study, respectively, and in 16% and 1.6% of patients on the phase 3 MRCC study, respectively.
Ematoloġiċi Tnaqqis fl- għadd assolut tan- newtrofili ta ’ severità fi grad 3 u 4 kien irrapportat fi 10% u 1. 7% tal - pazjenti, fit- tielet fażi tal- istudju GIST, rispettivament, u f’ 16% u 1. 6% ta ’ pazjenti fit- tielet fażi ta ’ l - istudju MRCC, rispettivament.
Decreased platelet counts of grade 3 and 4 severity were reported in 3.7% and 0.4% of patientson the phase 3 GIST study, respectively, and in 8.2% and 1.1% of patients on the phase 3 MRCC study, respectively.
Tnaqqis fl- għadd tal- plejtlits ta ’ severità fi grad 3 jew 4 kien irrapportat fi 3. 7% u 0. 4% tal- pazjenti, fit- tielet fażi tal- istudju GIST, rispettivament, u f’ 8. 2% u 1. 1% ta ’ pazjenti fit- tielet fażi ta ’ l- istudju MRCC, rispettivament..
None of these events in the phase 3 studies were fatal, but rare fatal haematological events have been reported through post-marketing experience.
L - ebda wieħed mir- reazzjonijiet fit- tielet fażi ma kienu fatali, imma rarament, reazzjonijiet fatali ematoloġiċi ġew irrappurtati minn esperjenza ta ’ wara t- tqeghid f is- suq.
Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.
Għadd taċ- ċelloli tad- demm kompluti għandhom jiġu magħmula fil- bidu ta ’ kull ċiklu tat- trattament għal pazjenti li qegħdin jingħataw trattament b’ SUTENT.
Cardiovascular Cardiovascular events, some of which were fatal, reported through post-marketing experience, have included left ventricular ejection fraction (LVEF) decrease and cardiac failure.
Kardjovaskulari L- episodji kardjovaskulari rrappurtati mill- esperjenza ta ’ wara t- tqegħid tal- prodott fis- suq, li wħud minnhom kienu fatali, kienu jinkludu tnaqqis fil- frazzjoni ta ’ tfigħ ’ il barra tal- ventrikolu tax- xellug (LVEF) u insuffiċjenza tal- qalb.
In clinical trials, decreases in LVEF of ≥ 20% and below the lower limit of normal occurred in approximately 2% of SUTENT-treated GIST patients, 4% of cytokine-refractory MRCC patients, 2% of placebo-treated patients.
Fi provi kliniċi, tnaqqis fil- LVEF ta ’ ≥ 20% jew taħt il- limitu t’ isfel tan- normal seħħ f’ madwar 2% ta ’ pazjenti GIST ittrattati b’ SUTENT, 4% ta ’ pazjenti MRCC 4 refrattarja għaċ- ċitokini, 2% ta ’ pazjenti ttrattati bi plaċebo.
These LVEF declines do not appear to have been progressive and often improved as treatment continued.
Dan it- tnaqqis LVEF ma dehrx li kien progressiv u ta ’ spiss tjieb waqt li tkompla t- trattament.
In the treatment-naïve MRCC study, 21% patients on SUTENT and 12% of patients on interferon-α (IFN-α), had an LVEF value below the lower limit of normal.
Fl- istudju MRCC ta ’ trattament fuq pazjenti li qatt ma kienu ħadu qabel din il- kura, 21% ta ’ pazjenti fuq SUTENT u 12% ta ’ pazjenti fuq interferon- α (IFN- α), kellhom il- valur tal- LVEF taħt il- limitu t’ isfel tan- normal.
One (< 1%) patient who received SUTENT was diagnosed with congestive heart failure (CHF).
Pazjent wieħed (< 1%) li ngħata SUTENT kien dijanjożat b’ falliment konġestiv tal- qalb (CHF).
Treatment-related adverse events of ‘ cardiac failure’, ‘ cardiac failure congestive’ or ‘ left ventricular failure’ were reported in 0.7% of patients with solid tumours and 1% of patients treated with placebo.
Reazzjonijiet avversi relatati mat- trattament ta ’ ‘ falliment kardijaku ’, ‘ falliment kardijaku konġestiv ’ jew ‘ falliment ventrikulari xellugi ’ kienu rrapportati f’ 0. 7% ta ’ pazjenti b’ tumuri solidi u 1% ta ’ pazjenti ttrattati bi plaċebo.
All patients had GIST.
Il- pazjenti kollha kellhom GIST.
In the phase 3 GIST study (n=312), treatment-related fatal cardiac events occurred in 1% of patients on each arm of the study (i. e.
Fit- tielet fażi ta ’ l- istudju GIST (n=312), episodji kardijaċi fatali ġraw fi 1% tal- pazjenti f’ kull taqsima ta ’ l- studju (i. e. taqsima b’ SUTENT u bi plaċebo).
In a phase 2 study in cytokine-refractory MRCC patients, 0.9% of patients experienced treatment-related fatal myocardial infarction and in the phase 3 study in treatment-naïve MRCC patients, 0.6% of patients on the IFN-α arm and 0 patients on the
Fi studju tat- tieni fażi ta ’ pazjenti b’ MRCC refrattarja għaċ- ċitokini, 0. 9% tal- pazjenti esperjenzaw attakk tal- qalb fatali, u fit- tielet fażi ta ’ l- istudju f’ pazjenti b’ MRCC li qatt ma kienu trattati qabel, 0. 6% tal- pazjenti fit- taqsima ta ’ IFN- α u 0 pazjenti fit- taqsima tas- SUTENT esperjenzaw attakki tal- qalb fatali.
The relationship, if any, between receptor tyrosine kinase (RTK) inhibition and cardiac function remains unclear.
Ir- relazzjoni, jekk hemm, bejn l- inibizzjoni tar- riċettatur tyrosine kinase (RTK) u l- funzjoni kardijaka tibqa mhix ċara.
Patients who presented with cardiac events within 12 months prior to SUTENT administration, such as myocardial infarction (including severe/ unstable angina), coronary/ peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism were excluded from SUTENT clinical studies.
Pazjenti li ppreżentaw b’ reazzjonijiet kardijaċi, bħal ma huwa infart mijokardjali (inklużi anġina qawwija/ instabbli), graft bajpass ta’ arterja koronarja/ periferali, falliment konġestiv tal- qalb (CHF) sintomatiku, aċċident ċerebrovaskulari u attaki iskemiċi li jgħaddu, jew emboliżmu pulmonari, fi żmien tat- 12- il xahar qabel l- amministrazzjoni, kienu esklużi minn studji kliniċi SUTENT.
Close monitoring for clinical signs and symptoms of CHF should be performed, especially in patients with cardiac risk factors and/ or history of coronary artery disease.
Għandu jsir monitoraġġ mill- qrib għal sinjali u sintomi ta ’ CHF, speċjalment f’ pazjenti li jkollhom fatturi ta ’ riskju kardijaku u/ jew storja ta ’ mard tal- qalb koronarju.
Physicians are advised to weigh this risk against the potential benefits of the drug.
It- tobba huma avżati li jiżnu dan ir- riskju kontra s- siwi potenzjali tal- mediċina.
These patients should be carefully monitored for clinical signs and symptoms of CHF while receiving SUTENT.
Dawn il- pazjenti għandhom ikunu sorveljati bir- reqqa għal sinjali u sintomi kliniċi ta ’ CHF waqt li jkunu qegħdin jieħdu SUTENT.