qanastek/EMEA-V3 huggingface dataset:
If you have any questions about how Tasigna works or why it has been prescribed for you, ask your doctor.
Jekk għandek xi mistoqsijiet dwar kif jaħdem Tasigna jew għaliex ordnawuwlek, staqsi lit- tabib tiegħek.
BEFORE YOU TAKE TASIGNA
QABEL MA TIEĦU TASIGNA
Follow all the doctor’ s instructions carefully.
Segwi l- istruzzjonijiet kollha tat- tabib b’ attenzjoni.
They may differ from the general information contained in this leaflet.
Jistgħu jkunu differenti mit- tagħrif ġenerali li hawn f’ dan il- fuljett.
29 Do not take Tasigna
Tieħux Tasigna
- if you are allergic (hypersensitive) to nilotinib or any of the other ingredients of Tasigna listed
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal nilotinib jew sustanzi oħra ta ’
at the end of this leaflet.
Tasigna li huma elenkati fl- aħħar ta ’ dan il- fuljett.
If you think you may be allergic, tell your doctor before taking Tasigna.
Jekk taħseb li inti allerġiku/ a, għid lit- tabib tiegħek qabel ma tieħu Tasigna.
Take special care with Tasigna
Oqgħod attent ħafna b’ Tasigna
- if you have a heart disorder, such as an abnormal electrical signal called “ prolongation of the
- jekk int għandek disturb tal- qalb, bħall sinjal elettriku anormali imsejjaħ “ titwil ta ’ l- intervall
QT interval”.
QT ”.
- if you are being treated with medicines that affect the heart beat (anti-arrhythmics) or the liver
- jekk qed tingħata kura b’ mediċini li jeffettwawlek it- tħabbit tal- qalb (anti- arritmiċi) jew il -
(see Taking other medicines).
fwied (ara Meta tieħu mediċini oħra).
- if you suffer from lack of potassium or magnesium.
- jekk tbati minn nuqqas ta ’ potassium jew magnesium.
- if you have been treated with a medicine of the type called anthracyclines (frequently used in
- jekk ingħatajt kura b’ mediċini tat- tip imsejjħa antraċiklini (li jintużaw ta ’ spiss f’ terapija għall -
leukaemia therapy).
lewkemija).
- if you have a liver or pancreas disorder.
- jek għandek disturb fil- fwied jew fil- frixa.
- if you are being treated with medicines that affect your stomach acidity (see Taking other
- jekk qed tiġi kkurat b’ mediċini li jeffettwaw l- aċidu fl- istonku tiegħek (ara Meta tieħu mediċini
medicines).
oħra).
If any of these apply to you, tell your doctor.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek.
Taking other medicines Tasigna may interfere with some other medicines.
Meta tieħu mediċini oħra Tasigna jista ’ jinterferixxi ma ’ xi mediċini oħrajn.
Tell your doctor or pharmacist before taking Tasigna if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek qabel tieħu Tasigna jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
This includes in particular: • antiarrhythmics – used to treat irregular heart beat; • chloroquine, halofantrine, clarithromycin, haloperidol, methadone - medicines that may have an unwanted effect on the function of the heart; • ketoconazole, itraconazole, voriconazole, moxifloxacin, clarithromycin, telithromycin – used to treat infections; • ritonavir – a medicine from the class “ antiproteases” used to treat HIV; • carbamazepine, phenobarbital, phenytoin – used to treat epilepsy; • rifampicin – used to treat tuberculosis; • St.
Dan jinkludi b’ mod partikolari: • antiarritmiċi – li jintużaw għall- kura ta ’ meta l- qalb ma tħabbatx regolari; • chloroquine, halofantrine, clarithromycin, haloperidol, methadone – mediċini li jista ’ jkollhom effett mhux mixtieq fuq il- funzjoni tal- qalb; • ketoconazole, itraconazole, voriconazole, moxifloxacin, clarithromycin, telithromycin – jintużaw għall- kura ta ’ infezzjonijiet; • ritonavir – mediċina mill- klassi “ antiproteażi ” li tintuża għall- kura ta ’ l- HIV; • carbamazepine, phenobarbital, phenytoin – jintużaw għall- kura ta ’ l- epilessija; • rifampicin – jintuża għall- kura tat- tuberikulożi; • St.
John’ s Wort – a herbal product used to treat depression and other conditions (also known as Hypericum perforatum); • midazolam – used to relieve anxiety before surgery; • warfarin – used to treat blood coagulation disorders (such as blood clots or thromboses); • astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine); • antacids, H2 blockers, proton pump inhibitors – used to suppress stomach acidity.
John’ s Wort – prodott magħmul mill- ħxejjex li jintuża għall- kura ta ’ dipressjoni u kundizzjonijiet oħra (magħruf ukoll bħala Hypericum perforatum); • midazolam – jintuża biex iserraħ mill- ansjetà qabel operazzjoni; • warfarin – tintuża għall- kura ta ’ disturbi tal- koagulazzjoni tad- demm (bħall demm magħqud jew trombożi); • astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil jew ergot alkaloids (ergotamine, dihydroergotamine); • antaċidi, imblukkaturi H2, inibituri tal- pompi tal- protoni – jintużaw biex jissopprimu l- aċidità fl - istonku.
These medicines should be avoided during your treatment with Tasigna.
Dawn il- mediċini għandhom jiġu evitati waqt il- kura b’ Tasigna.
If you are taking any of these, your doctor might prescribe other alternative medicines.
Jekk qed tieħu xi wieħed minn dawn, it- tabib tiegħek jista ’ jordnalek xi mediċini oħrajn.
You should also tell your doctor if you are already taking Tasigna and you are prescribed a new medicine that you have not taken previously during Tasigna treatment.
Għandek ukoll tgħid lit- tabib tiegħek jekk diġà qed tieħu Tasigna u jordnawlek mediċina ġdida li ma kontx qed tieħu qabel waqt il- kura b’ Tasigna.
Taking Tasigna with food and drink • Do not take Tasigna with food.
31 Meta tieħu Tasigna ma ’ l- ikel u max- xorb • Tieħux Tasigna ma ’ l- ikel.
Take the capsules at least 2 hours after any food and then wait at least 1 hour before eating again.
Ħu l- kapsuli mill- anqas sagħtejn wara kwalunkwe ikel u imbagħad stenna mill- anqas siegħa qabel terġa tiekol.
For more information, see under “ When to take Tasigna” in section 3. • Do not drink grapefruit juice or eat grapefruit.
Għal aktar tagħrif, ara taħt “ Meta għandek tieħu Tasigna ” f’ sezzjoni 3. • M’ għandekx tixrob meraq tal- grejpfrut jew tiekol grejpfrut.
It may increase the amount of Tasigna in the blood, possibly to a harmful level.
Tista’ żżid l- ammont ta ’ Tasigna fid - demm tiegħek, u dan jista ’ jkun għall- livell li jgħamillek il- ħsara.
Older people (age 65 years and over) Tasigna can be used by people aged 65 years and over at the same dose as for other adults.
Pazjenti aktar anzjani (età 65 sena ’ l fuq) Tasigna jista ’ jintuża minn persuni li għandhom 65 sena u aktar bl- istess doża bħall ta ’ adulti oħrajn.
30 Pregnancy and breast-feeding • Tasigna is not recommended during pregnancy unless clearly necessary.
Tqala u Treddigħ • Tasigna mhux rakkomandat waqt it- tqala sakemm ma jkun hemm bżonn ċar.
If you are pregnant or think that you may be, tell your doctor who will discuss with you whether you can take Tasigna during your pregnancy. • Women who might get pregnant are advised to use effective contraception during treatment. • Breast-feeding is not recommended during treatment with Tasigna.
Jekk ħriġt tqila jew taħseb li tista ’ tkun, għid lit- tabib tiegħek li se jiddiskuti miegħek jekk tistax tieħu Tasigna waqt it- tqala. • Nisa li jistgħu joħorġu tqal huma konsiljati li jużaw kontraċezzjoni effettiva waqt il- kura. • It- treddigħ mhux rakkomandat waqt kura b’ Tasigna.
Driving and using machines If you experience side effects (such as dizziness or visual disorders) with a potential impact on the ability to safely drive or use any tools or machines after taking Tasigna, you should refrain from these activities until the effect has disappeared.
Sewqan u tħaddim ta ’ magni Jekk tħoss xi effetti sekondarji (bħall sturdament jew disturbi viżivi) li jista ’ jkollhom impatt fuq il- ħila biex issuq b’ mod sigur jew tuża kwalunkwe magni wara li tieħu Tasigna, m’ għandekx tagħmel dawn l - attivitajiet sakemm l- effett ikun għeb.
Important information about some of the ingredients of Tasigna This medicine contains lactose (also known as milk sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Tasigna Din il- mediċina fiha lactose (magħruf ukoll bħala zokkor tal- ħalib).
HOW TO TAKE TASIGNA
KIF GĦANDEK TIEĦU TASIGNA
Always take Tasigna exactly as your doctor has told you.
Dejjem għandek tieħu Tasigna eżatt skond il- parir tat- tabib.
How much Tasigna to take • The starting dose is 800 mg per day.
Kemm għandek tieħu Tasigna • Id- doża tal- bidu hija 800 mg kuljum.
This dose is achieved by taking two capsules of 200 mg twice a day.
Din id- doża tinkiseb billi jittieħdu żewġ kapsuli ta ’ 200 mg darbtejn kuljum.
When to take Tasigna Take the capsules: • twice a day (approximately every 12 hours); • at least 2 hours after any food; • then wait 1 hour before eating again.
Meta għandek tieħu Tasigna Ħu l- kapsuli • darbtejn kuljum (bejn wieħed u ieħor kull 12- il siegħa); • mill- anqas sagħtejn wara kwalunkwe ikel; • imbagħad stenna siegħa 1 qabel terġa tiekol.
If you have questions about when to take Tasigna, talk to your doctor or pharmacist.
Jekk għandek xi mistoqsijiet dwar meta għandek tieħu Tasigna, tkellem mat- tabib jew spiżjar tiegħek.
Taking Tasigna at the same time each day will help you remember when to take your capsules.
Jekk tieħu Tasigna fl- istess ħin kuljum dan ser jgħinek biex tiftakar meta għandek tieħu l- kapsuli tiegħek.
How to take Tasigna • Swallow the capsules whole with water. • Do not open the capsules. • Do not take any food together with the capsules.
Kif għandek tieħu Tasigna • Ħu l- kapsuli sħaħ ma ’ l- ilma. • Tiftaħx il- kapsuli. • Tieħu l- ebda ikel mal- kapsuli.
How long to take Tasigna Continue taking Tasigna every day for as long as your doctor tells you.
Kemm għandek iddum tieħodhom Kompli ħu Tasigna kuljum sakemm jgħidlek it- tabib.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Din hija kura fit- tul. It- tabib tiegħek ser jimmonitorja l- kundizzjoni tiegħek b’ mod regolari sabiex jara li l- kura qed ikollha l- effett mixtieq.
If you have questions about how long to take Tasigna, talk to your doctor.
Jekk għandek xi mistoqsijiet dwar kemm għandek iddum tieħu Tasigna, tkellem mat- tabib tiegħek.
If you take more Tasigna than you should If you have taken more Tasigna than you should have, or if someone else accidentally takes your capsules, contact a doctor or hospital for advice straight away.
32 Jekk tieħu Tasigna aktar milli suppost Jekk ħadt aktar Tasigna milli suppost, jew jekk xi ħadd ħa l- kapsuli tiegħek b’ aċċident, għamel kuntatt mat- tabib jew l- isptar tiegħek għall- parir minnufih.
Show them the pack of capsules and this package leaflet.
Urihom il- pakkett tal- kapsuli u l- fuljett ta ’ tagħrif.
Medical treatment may be necessary.
Jista ’ jkun hemm bżonn attenzjoni medika.
If you forget to take Tasigna If you miss a dose, take your next dose as scheduled.
Jekk tinsa tieħu Tasigna Jekk taqbiżlek doża, ħu d- doża li jmiss kif skedat.
Do not take a double dose to make up for the forgotten capsules.
M’ għandekx tieħu doża doppja biex tpatti għal kull kapsula li tkun insejt tieħu.
31 If you stop taking Tasigna Do not stop taking Tasigna unless your doctor tells you to.
Jekk tieqaf tieħu Tasigna Tieqafx tieħu Tasigna sakemm ma jgħidlekx it- tabib biex tagħmel hekk.
Like all medicines, Tasigna can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Tasigna jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Fil- parti l- kbira l- effetti sekondarji huma ħfief għal moderati u ġeneralment jgħaddu wara ftit jiem sa ftit ġimgħat ta ’ kura.
Some side effects could be serious.
Xi ftit effetti sekondarji jistgħu jkunu serji.
These side effects are common, uncommon or have been reported in very few patients. • rapid weight gain, swelling of hands, ankles, feet or face • chest pain, high blood pressure, irregular heart rhythm (signs of heart disorders) • difficulty breathing, cough, wheezing, swelling of the feet or legs (signs of lung disorders) • fever, sore throat, mouth sores, weakness, bruising, frequent infections (signs of blood disorders) • weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling or hearing things that are not there (signs of nervous system disorders) • thirst, dry skin, irritability, dark urine, decreased urine output (signs of kidney disorders) • blurred vision, loss of vision, visible bleeding in white of eye (signs of eye disorders) • swelling and pain in one part of the body (signs of clotting within a vein) • abdominal pain, nausea, vomiting of blood, black stools, constipation, swollen abdomen (signs of gastrointestinal disorders) • yellow skin and eyes, nausea, loss of appetite, light-coloured urine (signs of liver disorders) • rash, painful red lumps, pain in joints and muscles (signs of skin disorders) • excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of high level of sugar in the blood) If you get any of these, tell your doctor straight away.
Dawn l- effetti sekondarji huma komuni, mhux komuni jew kienu rrappurtati f’ numru żgħir ħafna ta ’ pazjenti. • żieda mgħaġġla fil- piż, nefħa ta ’ l- idejn, għekiesi, saqajn jew wiċċ • uġigħ fis- sider, presjoni għolja, ritmu irregolari tal- qalb (sinjali ta ’ disturbi tal- qalb) • tbatija biex tieħu n- nifs, sogħla, tħarħir, nefħa tas- saqajn jew riġlejn (sinjali ta ’ disturbi tal - pulmun) • deni, grieżem misluħin, selħiet fil- ħalq, dgħjufija, tbenġil, infezzjonijiet frekwenti (sinjali ta ’ disturbi tad- demm) • dgħjufija jew paraliżi tar- riġlejn, dirgħajn jew tal- wiċċ, tbatija biex titkellem, uġigħ ta ’ ras qawwi, tara, tħoss jew tisma affarjiet li ma jkunux hemm (sinjali ta ’ disturbi fis- sistema nervuża) • għatx, ġilda xotta, irritabilità, awrina skura, żieda fil- volum ta ’ awrina (sinjali ta ’ disturbi fil - kliewi) • vista mċajpra, telf tal- vista, jidher id- demm fl- abjad ta ’ l- għajn (sinjali ta ’ disturbi fl- għajnejn) • nefħa u uġigħ f’ xi parti tal- ġisem (sinjal li għaqad id- demm f’ xi vina) • uġigħ fl- addome, dardir, rimettar tad- demm, ippurgar iswed, stitikezza, addome minfuħ (sinjali ta ’ disturbi gastro- intestinali) • ġilda u għajnejn sofor, dardir, telf ta ’ l- aptit, awrina ċara fil- kulur (sinjali ta ’ mard tal- fwied) • raxx, għoqiedi ħomor li jweġgħu, ugigħ fil- ġogi u l- muskoli (sinjali ta ’ disturbi tal- ġilda) • għatx eċċessiv, produzzjoni ta ’ volum kbir ta ’ awrina, żieda fl- aptit u telf tal- piż, għeja (sinjali ta ’ livell għoli ta ’ zokkor fid- demm) Jekk ikollok xi wieħed minn dawn, għid lit- tabib tiegħek minnufih.
These effects may affect more than 10 in every 100 patients. • nausea, constipation, diarrhoea • headache • tiredness • itching, rash • low level of white blood cells, red blood cells or platelets and high level of lipase in the blood (changes in blood test results) If any of these affects you severely, tell your doctor.
Dawn jistgħu jeffettwaw aktar minn 10 f’ kull 100 pazjent. • dardir, stitikezza, dijarea • uġigħ ta ’ ras • għeja • ħakk, raxx • livell baxx ta ’ ċelluli bojod tad- demm, ċelluli ħomor tad- demm jew plejtlits u livell għoli ta ’ lipase fid- demm (bidliet fir- riżultati tat- testijiet tad- demm) Jekk xi wieħed minn dawn jeffettwawk b’ mod sever, għid lit- tabib tiegħek.
Some side effects are common.
33 Xi effetti sekondarji huma komuni.
These effects may affect between 1 and 10 in every 100 patients. • vomiting, abdominal pain, stomach discomfort after meals, flatulence • bone pain, pain in joints, muscle spasms, muscle pain • skin reddening, dry skin • loss of appetite, weight decrease or increase • hair loss • insomnia • night sweats, excessive sweating, hot flushes • dizziness, generally feeling unwell; spinning sensation • tingling or numbness • voice disorder
Dawn jistgħu jeffettwaw bejn 1 u 10 f’ kull 100 pazjent. • rimettar, uġigħ fl- addome, fastidju fl- istonku wara l- ikel, tifwieq • uġigħ fl- għadam, uġigħ fil- ġogi, spażmi tal- muskoli, uġigħ fil- muskoli • ġilda tiħmar, ġilda xotta • titlef l- aptit, tnaqqas jew iżżid fil- piż • titlef ix- xagħar • tbati biex torqod • tgħereq matul il- lejl, tgħereq b’ mod eċċessiv, fwawar ta ’ sħana • sturdament, tħossok ma tiflaħx b’ mod ġenerali, tħoss kollox idur bik • tingiż jew tnemnim • disturbi tal- vuċi • testijiet tal- funzjoni tal- fwied mhux normali u bidliet oħrajn fir- riżultati tat- testijiet tad- demm bħall livell għoli ta ’ potassium jew livell baxx ta ’ magnesium. • palpitazzjonijiet (sensazzjoni ta ’ qalb tħabbat bil- għaġġla) Jekk xi wieħed minn dawn jeffettwawk b’ mod sever, għid lit- tabib tiegħek.
Some side effects are uncommon.
Xi effetti sekondarji mhumiex komuni.
These effects may affect less than 1 in every 100 patients. • decreased or increased skin sensitivity • eye irritation, swelling, discharge, itching or redness, dry eye (signs of eye disorders) • dry mouth • heartburn, swelling or bloating of the abdomen • breast pain • nose bleed • increased appetite • anxiety • depression • difficulty and pain when urinating, exaggerated sense of needing to urinate • inability to achieve or maintain an erection • breast enlargement in men • flu-like symptoms • trembling • decreased sharpness of vision • frequent urine output • abnormal kidney function test results • severe headache often accompanied by nausea, vomiting and sensitivity to light If any of these affects you severely, tell your doctor.
Dawn l- effetti jistgħu jeffettwaw anqas minn 1 f’ kull 100 pajent. • tnaqqis jew żieda tas- sensittività tal- ġilda • irritazzjoni tal- għajnejn, nefħa, tnixxija, ħakk jew ħmura fl- għajn, għajnejn xotti (sinjali ta ’ disturbi fl- għajnejn) • ħalq xott • ħruq ta ’ stonku, nefħa jew imbulmar fl- addome • uġigħ tas- sider • tinfaraġ mill- imnieħer • żieda ta ’ l- aptit • ansjetà • dipressjoni • tbati u tweġġa meta tgħaddi l- awrina, tħoss b’ mod eżaġerat il- bżonn li tgħaddi l- awrina • ma tkunx tista ’ tikseb jew iżżomm erezzjoni • jikber is- sider fl- irġiel • sintomi bħall ta ’ l- influwenza • tregħid • tnaqqis f’ kemm tista ’ tara ċar • tgħaddi l- awrina ta ’ spiss • riżultati tat- testijiet tal- funzjoni tal- kliewi jiġu anormali • uġigh ta ’ ras sever ħafna drabi b’ dardir, rimettar u sensittività għad- dawl Jekk xi wieħed minn dawn jeffettwawk b’ mod sever, għid lit- tabib tiegħek.
The following other side effects have been reported in very few patients treated with Tasigna: • confusion, disorientation • sensation of numbness or tingling in fingers and toes • increased sensitivity of the eyes or the skin to light • eye pain or redness, pain, swelling and itching of the eyelids • difficulty hearing, ear pain • joint stiffness, muscle weakness • unconsciousness • blood in urine • weight gain, tiredness, hair loss, muscle weakness, feeling cold If any of these affects you severely, tell your doctor.
L- effetti sekondarji oħrajn li kienu rrappurtati f’ numru żgħir ħafna ta ’ pazjenti kkurati b’ Tasigna: • konfużjoni, diżorjentament • sensazzjoni ta ’ tnemnim jew tingiż fis- swaba ta ’ l- idejn u saqajn • żieda tas- sensittività ta ’ l- għajnejn jew tal- ġilda għad- dawl • uġigħ jew ħmura fl- għajnejn, uġigħ, nefħa u ħakk f’ tebqet il- għajn • tbatija biex tisma ’, uġigħ fil- widnejn • ebusija tal- ġogi, dgħjufija tal- muskoli • telf mis- sensi • demm fl- awrina • żieda fil- piż, għeja, telf tax- xagħar, tħoss il- kesħa Jekk xi wieħed minn dawn jeffettwawk b’ mod sever, għid lit- tabib tiegħek.
HOW TO STORE TASIGNA
KIF TAĦŻEN TASIGNA
• Keep out of the reach and sight of children. • Do not use Tasigna after the expiry date which is stated on the carton and blister foil.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax Tasigna wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- fojl tal- folja.
The expiry date refers to the last day of that month. • Do not store above 30°C. • Store in the original package in order to protect from moisture. • Do not use any pack that is damaged or shows signs of tampering.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar. • Taħżinx f’ temperatura ’ l fuq minn 30°C • Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità. • Tuża l- ebda pakkett li jkun bil- ħsara jew juri sinjali ta ’ tbabis.
What Tasigna contains
X’ fih Tasigna
- The active substance is nilotinib.
- Is- sustanza attiva hi nilotinib.
Each capsule contains 200 mg nilotinib (as hydrochloride
Kull kapsula fiha 200 mg nilotinib (bħala hydrochloride
monohydrate).
monohydrate).
- The other ingredients are lactose monohydrate, crospovidone, poloxamer 188, silica colloidal
- Is- sustanzi l- oħra huma lactose monohydrate, crospovidone, poloxamer 188, silica colloidal
anhydrous, magnesium stearate.
anhydrous, magnesium stearate.
The capsule shell is composed of gelatin, titanium dioxide (E171), yellow iron oxide (E172) and, shellac, red iron oxide (E172) and soya lecithin (E322) for stamping of the imprint.
Il- qoxra tal- kapsula hija magħmula minn gelatin, titanium dioxide (E171), yellow iron oxide (E172) u shellac, red iron oxide (E172) u soya lecithin (E322) għat- timbrar tat- timbru.
What Tasigna looks like and contents of the pack Tasigna is supplied as hard capsules.
Id- Dehra ta ’ Tasigna u l- kontenuti tal- pakkett Tasigna jiġi bħala kapsuli iebsin.
The capsules are light yellow.
Il- kapsuli huma sofor ċari.
A red imprint is stamped on each capsule (“ NVR/ TKI”).
Timbru aħmar huwa stampat fuq kull kapsula (“ NVR/ TKI ”).
Tasigna is available in weekly and monthly packs: • The weekly pack contains 28 capsules. • The monthly pack contains 112 capsules (4x28).
Tasigna jiġi f’ pakketti ta ’ ġimgħa jew ta ’ xahar: • Il- pakkett ta ’ ġimgħa fih 28 kapsula. • Il- pakkett ta ’ xahar fih 112- il kapsula (4x28).
A monthly pack consists of 4 individual weekly packs.
Pakkett ta ’ xahar għandu 4 pakketti individwali għal kull ġimgħa.
Not all packs may be marketed in your country.
Jista ’ jkun li mhux il- pakketti kollha jkunu mqegħda fis- suq f’ pajjiżek.
Č eská republika Novartis s. r. o.
35 Česká republika Novartis s. r. o.
This document is a summary of the European Public Assessment Report (EPAR).
Sommarju ta ’ l- EPAR għall- pubbliku Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea (EPAR).
What is Tasmar?
X’ inhu Comtess?
Tasmar is a medicine containing the active substance tolcapone.
Tasmar hu mediċina li jkun fiha s- sustanza attiva tolcapone.
It is available as hexagonal tablets with 100 mg (pale yellow) or 200 mg (yellow-orange) of tolcapone.
Jiġi bħala pilloli eksagonali b’ 100 mg (isfar ċar) jew 200 mg (isfar fl- oranġjo) tolcapone.
What is Tasmar used for?
Għal xiex jintuża Tasmar?
Tasmar is used to treat patients with Parkinson’ s disease.
Tasmar jintuża fit- trattament ta ’ pazjenti bil- marda ta ’ Parkinson.
Parkinson’ s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Il- marda ta ’ Parkinson hi marda progressiva tal- moħħ li tikkawża rogħda, tnaqqis fil- ħeffa taċ- ċaqliq u ebusija tal- muskoli.
Tasmar is used together with other standard treatments for Parkinson’ s disease (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patients have ‘ fluctuations’ towards the end of the period between two doses of their standard combination.
Tasmar jintuża flimkien ma ’ trattamenti oħra standard għall- marda ta ’ Parkinson (jew kombinazzjoni ta ’ levodopa u benserazide jew levodopa u carbidopa) meta l- pazjenti jkollhom ‘ tibdiliet f’ daqqa ’ lejn tmiem il- perjodu bejn iż- żewġ dożi tal- kombinazzjoni standard.
Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘ on’ and able to move, and being ‘ off’ and immobile.
It- tibdiliet f’ daqqa huma assoċjati ma ’ tnaqqis fl- effetti ta ’ levodopa, meta l- pazjent jesperjenza tibdiliet f’ daqqa minn li jkun ‘ on ’ u kapaċi jimxi, u jkun ‘ off ’ u jsibha diffiċli biex jimxi minn naħa għal oħra.
Tasmar is only used when patients do not respond, or cannot take other medicines of the same type.
Tasmar jintuża biss meta l- pazjenti ma jirrispondux, jew ma jkunux jistgħu jieħdu mediċini oħra ta ’ dan it- tip.
How is Tasmar used?
Kif jintuża Tasmar?
Tasmar should only be prescribed and supervised by a doctor who has experience in the management of advanced Parkinson's disease.
Tasmar għandu jiġi preskritt u sorveljat biss minn tabib li jkollu esperjenza fil- ġestjoni tal- marda tal - Parkinson avvanzata.
It is always given with levodopa and benserazide or with levodopa and carbidopa.
Jingħata dejjem ma ’ levodopa u benserazide jew ma ’ levodopa u carbidopa.
The recommended dose is 100 mg three times a day.
Id - doża rakkomandata hi 100 mg tliet darbiet kuljum.
The tablets should be swallowed whole.
Il- pilloli għandhom jinbelgħu sħaħ.
The dose of Tasmar may be increased to 200 mg three times a day but only when the benefit expected outweighs the risk of liver injury.
Meta l- pazjenti jżidu Tasmar mal- mediċina li jkunu diġà qed jieħdu għal kontra l- marda tal- Parkinson, għandhom jiġu mgħarrfa li jista ’ jkollhom xi effetti sekondarji ta ’ levodopa għalkemm dawn ħafna drabi jistgħu jitnaqqsu għal 200 mg tliet darbiet kuljum iżda biss meta l- benefiċċju antiċipat jegħleb ir- riskju ta ’ ħsara fil- fwied.
If after three weeks, no substantial benefit has been seen, treatment with Tasmar should be stopped.
Jekk wara tliet ġimgħat ma jkunx deher benefiċċju sostanzjali, it - trattament b’ Tasmar għandu jitwaqqaf.
Tasmar should not be given to patients with liver disease.
Tasmar m’ għandux jingħata lil pazjenti bil- mard tal- fwied.
Liver function should be checked before starting treatment with Tasmar and then monitored every two weeks for the first year of treatment.
Il - funzjoni tal- fwied għandha tiġi ċċekkjata qabel jinbeda t- trattament inizjali b’ Tasmar u mbagħad jiġi sorveljat kull ġimagħtejn għall- ewwel sena tat- trattament.
How does Tasmar work?
Kif jaħdem Tasmar?
In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Fil- pazjenti bil- marda tal- Parkinson, iċ- ċelloli fil- moħħ li jipproduċu n- newrotrażmettitur magħruf bħala dopamina jibdew imutu u l- ammont ta ’ dopamina fil- moħħ tonqos.
The patients then lose their ability to control their movements reliably.
Is- sustanza attiva f’ Tasmar, tolcapone, taħdem billi treġġa ’ għan- normal il- livelli ta ’ dopamina fil- partijiet tal- moħħ li jikkontrollaw il- moviment u l - ko- ordinazjoni.
The active substance in Tasmar, tolcapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Jaħdem biss meta jittieħed ma ’ levodopa, kopja tan- newrotrażmettitur dopamine, li jista ’ jinbela ’.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Tasmar?
Tasmar was originally studied in a total of 594 patients, in two 13-week studies and one six-week study.
Tasmar oriġinarjament b’ kollox ġie studjat fuq 594 pazjent, f’ żewġ studji ta ’ 13- il ġimgħa kull wieħed u studju wieħed ta ’ sitt ġimgħat.
All of the studies compared the effectiveness of adding Tasmar with that of adding placebo (a dummy treatment) to the patient ’ s existing medication (levodopa and either carbidopa or benserazide).
L- istudji kollha qabblu l- effettività taż- żieda ta ’ Tasmar ma ’ dak taż - żieda ta ’ plaċebo (trattament finta) mal- medikazzjoni eżistenti tal- pazjent (levodopa u jew carbidopa jew benserazide).
The main measure of effectiveness was the time spent in the ‘ off’ or in the ‘ on’ state (the time when levodopa is not [off] or is [on] controlling the symptoms of Parkinson’ s disease).
Il- mezz ewlieni tal- kejl ta ’ l- effettività kien iż- żmien li l- pazjenti kienu fi stat ‘ off ’ jew fl- istat ‘ on ’ state (il- ħin meta levodopa ma jkunx [off] jew ikun [on] li jikkontrolla s- sintomi tal - marda ta ’ Parkinson).
Tasmar has been further studied in a ‘ switch’ study in 150 patients.
Tasmar ġie studjat ukoll fi studju ieħor tal - ‘ qlib ta ’ l- istat ’ f’ 150 pazjent.
These patients were already receiving a combination of levodopa and entacapone (another medicine that blocks COMT).
Dawn il- pazjenti kienu diġà qed jieħdu kombinazzjoni ta ’ levodopa u entacapone (mediċina oħra li timblokka s- COMT).
The study compared the effectiveness of continuing with entacapone or switching to Tasmar.
L- istudju qabbel l- effettività tat- tkomplija b’ entacapone jew il- qlib għal Tasmar.
The main measure of effectiveness was the proportion of patients with an increase in ‘ on ’ time of one hour or more, over the three weeks following the switch.
Il- mezz ewlieni tal- kejl ta ’ l - effettività kien il- proporzjoni ta ’ pazjenti b’ żieda fil- ħin ‘ on ’ ta ’ siegħa jew iktar, matul tliet ġimgħat jew iktar wara l- bidla.
What benefit has Tasmar shown during the studies?
X’ inhuma l- benefiċċji ta ’ Tasmar li ntwerew f’ dawn l- istudji?
The initial studies showed that Tasmar was more effective than placebo.
L- istudji inizjali wrew li Tasmar kien iktar effettiv mill- plaċebo.
There was a reduction of about 20 to 30% in ‘ off ’ time in patients taking Tasmar.
Kien hemm tnaqqis ta ’ madwar bejn 20 u 30% fil- ħin li fih kienu ‘ off ’ il- pazjenti li kienu qed jieħdu Tasmar.
In the switch study, there were more patients who responded to treatment with Tasmar (53%) than to treatment with entacapone (43%).
Fl- istudju tal- qlib, kiem hemm iktar pazjenti li rrispondew għat- trattament b’ Tasmar (53%) milli għat - trattament b’ entacapone (43%).
What is the risk associated with Tasmar?
X’ inhu r- riskju assoċjat ma ’ Tasmar?
The most common side effects with Tasmar (seen in more than 1 patient in 10) are nausea (feeling sick), anorexia (loss of appetite), diarrhoea, dyskinesia (uncontrollable movements), dystonia (muscle spasms), headache, dizziness, sleep disorders, excessive dreaming, somnolence (sleepiness), confusion, hallucination (seeing things that are not there) and orthostatic complaints (dizziness on standing).
L- iktar effetti sekondarji komuni ma ’ Comtess (li dehru f’ bejn pazjent wieħed u 10 minn kull 100) huma d- diskinesja (movimenti inkontrollabbli), id- dardir u tibdil fil- kulur ta ’ l- awrina li ma jagħmilx ħsara, l- anoressija (nuqqas ta ’ aptit) id- dijarea, id- distonja (spasmi fil- muskoli), l- uġigħ ta ’ ras, l - isturdament, diżordnijiet ta ’ l- irqad, ħolm eċċessiv, somnolenza (ngħas), konfużjoni, alluċinazzjonijiet (jidhru affarijiet li ma jkunux hemm) u sturdament ortostatiku (li jseħħ meta wieħed iqum bilwieqfa).
Tasmar can cause liver injury, which can rarely be fatal, and doctors should monitor patients very carefully during treatment.
Tasmar jista ’ jikkawża ħsara fil- fwied, li rarament jista ’ jkun fatali, u t- tobba għandhom jissorveljaw lill- pazjenti bir- reqqa waqt it- trattament.
For the full list of all side effects reported with Tasmar, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Tasmar, ara l- Fuljett ta ’ Tagħrif.
Tasmar should not be used in patients who may be hypersensitive (allergic) to tolcapone or any of the other ingredients.
Tasmar m’ għandux jintuża f’ persuni li jistgħu jkunu allerġiċi għal entacapone jew xi ingredjent ieħor.
It should not be used in patients with: • signs of liver disease or increased liver enzymes, • phaeochromocytoma (a tumour of the adrenal gland), • a history of neuroleptic malignant syndrome (a dangerous nervous disorder usually caused by antipsychotic medicines), rhabdomyolysis (breakdown of muscle fibres) or hyperthermia (heat stroke), • severe dyskinesia.
Comtess m’ għandux jintuża f’ pazjenti li jkollhom: • sinjali ta ’ mard tal- fwied jew żieda fl- enżimi tal- fwied, • phaeochromocytoma (tumur tal- glandola adrenali), • epidodju jew iktar tas- sindromu newrolettiku malinn (diżorni perikoluża tan- nervituri kkawżata minn mediċini antipsikotiċi) jew rhabdomyolysis (tkissir tal- fibri tal- muskoli) jew żieda eċċessiva fit- temperatura, • diskinesja severa.
Why has Tasmar been approved?
Għaliex ġie approvat Tasmar?
The Committee for Medicinal products for Human Use (CHMP) decided that Tasmar’ s benefits are greater than its risks in combination with levodopa/ benserazide or levodopa/ carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’ s disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Tasmar huma ikbar mir- riskji tiegħu meta użat bħala żieda ma ’ kombinazzjonijiet levodopa/ benserazide jew levodopa/ carbidopa għall- użu f’ pazjenti li jkollhom il- marda tal- Parkinson idjopatika li tirrispondi għal levodopa u flutwazzjonijiet motorili fil- moviment, li ma jkunux irrispondew jew li jkunu intolleranti għall- inibituri l- oħra ta ’ COMT.
The Committee recommended that Tasmar be given marketing authorisation.
Il- Kumitat irrakkomanda li Tasmar jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Tasmar:
Tagħrif ieħor dwar Tasmar:
The European Commission granted a marketing authorisation valid throughout the European Union for Tasmar on 27 August 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Tasmar valida għall- Unjoni Ewropea kollha fis- 27 ta ’ Awissu 1997.
Because of reports of fatal liver injury, the marketing authorisation was suspended on 11 December 1998.
Minħabba rapporti ta ’ korriment fatali fil- fwied, l - awtorizzazzjoni għat- tqegħid fis- uq ġiet sospiża fil- 11 ta ’ Diċembru 1998.
The suspension was lifted on 31 August 2004.
Is- sospensjoni tneħħiet fil - 31 ta ’ Awissu 2004.
The marketing authorisation holder is Valeant Pharmaceuticals Ltd.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa Valeant Pharmaceuticals Ltd.
The full EPAR for Tasmar is available here.
L- EPAR sħiħ għal Tasmar huwa disponibbli minn hawn.
What is TAXOTERE?
X’ inhu TAXOTERE?
TAXOTERE is a concentrate and solvent to be made up into a solution for infusion (drip into a vein).
TAXOTERE huwa konċentrat u solvent li jsiru soluzzjoni għal infużjoni (drip ġol- vina).
It contains the active substance docetaxel.
Fih is - sustanza attiva docetaxel.
What is TAXOTERE used for?
Għal x' hiex jintuża TAXOTERE?
TAXOTERE is an anticancer medicine.
TAXOTERE hu mediċina kontra l- kanċer.
It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated. • non-small cell lung cancer.
Dan jiddependi mit- tip u l- istadju tal - kanċer fis- sider li jkun qed jiġi trattat. • kanċer tal- pulmun mhux ta ’ l- għamla ta ’ ċelluli żgħar.
It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer. • prostate cancer, when the cancer does not respond to hormonal treatment.
Jista ’ jintuża ma ’ cisplatin (mediċina oħra contra l- kanċer) f’ pazjenti li ma jkunux għadhom irċevew l- ebda trattament għall- kanċer tagħhom. • kanċer tal- prostata, meta l- kanċer ma jirrispondix għall- kura bl- ormoni.
It is used with prednisone or prednisolone (anti-inflammatory medicines). • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Jista ’ jintuża ma ’ prednisone jew prednisolone (mediċini anti- infjammatorji). • adenocarcinoma ta ’ l- istonku (tip ta ’ kanċer fl- istonku) f’ pazjenti li għadhom ma rċevew l- ebda trattament għall- kanċer tagħhom.
It is used with cisplatin and 5-fluorouracil (other anticancer medicines). • head and neck cancer in patients whose cancer is advanced.
Jista ’ jintuża ma ’ cisplatin u 5- fluorouracil (mediċini oħra kontra l- kanċer). • kanċer fir- ras u fl- għonq f’ pazjenti li jkollhom kanċer avvanzat.
It is used with cisplatin and 5-fluorouracil.
Jista ’ jintuża ma ’ cisplatin u 5 - fluorouracil.
See the Summary of Product Characteristics, also part of the EPAR, for full details.
Ara s- Sommarju tal- Karatteristiċi tal- Prodott, ukoll parti mill- EPAR, għad- dettalji sħaħ.
How is TAXOTERE used?
Kif jintuża TAXOTERE?
TAXOTERE should be used in specialised chemotherapy wards and it should only be given under the supervision of a doctor who is qualified in the use of anticancer chemotherapy.
TAXOTERE għandu jintuża fi swali tal- kemoterapija speċjalizzati u għandu jingħata biss taħt is - sorveljanza ta ’ tabib li jkun kwalifikat fl- użu tal- kemoterapija kontra l- kanċer.
TAXOTERE is only used when the neutrophil count (a type of white blood cell) is at least 1,500 cells/ mm3.
TAXOTERE jintuża biss meta n- numru ta ’ neutrophil (tip ta ’ ċelloli bojod fid- demm) ikun minn ta ’ l- inqas 1, 500 ċellola/ mm3.
Treatment with dexamethasone (an anti-inflammatory medicine) should be given to the patient on the day before treatment for prostate cancer or the day before and the two days after treatment for other types of cancer.
It- trattament b’ dexamethasone (mediċina antinfjammatorja) għandu jingħata lill - pazjent fil- ġurnata ta ’ qabel it- trattament għall- kanċer tal- prostata jew fil- ġurnata ta ’ qabel jew il - jumejn ta ’ wara t- trattament għal tipi ta ’ kanċer oħrajn.
TAXOTERE is given as a one-hour infusion every three weeks.
TAXOTERE jingħata bħala infużjoni ta ’ siegħa kull tliet ġimgħat.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How does TAXOTERE work?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif jaħdem TAXOTERE?
The active substance in TAXOTERE, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Is- sustanza attiva f’ TAXOTERE, docetaxel tagħmel parti mill- grupp ta ’ mediċini ta ’ kontra l- kanċer magħrufa bħala taxanes.
Docetaxel blocks the ability of cells to destroy the internal ‘ skeleton ’ that allows them to divide and multiply.
Docetaxel jimblokka l- abilità taċ- ċelloli li jeqirdu l - ‘ istruttura ’ interna li mbagħad tippermettilhom li sabiex jiddividu u jimmoltiplikaw ruħhom.
With the skeleton still in place, the cells cannot divide and they eventually die.
Jekk l- istruttura tkun għada sħiħa, iċ- ċelloli ma jkunux jistgħu jiddividu ruħhom u eventwalment imutu.
How has TAXOTERE been studied?
Kif ġie studjat TAXOTERE?
TAXOTERE has been studied in a total of around 3,000 breast cancer patients, around 1,900 lung cancer patients, around 1,000 prostate cancer patients, 445 stomach cancer patients and 897 head and neck cancer patients.
TAXOTERE ġie studjat f’ total ta ’ madwar 3, 000 pazjent morda bil- kanċer tas- sider, madwar 1, 900 pazjent b’ kanċer fil- pulmun, madwar 1, 000 pazjent b’ kanċer fil- prostata, 445 pazjent b’ kanċer fl - istonku u 897 pazjent b’ kanċer fir- ras u l- għonq.
In most of these studies, TAXOTERE was combined with other anticancer treatments and compared with combinations of different treatments or the same treatment without TAXOTERE.
Fil- biċċa l- kbira ta ’ dawn l- istudji, TAXOTERE ingħata flimkien ma ’ trattamenti oħra għal kontra l- kanċer u ġie pparagunat ma ’ taħlita ta ’ trattamenti differenti jew ma ’ l- istess trattament mingħajr TAXOTERE.
The main measures of effectiveness were the response rates (percentage of patients whose cancer responded to treatment), the time taken for the disease to progress and the increase in survival time.
Il- miżura ewlenija ta ’ kemm il- prodott huwa effikaċi kienu r- rati ta ’ rispons (il- perċentwal tal- pazjenti li l- kanċer tagħhom irrisponda għat - trattament), iż- żmien li ħadet il- marda biex tiprogressa u ż- żieda fiż- żmien ta ’ għajxien.
What benefit has TAXOTERE shown during the studies?
X' benefiċċji wera TAXOTERE f' dawn l- istudji?
The addition of TAXOTERE to other anticancer treatments produced significant increases in response rates, disease progression or survival in all five types of cancer (breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer).
It- taħlita ta ’ TAXOTERE ma ’ trattamenti oħra kontra l- kanċer ġabet magħha żidiet importanti fir- rati ta ’ rispons, il- progressjoni tal- marda jew is- sopravivenza fil- ħames tipi ta ’ kanċer (kanċer tas- sider, kanċer tal- pulmun mhux ta ’ għamla ta ’ ċelloli żgħar, kanċer tal- prostata, adenocarcinoma ta ’ l- istonku u kanċer tar- ras u ta ’ l- għonq).
Used on its own in breast cancer, TAXOTERE was at least as effective as, and sometimes more effective than the comparator medicines.
Meta ntuża waħdu fil- kanċer tas- sider, TAXOTERE kien effikaċi daqs, jew xi drabi iktar mill- mediċini li ġie pparagunat magħhom.
It was more effective than best supportive care therapy in lung cancer.
Kien iktar effikaċi mill- aħjar terapija ta ’ kura fil- kanċer tal- pulmun.
What is the risk associated with TAXOTERE?
X’ inhu r- riskju assoċjat ma ’ TAXOTERE?
The most common side effects in patients receiving TAXOTERE (seen in more than 1 patient in 10) are neutropenia (reduced white blood cell counts), anaemia (reduced red blood cell counts), thrombocytopenia (low blood platelet counts), febrile neutropenia (neutropenia with fever), peripheral sensory neuropathy (damage to the nerves causing numbness, tingling and pain in the hands and feet), peripheral motor neuropathy (damage to the nerves causing difficulty co-ordinating movements), dysgeusia (taste disturbances), dyspnoea (shortness of breath), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss), skin reactions, nail disorders, myalgia (muscle pain), anorexia (loss of appetite), infections, fluid retention, asthenia (weakness), pain and hypersensitivity (allergic reactions).
L- iktar effetti sekondarji komuni fil- pazjenti li rċevew TAXOTERE (li dehru f’ iktar minn pazjent 1 minn kull 10) huma n- neutropenia (għadd imnaqqas ta ’ ċelloli tad- demm bojod), anaemia (għadd imnaqqas ta ’ ċelloli tad- demm ħomor), thrombocytopenia (tnaqqis fl- għadd tal- plejtlits tad- demm), febrile neutropenia (newtropenja bid- deni), newropatija sensorjali periferali (ħsara fin- nervituri li tikkawża tgħarix, textix u uġigħ fl- idejn u s- saqajn), newropatija motorjali periferali (ħsara lin - nervituri li ġġib magħha diffikultà fil- koordinazjoni tal- movimenti), dysgeusia (disturbi fit- togħma), dyspnoea (diffikultà fit- teħid tan- nifs), stomatitis (infjamazzjoni fir- rita tal- ħalq), dijarea, nawżeja (tħossok ma tiflaħx), rimettar, alopecia (telf tax- xagħar), reazzjonijiet fil- ġilda, problemi fid- dwiefer, myalgia (uġigħ fil- muskoli), anoressija (telf ta ’ l- aptit), infezzjonijiet, żamma ta ’ fluwidi, astenja (dgħjufija), uġigħ u allerġiji (reazzjonijiet allerġiċi).
These side effects may be more severe when TAXOTERE is used with other anticancer medicines.
Dawn l- effetti sekondarji jistgħu jkunu iktar gravi meta TAXOTERE jintuża ma ’ mediċini oħra kontra l- kanċer.
For the full list of all side effects reported with TAXOTERE, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtata b’ TAXOTERE, ara l- Fuljett ta ’ Tagħrif.
TAXOTERE should not be used in people who may be hypersensitive (allergic) to docetaxel or any of the other ingredients.
TAXOTERE m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal docetaxel jew għal xi sustanza oħra tiegħu.
TAXOTERE should not be used in patients who have a neutrophil count of less than 1,500 cells/ mm3, in pregnant or breast-feeding women, or in patients who have severe liver disease.
TAXOTERE m’ għandux jintuża f’ pazjenti li għandhom numru ta ’ neutrophil li huwa inqas minn 1, 500 ċellola/ mm3, f’ nisa tqal jew li qed ireddgħu, u f’ pazjenti li għandhom marda gravi tal- fwied.
Why has TAXOTERE been approved?
Għaliex ġie approvat TAXOTERE?
The Committee for Medicinal Products for Human Use (CHMP) decided that TAXOTERE’ s benefits are greater than its risks for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and squamous cell head and neck cancer.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ TAXOTERE jisbqu r- riskji tiegħu għat- trattament ta ’ kanċer tas- sider, kanċer tal- pulmun mhux ta ’ l - għamla ta ’ ċelluli żgħar, kanċer tal- prostata, adenocarcinoma ta ’ l- istonku u kanċer fir- ras u fl- għonq b’ ċelloli skwamużi.
The Committee recommended that TAXOTERE be given marketing authorisation.
Il- Kumitat irrakomanda li TAXOTERE jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
TAXOTERE was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
TAXOTERE oriġinarjament kien awtorizzat taħt "Ċirkustanzi ta 'Eċċezzjoni", għax, għal raġunijiet xjentifiċi, kien hemm biss tagħrif limitat disponibbli fi żmien l- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 7 July 1998.
Billi l- kumpannija pprovvdiet it- tagħrif addizzjonali mitlub, iċ - "Ċirkustanzi ta 'Eċċezzjoni" intemmu fis- 7 ta' Lulju 1998.
Other information about TAXOTERE:
Tagħrif ieħor dwar TAXOTERE:
The European Commission granted a marketing authorisation valid throughout the European Union for TAXOTERE to Aventis Pharma S. A. on 27 November 1995.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal TAXOTERE lill- Aventis Pharma S. Afis- 27 ta ’ Novembru 1995.
The marketing authorisation was renewed on 27 November 2000 and 27 November 2005.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fis- 27 ta ’ Novembru 2005.
The full EPAR for TAXOTERE is available here.
L- EPAR sħiħ għal TAXOTEREjinstab. hawnhekk
This summary was last updated in 11-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' 11- 2007.
EU Numbers
1/ 2 Numru ta ’ l- EU
Pharmaceutical form
Daqs tal - pakkett
Route of administration Packaging
Konċentrat: kunjett
Content
0. 5ml
Package size
1 kunjett + 1
Concentrate and solvent
Konċentrat u solvent għal soluzzjoni għall- infużjoni.
Concentrate:0.5ml 1
Użu għal ġol- vini
vial + 1 vial
(ħġieġ) Solvent: kunjett (ħġieġ)
for solution for infusion
1. 5 ml
Solvent: vial (glass)
kunjett
Solvent:
Konċentrat:
1.5 ml
2 ml
Concentrate and solvent Intravenous use for solution for infusion
Konċentrat u solvent għal soluzzjoni għall- infużjoni.
Concentrate: vial (glass) Solvent: vial (glass)
Konċentrat: kunjett (ħġieġ) Solvent: kunjett (ħġieġ)
2 ml Solvent:
Solvent:
1 vial + 1 vial
kunjett
London, 20 November 2008 Doc.
Londra, 20 ta ’ Novembru 2008 Dok.
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Taxotere/ Docetaxel Winthrop
Mistoqsijiet u Tweġibiet dwar l- irtirar tal- applikazzjoni għal modifika fl - awtorizzazzjoni għat- tqegħid fis- suq għal Taxotere/ Docetaxel Winthrop
International non-proprietary name (INN): docetaxel
Denominazzjoni Komuni Internazzjonali (DKI): docetaxel