qanastek/EMEA-V3 huggingface dataset:
Common side effects These may affect up to 1 in 10 people: • Feeling sick or being sick (nausea or vomiting), pain in the stomach, loose stools • Skin rashes (red, raised or itchy) – if the skin rash is severe, you may have to stop taking this medicine • Headache, feeling dizzy • Feeling tired • Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called lipase.
Effetti sekondarji komuni Dawn jistgħu jaffettwaw sa 1 f’ 10 minn nies: • Tħossok imqalla jew tkun imqalla (dardir jew remettar), uġigħ fl- istonku, purgar artab • Raxx fil- ġilda (aħmar, imqabbes jew bil- ħakk) – jista ’ jkun li jkollok tieqaf tieħu din il - mediċina jekk ir- raxx fil- ġilda ikun qawwi • Uġigħ ta ’ ras, sturdament • Għeja • Żieda fil- livelli ta ’ enżimi tal- fwied magħrufa bħala transaminases u żieda fil- livelli ta ’ enżima tal- pankreas magħruf bħala lipase. • Tingiż jew tnemnim madwar ix- xufftejn u l- ħalq
Rare side effects These may affect up to 1 in 1000 people: • A severe or life-threatening skin reaction (Stevens Johnson syndrome).
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa 1 f’ 1000 minn nies
If you get any symptoms of infection or signs of inflammation while you’ re taking Telzir: → Tell your doctor immediately.
Jekk ikollok xi sintomi ta ’ infezzjoni jew sinjali ta ’ infjammazzjoni waqt li tkun qed tieħu Telzir: →Għid lit- tabib tiegħek immedjatament.
Your body shape may change People taking combination therapy may find that their body shape changes, because of changes in fat distribution: • Fat may be lost from the legs, arms or face • Extra fat may build up around the tummy (abdomen) or the breasts or internal organs • Fatty lumps (sometimes called a buffalo hump) may appear on the back of the neck.
Tista ’ tinbidel is- sura ta 'ġismek Nies fuq terapija kombinata jistgħu isibu li is- sura ta ’ ġisimhom tinbidel, minħabba bdil fit- tqassim tax- xaħam: • Jista ’ jintilef xaħam mir- riġlejn, dirgħajn u l- wiċċ • Jista ’ ikun hemm żieda ta ’ xaħam madwar iż- żaqq (addomenu) jew is- sider jew organi interni • Għoqod ta ’ xaħam (li kultant jissejħu buffalo hump) jistgħu joħorġu fuq wara ta ’ l- għonq.
It is not yet known what causes these changes, or whether they have any long-term effects on your health.
Għad mhuwiex magħruf x’ jikkawża dawn il- bidliet, jew jekk għandhomx effetti fit- tul fuq saħħtek.
74 People may be more likely to get this condition: • if they have been taking combination therapy for a long time • if they are also taking anti-inflammatory medicines called corticosteroids • if they drink alcohol • if their immune systems are very weak • if they are overweight.
In- nies jista ’ jkollhom aktar possibilita ’ li jkollhom din il- kondizzjoni: • jekk ikunu ilhom jieħdu terapija kombinata għal tul ta ’ żmien • jekk ikunu qegħdin jieħdu wkoll mediċini kontra l- infjammazzjoni li jissejħu kortikosterojdi • jekk jixorbu alkoħol • jekk is- sistemi immunitarji tagħhom ikunu dgħajfa • jekk ikollhom piż żejjed
Signs to look out for include: • stiffness in the joints • aches and pains (especially in the hip, knee or shoulder) • difficulty moving.
• egħbusija fil- ġogi • uġigħ (speċjalment fil- ġog tal- koxxa, fl- irkoppa jew fl- ispalla) • diffikulta ’ biex tiċċaqlaq
Tell your doctor.
Jekk tinnota xi wieħed minn dawn is- sintomi: →Għid lit- tabib tiegħek
Do not freeze.
Tiffriżaħx.
Telzir does not require any other special storage conditions.
Telzir m’ għandux bżonn kundizzjonijiet speċjali oħra għall- ħażna.
Don’ t use Telzir after the expiry date shown on the bottle and the carton.
Tużax Telzir wara d- data ta ’ skadenza li tidher fuq il- flixkun jew il- kartuna.
Throw away the bottle 28 days after first opening it, but don’ t dispose of medicine in your waste water or your household waste.
Armi l- flixkun wara 28 ġurnata li tkun ftaħtu l- ewwel darba, iżda tarmihx ma ’ l- ilma tad - dranaġġ jew ma ’ l- iskart domestiku.
Take it back to your pharmacist who will dispose of it in a way that won’ t harm the environment.
Ħudu lura lill- ispiżjar tiegħek biex jarmih b’ mod li ma jagħmilx ħsara lil- ambjent.
• The active substance is fosamprenavir.
Is- sustanza attiva hi fosamprenavir.
Each ml of suspension contains 50 mg of fosamprenavir as fosamprenavir calcium salt (equivalent to approximately 43 mg of amprenavir).
Kull ml tas- sospensjoni fih 50 mg fosamprenavir bħala fosamprenavir calcium (ekwivalenti għal madwar 43 mg amprenavir).
• The other ingredients are: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate, artificial grape bubblegum flavour, natural peppermint flavour, purified water, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).
Is- sustanzi l- oħra huma: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate, togħma artifiċjali ta ’ għeneb bubblegum, togħma ta ’ peppermint naturali, ilma purifikat, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)
What Telzir looks like and contents of the pack
Id- dehra ta ’ Telzir u l- konenuti tal- pakkett
Telzir is supplied in plastic bottles containing 225 mloral suspension.
Telzir jinbiegħ fi flixken tal- plastik li fihom 225 ml ta ’ soluzzjoni orali.
A 10 ml graduated dosing syringe and an adapter are also included in the pack.
Siringa ta ’ l- 10 ml immarkata għad- dożaġġ u adapter ikunu wkoll fil- kartuna.
The suspension is white to off-white.
Is- sospensjoni hi ta ’ kulur bejn abjad u kważi abjad.
Telzir is also available as 700 mg film-coated tablets.
Telzir jinbiegħ ukoll f’ għamla ta ’ pilloli ta ’ 700mg miksijin b’ rita
75 Marketing Authorisation Holder and Manufacturer
76 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manufattur
Marketing Authorisation Holder
Id- detentur ta ’ l- awtorizzazzjoni għat - tqegħid fis- suq
Industriestrasse 32-36 D-23843 Bad Oldesloe Germany
KG Industriestrasse 32 - 36 D- 23843 Bad Oldesloe Germany
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq.
România GlaxoSmithKline (GSK) S. R. L.
77 România France GlaxoSmithKline (GSK) S. R. L.
What is Temodal?
X' inhu Temodal?
Temodal is a medicine that contains the active substance temozolomide.
Temodal hu mediċina li jkun fiha s- sustanza attiva temozolomide.
It is available as capsules (white and green:
Dan jiġi f’ kapsuli (bojod u ħodor:
5 mg; white and yellow:
5 mg; bojod u sofor:
20 mg; white and pink:
20 mg; bojod u roża:
100 mg; white and blue:
100 mg; bojod u blù:
140 mg; white and orange:
140 mg; bojod u oranġjo:
180 mg; white:
180 mg; bojod:
250 mg) and as a powder to be made up into a solution for infusion (drip into a vein).
250 mg) u bħala trab biex jinħall f’ taħlita likwida għall- infużjoni (drip fil- vina).
What is Temodal used for?
Għal xiex jintuża Temodal?
Temodal is an anticancer medicine.
Temodal huwa mediċina għal kontra l- kanċer.
It is used to treat malignant glioma (brain tumours) in the following groups of patients: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour).
Jintuża biex ifejjaq il- glijoma malijna (tumuri fil- moħħ) fil- gruppi ta ’ pazjenti li ġejjin: • adulti li ġew dijanjostikati għall- ewwel darba bi glijoblastoma multiforme (tip aggressiv ta ’ tumur tal- moħħ).
Temodal is used first with radiotherapy and then on its own; • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Temodal jintuża l- ewwel flimkien mar- radjuterapija mbagħad waħdu; • adulti u tfal minn tliet snin ’ il fuq li jbatu minn glijoma malinja bħalma huma l- glijoblastoma multiforme jew l- astroċitoma anaplastika, meta t- tumur jerġa ’ jitfaċċa jew isir agħar wara l- kura standard.
Temodal is used on its own in these patients.
F’ dawn il- pazjenti Temodal jintuża waħdu.
How is Temodal used?
Kif jintuża Temodal?
Treatment with Temodal should be prescribed by a doctor with experience in the treatment of brain tumours.
It- trattament b' Temodal għandu jiġi preskritt minn tabib li jkollu esperjenza fit- trattament ta 'tumuri tal- moħħ.
The dose of Temodal depends on body surface area (calculated using the patient ’ s height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Id- doża tat- Temodal tiddependi mis- superfiċje tal- ġisem (ikkalkolati mit- tul u l- piż tal- pazjent) u tvarja minn 75 sa 200 mg għal kull metru kwadru, darba kuljum.
The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temodal is being used alone or with other treatments, and how the patient responds to treatment.
Id- doża u n- numru ta ’ dożi jiddependu mit- tip ta ’ tumur li jkun qed jiġi kkurat, skont jekk il- pazjent ikunx diġa ngħata l- kura qabel, skont jekk Temodal ikunx qed jintuża waħdu jew ma ’ trattatmenti oħra, u kif il- pazjent jirrispondi għall- kura.
Temodal capsules should be taken without food.
Il- kapsuli tat- Temodal ma għandhomx jittieħdu mal- ikel.
If the solution for infusion is used, it should be given over a period of 90 minutes.
Jekk tintuża t- taħlita għall- infużjoni, din għandha tieħu 90 minuta biex tingħata.
Patients may also need to take medicines to prevent vomiting before taking Temodal.
Qabel jieħdu Temodal, hemm il- possibiltà li l- pazjenti jkunu jeħtieġu l- mediċini biex jipprevjenu r - rimettar.
Temodal should be used with caution in patients with severe liver problems or with kidney problems.
Temodal għandu jintuża bil- galbu f’ pazjenti bi problemi serji fil- fwied jew bi problemi fil - kliewi.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Għal iżjed dettalji, ara s- Sommarju tal- Karatteristiċi tal- Prodott (parti wkoll mill- EPAR).
How does Temodal work?
Kif jaħdem Temodal?
The active substance in Temodal, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Is- sustanza attiva f’ Temodal, temozolomide, tappartjeni għal grupp ta ’ mediċini ta ’ kontra l- kanċer li jissejħu alkylating agents.
In the body, temozolomide is converted to another compound called MTIC.
Fil- ġisem, temozolomide jinbidel f’ kompożizzjoni oħra msejħa MTIC.
Reproduction is authorised provided the source is acknowledged. binds to the DNA of cells while they are reproducing, which stops cell division.
MTIC jeħel maċ- ċelloli tad- DNA waqt li dawn ikunu qed jirriproduċu, u jwaqqaf il- qsim taċ- ċelloli.
As a result, the cancer cells cannot divide, slowing down the growth of tumours.
B’ riżultat ta ’ dan, iċ- ċelloli tal- kanċer ma jkunux jistgħu jinqasmu, u jnaqqas ir- rimu tat- tkabbir tat - tumuri.
How has Temodal been studied?
Kif ġie studjat Temodal?
Temodal capsules have been studied in four main studies.
Il- kapsuli ta ’ Temodal ġew studjati f’ erba ’ studju ewlenin.
The first study compared the effectiveness of Temodal and radiotherapy with that of radiotherapy on its own in 573 patients with newly diagnosed glioblastoma multiforme.
L- ewwel studju qabbel l- effikaċja ta ’ Temodal u r- radjuterapija mar- radjuterapija waħedha f’ 573 pazjent li ġew dijanjostikati għall- ewwel darba bi glioblastoma multiforme.
The other three main studies involved patients with malignant glioma that had come back or got worse after previous treatment.
It- tliet studji ewlenin l- oħra involvew pazjenti bi glijoma malinja li reġgħet feġġet jew li saret agħar wara l- kura li kienu diġà ħadu.
Two of these studies involved patients with glioblastoma multiforme: one looked at the effects of Temodal in 138 patients and the other compared Temodal with procarbazine (another anticancer medicine) in 225 patients.
Studju minnhom iffoka fuq l- effetti ta ’ Temodal f’ 138 pazjent u l- ieħor qabbel Temodal ma ’ procarbazine (mediċina oħra ta ’ kontra l- kanċer) f’ 225 pazjent.
The final study looked at the safety and effectiveness of Temodal in the treatment of 162 patients with anaplastic astrocytoma who were in their first relapse.
L- istudju finali ta ħarsa lejn l - effikaċja u s- sigurtà ta ’ Temodal fit- trattament ta ’ 162 pazjent b’ astroċitoma anaplastika li kienu qed jirkadu għall- ewwel darba.
The main measures of effectiveness were how long the patients survived or the length of time before the patient ’ s cancer started to get worse.
Il- kejl ewlieni tal- effikaċja kien kemm ser jgħixu l- pazjenti jew kemm ser ikun it- tul ta ’ żmien qabel il- kanċer tal- pazjent jaqleb għall- agħar.
A further two studies were carried out in a total of 35 patients with brain tumours to show that the capsules and solution for infusion produce the same levels of temozolomide in the blood.
Total ta ’ 35 pazjent b’ tumuri fil- moħħ ħadu sehem f’ żewġ studji oħra sabiex jintwera li l- kapsuli u t - taħlita għall- infużjoni jipproduċu l- istess livelli ta ’ temozolomide fid- demm.
What benefit has Temodal shown during the studies?
Liema benefiċċju wera Temodal waqt l- istudji?
In the study of newly diagnosed glioblastoma multiforme, patients survived for an average of 14.6 months when they received Temodal and radiotherapy, compared with 12.1 months with radiotherapy alone.
Fl- istudju ta ’ dawk li ġew dijanjostikati għall- ewwel darba bi glijoblastoma multiforme, il- pazjenti għexu medja ta ’ 14. 6 xhur meta rċevew Temodal u r- radjuterapija, meta mqabbla mat- 12. 1 xhur bir - radjuterapija waħedha.
In the comparative study of glioblastoma multiforme that had come back or got worse after previous treatment, it took an average of 2.9 months until the cancer got worse in patients taking Temodal, compared with 1.9 months in the patients taking procarbazine.
Fl- istudju komparattiv fejn il- glijoblastoma multiforme reġgħet feġġet jew li saret agħar wara l- kura li kienu diġà ħadu, għaddew medja ta ’ 2. 9 xhur sakemm il- kanċer iggrava f’ pazjenti li kienu qed jieħdu Temodal meta mqabbel mal- 1. 9 xhur fil- pazjenti li kienu qed jieħdu l- procarbazine.
In anaplastic astrocytoma, it took an average of 5.4 months for the cancer to get worse in patients taking Temodal.
Fl- astroċitoma anaplastika, għaddew medja ta ’ 5. 4 xhur biex il- kanċer iggrava f’ pazjenti li kienu qed jieħdu Temodal.
What is the risk associated with Temodal?
X’ inhu r- riskju assoċjat ma ’ Temodal?
The most common side effects with Temodal (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, constipation, anorexia (loss of appetite), alopecia (hair loss), headache, fatigue (tiredness), convulsions (fits), rash, neutropenia or lymphopenia (low white blood cell counts), and thrombocytopenia (low blood platelet counts).
L- iżjed effetti sekondarji komuni b’ Temodal (li dehru f’ aktar minn pazjent wieħed minn kull għaxra) huma nawżea (dardir), remettar, stitikezza, anoressija (nuqqas ta ’ aptit), alopeċja (waqgħa tax- xagħar), uġigħ ta ’ ras, għeja, konvulżjonijiet (attakki ta ’ konvulżjoni), raxx, newtropenija jew linfopenija (ċelloli tad- demm bojod f’ numri baxxi), u tromboċitopenija (numri baxxi ta ’ platelet fid- demm).
Patients receiving the solution for infusion may also have injection site reactions, such as pain, irritation, itching, warmth, swelling and redness, as well as bruising.
Il - pazjenti li jingħataw it- taħlita għall- infużjoni jista ’ jkollhom ukoll reazzjonijiet fil- parti fejn jittaqbu, bħalma huma wġigħ, irritazzjoni, ħakk, sħana, nefħa u ħmura, kif ukoll tbenġil.
For the full list of all side effects reported with Temodal, see the Package Leaflet.
Għal- lista sħiħa tal - effetti sekondarji rrappurtati b' Temodal, ara l- Fuljett ta 'Tagħrif.
Temodal should not be used in people who may be hypersensitive (allergic) to temozolomide, any of the other ingredients or dacarbazine (another anticancer medicine).
Temodal ma għandux jintuża f’ persuni ipersensittivi (allerġiċi) għal temozolomide, jew għal xi ingredjenti oħra tiegħu jew għad- dacarbazine (mediċina oħra ta ’ kontra l- kanċer).
Temodal must not be used in patients with severe myelosuppression (a condition in which the bone marrow cannot make enough blood cells).
Temodal ma għandux jintuża f’ pazjenti b’ mjelosuppressjoni severa (kondizzjoni fejn il- mudullun ma jkunx qed jipprdouċi biżżejjed ċelloli fid- demm).
Why has Temodal been approved?
Għaliex ġie approvat Temodal?
The Committee for Medicinal Products for Human Use (CHMP) decided that Temodal’ s benefits are greater than its risks for treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment, and malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Temodal huma akbar mir- riskji għat- trattament ta ’ pazjenti li jkunu ġew dijanjostikati għall- ewwel darba bi glijoblastoma multiforme flimkien mar- radjuterapija u aktar tard bħala trattatment b’ monoterapija, u l- glijoma malinja, bħalma huma l- glijoblastoma multiforme jew l- astroċitoma anaplastika, meta jintwera li l- marda terġa ’ tfeġġ jew taqleb għall- agħar wara t- terapija standard.
The Committee recommended that Temodal be given marketing authorisation.
Il- Kumitat irrakkomanda li Temodal jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Temodal:
Tagħrif ieħor dwar Temodal:
The European Commission granted a marketing authorisation valid throughout the European Union for Temodal to SP Europe on 26 January 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea, għal Temodal lil SP Europe fis- 26 ta ’ Jannar 1999.
The marketing authorisation was renewed on 26 January 2004 and on 26 January 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 26 ta ’ Jannar 2004 u fis- 26 ta ’ Jannar 2009.
The full EPAR for Temodal is available here.
L- EPAR sħiħ għal Temodal jista ’ jiġi kkonsultat hawn.
EU Number EU/ 1/ 98/ 096/ 001 EU/ 1/ 98/ 096/ 002 EU/ 1/ 98/ 096/ 003 EU/ 1/ 98/ 096/ 004 EU/ 1/ 98/ 096/ 005 EU/ 1/ 98/ 096/ 006 EU/ 1/ 98/ 096/ 007 EU/ 1/ 98/ 096/ 008 EU/ 1/ 98/ 096/ 009 EU/ 1/ 98/ 096/ 010 EU/ 1/ 98/ 096/ 011 EU/ 1/ 98/ 096/ 012 EU/ 1/ 98/ 096/ 013 EU/ 1/ 98/ 096/ 014 EU/ 1/ 98/ 096/ 015 EU/ 1/ 98/ 096/ 016 EU/ 1/ 98/ 096/ 017 EU/ 1/ 98/ 096/ 018 EU/ 1/ 98/ 096/ 019 EU/ 1/ 98/ 096/ 020 EU/ 1/ 98/ 096/ 021 EU/ 1/ 98/ 096/ 022 EU/ 1/ 98/ 096/ 023
EU/ 1/ 98/ 096/ 002 EU/ 1/ 98/ 096/ 003 EU/ 1/ 98/ 096/ 004 EU/ 1/ 98/ 096/ 005 EU/ 1/ 98/ 096/ 006 EU/ 1/ 98/ 096/ 007 EU/ 1/ 98/ 096/ 008 EU/ 1/ 98/ 096/ 009 EU/ 1/ 98/ 096/ 010 EU/ 1/ 98/ 096/ 011 EU/ 1/ 98/ 096/ 012 EU/ 1/ 98/ 096/ 013 EU/ 1/ 98/ 096/ 014 EU/ 1/ 98/ 096/ 015 EU/ 1/ 98/ 096/ 016 EU/ 1/ 98/ 096/ 017 EU/ 1/ 98/ 096/ 018 EU/ 1/ 98/ 096/ 019 EU/ 1/ 98/ 096/ 020 EU/ 1/ 98/ 096/ 021 EU/ 1/ 98/ 096/ 022
Invented name Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal
Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal Temodal
Strength 5 mg 5 mg 20 mg 20 mg 100 mg 100 mg 250 mg 250 mg 140 mg 140 mg 180 mg 180 mg 20 mg 20 mg 100 mg 100 mg 140 mg 140 mg 180 mg 180 mg 250 mg 250 mg 2.5 mg/ ml
5 mg 20 mg 20 mg 100 mg 100 mg 250 mg 250 mg 140 mg 140 mg 180 mg 180 mg 20 mg 20 mg 100 mg 100 mg 140 mg 140 mg 180 mg 180 mg 250 mg 250 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Powder for solution for infusion
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa 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 Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Intravenous Use
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Packaging bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) sachet (PET/ alu/ PET) vial (glass)
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Package size 5 20 5 20 5 20 5 20 5 20 5 20 5 capsules 20 capsules 5 capsules 20 capsules 5 capsules 20 capsules 5 capsules 20 capsules 5 capsules 20 capsules
20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula 5 kapsuli 20 kapsula
Temodal 5 mg hard capsules
Kapsuli iebsin Temodal 5 mg
Each hard capsule contains 5 mg temozolomide.
Kull kapsula iebsa fiha 5 mg ta ’ temozolomide.
Each hard capsule contains 132.8 mg of anhydrous lactose.
Kull kapsla iebsa fiha 132. 8 mg anhydrous lactose.
Hard capsule.
Kapsula iebsa
The hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.
Il- kapsuli iebsin għandhom naħa bajda opaka, b’ għatu opak aħdar, u ttimbrati b’ inka sewda.
The cap is imprinted with “ Temodal”.
L- għatu ttimbrat b ’ ” Temodal ”.
The body is imprinted with "5 mg", the Schering-Plough logo and two stripes.
In- naħa l- oħra ttimbrata b ’ ” 5 mg ”, il- logo ta ’ Schering- Plough u żewġ strippi.
Temodal hard capsules is indicated for the treatment of:
Temodal kapsuli iebsin huma indikati għal- kura ta ’ pazjenti b ’:
- adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy
- pazjenti adulti b’ glioblastoma multiforme li tkun għada kemm ġiet dijanjostikata flimkien ma ’
(RT) and subsequently as monotherapy treatment.
radjuterapija (RT) u wara bħala kura b’ monoterapija
- children from the age of three years, adolescents and adult patients with malignant glioma, such
- tfal li jkollhom minn tlett snin ‘ l fuq, adolexxenti, u pazjenti adulti bi glijoma malinna, bħal
as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
glioblastoma multiforme jew astroċitoma anaplastika, li jerġgħu jirkadu jew ikollhom avvanz tal - marda wara li tkun ingħatat terapija standard.
Temodal hard capsules should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Temodal kapsuli iebsin għandhom jinkitbu biss minn tobba b’ esperjenza fil- kura onkoloġika ta ’ tumuri tal- moħħ.
Anti-emetic therapy may be administered (see section 4.4).
Kura anti- emetika tista ’ tingħata (ara sezzjoni 4. 4).
Adult patients with newly-diagnosed glioblastoma multiforme
Pazjenti adulti li jkunu għadhom kif ġew dijanjostikati b’ glioblastoma multiforme
Temodal hard capsules is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Temodal kapsuli iebsin jingħataw kumbinati ma ’ radjuterapija fokali (fażi konkomitanti) segwit b’ mhux aktar minn 6 ċikli b’ monoterapiji ta ’ temozolomide (TMZ) (fażi ta ’ monoterapija).
Concomitant phase TMZ is administered orally at a dose of 75 mg/ m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
TMZ jingħata b’ mod orali b’ doża ta ’ 75 mg/ m2 kuljum għal 42 jum flimkien ma ’ radjuterapija fokali (60 GY mogħtija fi 30 frazzjonijiet).
No dose reductionsare recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria.
Mhux rakkomandat li jitnaqsu d- dożi, iżda l- għotja ta ’ TMZ għandha tkun rimandata jew imwaqqfa fuq deċiżjoni li tittieħed kull ġimgħa skond kriterji ta ’ tossiċità ħematoloġika u dik mhux ħematoloġika.
TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
L- għotja ta ’ TMZ tista ’ titkompla fil- perijodu ta ’ 42 jum meta jkunu qed jingħataw flimkien (sa 49 jum) jekk il- kundizzjonijiet kollha li ġejjin ikunu jgħoddu: għadd assolut tan- newtrofili (ANC) ≥ 1. 5 x 109/ l
- thrombocyte count ≥ 100 x 109/ l
għadd tat- tromboċiti ≥ 100 x 109/ l
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea
- kriterji tossiċi komuni (CTC), tossiċità ħematoloġika ≤ Grad 1 (ħlief għal alopeċja, tqallih u
and vomiting).
rimettar).
During treatment a complete blood count should be obtained weekly.
Waqt il- kura, l- għadd komplet tad- demm għandu jinkiseb kull ġimgħa.
TMZ administration should be temporarily interrupted or permanently discontinued during the concomitant phase according to the haematological and non-haematological toxicity criteria as noted in Table 1.
L- għotja ta ’ TMZ għandha titwaqqaf għal xi żmien jew għal kollox waqt il- fażi meta jkunu qed jingħataw flimkien skond il - kriterji ta ’ tossiċità ħematoloġika u mhux ħematoloġika kif jidher f’ Tabella 1.
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
It- twaqqif momentanju jew definit tad- dożi ta ’ TMZ meta jkunu qed jingħataw flimkien ir- radjuterapija u TMZ
Toxicity
Tossiċità
TMZ interruptiona
Twaqqif momentanju ta ’ TMZ a
Absolute neutrophil count
Twaqqif definit ta ’ TMZ < 0. 5 x 109/ l
< 0.5 x 109/ l
≥ 0. 5 u < 1. 5 x 10 / l < 10 x 109/ l
Thrombocyte count CTC non-haematological toxicity
Għadd tat- tromboċiti Tossiċità mhux ħematoloġika CTC (ħlief għal alopeċja, tqallih,
≥ 10 and < 100 x 109/ l
≥ 10 u < 100 x 109/ l
(except for alopecia, nausea, vomiting)
rimettar)
CTC Grade 3 or 4
CTC Grad 3 u 4
Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/ l; thrombocyte count ≥ 100 x 109/ l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Il- kura b’ TMZ mogħti b’ mod konkomitanti tista ’ titkompla meta dawn il- kundizzjonijiet kollha jkunu jgħoddu: għadd assolut tan- newtrofili ≥ 1. 5 x 109/ l; għadd tat- tromboċiti ≥ 100 x 109/ l; tossiċità mhux ħematoloġika CTC ta ’ ≤ Grad 1 (ħlief għal alopeċja, tqallih, rimettar).
Monotherapy phase
Fażi ta ’ Monoterapija
Four weeks after completing the TMZ + RT concomitant phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Erba ’ ġimgħat wara li ntemmet il- fażi konkomitanti ta ’ TMZ + RT, TMZ ikompli jingħata sa ’ 6 ċikli ta ’ kura b’ monoterapija.
Dose in Cycle 1 (monotherapy) is 150 mg/ m2 once daily for 5 days followed by 23 days without treatment.
Id- doża f’ Ċiklu 1 (monoterapija) huwa 150 mg/ m2 darba kuljum għal 5 tijiem segwit b’ 23 jum mingħajr kura.
At the start of Cycle 2, the dose is escalated to 200 mg/ m2 if the CTC non- haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/ l, and the thrombocyte count is ≥ 100 x 109/ l.
Fil- bidu ta ’ Ċiklu 2, id- doża tiżdied għal 200 mg/ m2 jekk it- tossiċità mhux ħematoloġika CTC għal Ċiklu 1 huwa Grad ≤ 2 (ħlief għal alopeċja, tqallih u rimettar), jekk l - għadd assolut tan- newtrofili (ANC) jkun ≥ 1. 5 x 109/ l, u l- għadd tat- tromboċiti jkun ≥ 100 x 109/ l.
If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Jekk id- doża ma tkunx ġiet miżjuda ma ’ Ċiklu 2, m’ għandux ikun hemm żieda fid- doża fiċ- ċikli ta ’ wara.
Once escalated, the dose remains at 200 mg/ m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Ladarba d- doża tkun ġiet miżjuda, tinżamm għal 200 mg/ m2 kuljum fl- ewwel 5 tijiem ta ’ kull ċiklu li jkun imiss ħlief jekk isseħħ tossiċità.
Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.
It- tnaqqis u t- twaqqif tad- dożi waqt il- fażi ta ’ monoterapija għandhom isiru skond f’ Tabelli 2 u 3.
During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ).
Waqt il- kura, l- għadd komplet tad- demm għandu jinkiseb f’ Jum 22 (21 jum wara l- ewwel doża ta ’ TMZ).
The dose should be reduced or administration discontinued according to Table 3.
Id- doża għandha titnaqqas jew l- għotja titwaqqaf skond Tabella 3.
TMZ dose levels for monotherapy treatment
Il- livelli tad- doża ta ’ TMZ għal- kura b’ monoterapija
Dose level
Livell tad- doża
TMZ dose (mg/ m2/ day)
Doża ta ’ TMZ (mg/ m2/ jum)
Remarks
Kummenti
Reduction for prior toxicity Dose during Cycle 1 Dose during Cycles 2-6 in absence of toxicity
Tnaqqis għal tossiċità li kienet seħħet qabel Doża waqt Ċiklu 1 Dożi waqt Ċikli 2- 6 jekk ma jkunx hemm tossiċità
TMZ dose reduction or discontinuation during monotherapy treatment
Tnaqqis jew twaqqif tad- doża ta ’ Temodal waqt kura b’ monoterapija
Reduce TMZ by 1 dose levela
Naqqas TMZ b’ livell ta ’ doża 1a 9
Discontinue TMZ
Waqqaf TMZ
Absolute neutrophil count Thrombocyte count CTC non-haematological Toxicity
Għadd assolut tan- newtrofili
See footnote b See footnote b
Ara n- nota b ta ’ taħt CTC Grad 4b
(except for alopecia, nausea, vomiting) a:
(ħlief għal alopeċja, tqallih, rimettar)
TMZ dose levels are listed in Table 2. b:
Livelli tad- doża ta ’ TMZ huma elenkati f’ Tabella 2.
TMZ is to be discontinued if:
TMZ għandu jitwaqqaf jekk:
dose level -1 (100 mg/m2) still results in unacceptable toxicity the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
L- istess tossiċità mhux ħematoloġika ta ’ Grade 3 (ħlief għal alopeċja, tqallih, rimettar) terġa tiġri wara. tnaqqis fid- doża
3 Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Pazjenti adulti u pedjatriċi minn 3 snin ‘ l fuq bi glijoma malinna rikurrenti jew progressiva:
A treatment cycle comprises 28 days.
Ċiklu ta ’ trattament jikkonsisti f’ 28 jum.
In patients previously un treated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
F’ pazjenti li qabel ma kinux ikkurati bil- kimoterapija, TMZ jittieħed mill- ħalq f’ doża ta ’ 200 mg/ m2 darba kuljum għall- ewwel 5 tijiem, segwiti minn 23 jum ta ’ waqfien mil- kura (total ta ’ 28 jum).
In patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily, to be increased in the second cycle to 200 mg/m2 once daily, for 5 days if there is no haematological toxicity (see section 4.4)
F’ pazjenti li qabel kienu kkurati bil- kimoterapija, id- doża tal- bidu hija 150 mg/ m2 darba kuljum, li tkun miżjuda fit- tieni ċiklu għal 200 mg/ m2 kuljum, għal 5 tijiem jekk ma jkunx hemm tossiċità ħematoloġika (ara sezzjoni 4. 4).
In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Pazjenti pedjatriċi F’ pazjenti ta ’ 3 snin jew akbar, TMZ jintuża biss f’ każ ta ’ glijoma malinna rikurrenti jew progressiva.
There is no clinical experience with use of TMZ in children under the age of 3 years.
M’ hemmx esperjenza klinika bl- użu ta ’ TMZ fi tfal taħt it- 3 snin.
Experience in older children is very limited (see sections 4.4 and 5.1).
L- esperjenza fi tfal akbar hija limitata ħafna (ara sezzjonijiet 4. 4 u 5. 1).
The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepaticimpairment.
Pazjenti b’ indeboliment epatiku jew renali Il- farmakokinetika ta ’ TMZ kienet kumparabbli f' pazjenti b’ funzjoni epatika normali u f’ dawk b’ indeboliment epatiku ħafif jew moderat.
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child’s Class C) or with renalimpairment.
M’ hemmx informazzjoni disponibbli dwar l- għoti ta ’ TMZ f’ pazjenti b’ indeboliment epatiku serju (Child’ s Class C) jew b’ indeboliment renali.
Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renalimpairment.
Ibbażat fuq il - karatteristiċi farmakokinetika ta ’ TMZ, tnaqqis fid- doża x’ aktarx li ma jkunx meħtieġ f’ pazjenti b’ indeboliment epatiku serju jew kwalunkwe grad ta ’ indeboliment renali.
However, caution should be exercised when TMZ is administered in these patients.
Madankollu, attenzjoni hi meħtieġa meta TMZ jingħata f’ dawn il- pazjenti.
Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Ibbażat fuq analiżi farmakokinetika tal- popolazzjoni f’ pazjenti ta ’ età bejn 19- 78 sena, it- tneħħija ta ’ TMZ mhijiex affettwata mill- età.
However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Madankollu, jidher li pazjenti anzjani (> 70 sena) għandhom riskju akbar li jkollhom newtropenja u tromboċitopenja (ara sezzjoni 4. 4).
Temodal hard capsules should be administered in the fasting state.
Temodal kapsuli iebsin għandhom jittieħdu meta wieħed ikun sajjem.
The capsules must be swallowed whole with a glass of water and must not be opened or chewed.
Il- kapsuli għandhom jinbelgħu sħaħ ma ’ tazza ilma u m’ għandhomx jiftħuhom jew jomgħoduhom.
If vomiting occurs after the dose is administered, a second dose should not be administered that day.
Jekk ir- rimettar iseħħ wara l- għoti tad- doża, it- tieni doża m’ għandhiex tingħata dakinhar.
Hypersensitivity to the active substanceor to any of the excipients.
4 Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Hypersensitivity to dacarbazine (DTIC).
Sensittività eċċessiva għal dacarbazine (DTIC).
Severe myelosuppression (see section 4.4).
Majelosoppressjoni severa (ara sezzjoni 4. 4).
Pneumocystis carinii pneumonia
Pnewmonja bi Pneumocystis carinii
Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis carinii pneumonia (PCP).
Pazjenti li ngħataw TMZ flimkien ma ’ RT fi prova gwida għall- iskeda mtawla ta ’ 42- jum intwerew li kellhom riskju partikolari li taqbadhom pulmonite b ’ Pneumocystis carinii (PCP).
Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Għalhekk terapija biex tilqa ’ kontra PCP hija meħtieġa għal pazjenti kollha li qed jirċievu TMZ flimkien ma ’ RT għall - kors ta ’ 42- jum (b’ massimu ta ’ 49 jum) ikun x’ ikun l- għadd tal- limfoċiti.
If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to grade ≤ 1.
Jekk isseħħ limfopenja, għandhom jibqgħu għaddejin bit- terapija biex tilqa ’ sakemm jirkupraw mill- limfopenja għal grad ≤ 1.
4 There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Jista ’ jkun hemm aktar każijiet ta’ PCP meta TMZ jingħata għal kors itwal.
However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Madankollu, il- pazjenti kollha li qed jirċievu TMZ, l- aktar dawk li qed jirċievu sterojdi, għandhom jinżammu taħt osservazzjoni mill- qrib għall- PCP, ikun x’ ikun il- kors.
Malignancies
Tumuri
Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Każijiet ta ’ sindrome majelodisplastika u tumuri sekondarji, inkluża lewkimija majelojde kienu irrappurtati b’ mod rari ħafna (ara sezzjoni 4. 8).
Anti-emetic therapy
Terapija kontra t- tqallih
Nausea and vomiting are very commonly associated with TMZ.
Dardir u rimettar iseħħu b’ mod komuni ħafna b’ TMZ.
Anti-emetic therapy may be administered prior to or following administration of TMZ.
Terapija kontra t- tqallih tista ’ tingħata qabel ma jingħata TMZ.
Adult patients with newly-diagnosed glioblastoma multiforme
Pazjenti adulti b’ glioblastoma multiforme li tkun għada kif ġiet dijanjostikata
Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Kura biex tilqa ’ għat- tqallih hija rakkomandata qabel l- ewwel doża tal- fażi konkomitanti u hija rakkomandata ħafna waqt il- fazi b’ monoterapija.
Patients with recurrent or progressive malignant glioma
Pazjenti b’ glijoma malinna rikurrenti jew progressiva
Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Pazjenti li fiċ- ċikli ta ’ kura li ngħataw qabel irrimettew ħafna (Grad 3 jew 4) jista ’ jkollhom bżonn kura kontra t- tqallih.
Laboratory parameters
Parametri tal- laboratorju Qabel id- dożaġġ, dawn il- parametri tal- laboratorji li ġejjin iridu jintlaħqu:
ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
ANC ≥ 1. 5 x 109/ l u għadd tal- plejtlets ≥ 100 x 109/ l.
A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109/l.
Għadd komplet tad- demm għandu jinkiseb fit- 22 Jum (21 jum wara l- ewwel doża) jew sa 48 siegħa minn dak il- jum, u kull ġimgħa sakemm l- ANC ikun > 1. 5 x 109/ l u l- għadd tal - plejtlets ikun > 100 x 109/ l.
If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Jekk l- ANC jaqa ’ għal < 1. 0 x 109/ l jew l- għadd tal- plejtlets ikun < 50 x 109/ l waqt xi ċiklu, iċ- ċiklu li jmiss għandu jitnaqqas b’ livell wieħed ta ’ doża (ara sezzjoni 4. 2).
Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Il- livelli tad- doża jinkludu 100 mg/ m2, 150 mg/ m2, u 200 mg/ m2.
The lowest recommended dose is 100 mg/m2.
L- inqas doża rrikkmandata hija ta ’ 100 mg/ m2.
Paediatric use
Użu pedjatriku
There is no clinical experience with use of TMZ in children under the age of 3 years.
M’ hemmx esperjenza klinika bl- użu ta ’ TMZ fi tfal li għandhom inqas minn 3 snin.
Experience in older children and adolescents is very limited (see sections 4.2 and 5.1).
Esperjenza fi tfal akbar u adolexxenti hija limitata ħafna (ara sezzjonijiet 4. 2 u 5. 1).
Elderly patients (> 70 years of age)
Pazjenti anzjani (> 70 sena)
Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
5 Pazjenti anzjani jidhru li huma f' riskju akbar li jkollhom newtropenja u tromboċitopenja, meta mqabbla ma ’ pazjenti iżgħar.
Therefore, special care should be taken when TMZ is administered in elderly patients.
Għalhekk, attenzjoni speċjali trid tingħata meta TMZ jingħata lill - pazjenti anzjani.
Male patients
Pazjenti rġiel
Men being treated with TMZ should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment (see section 4.6).
Irġiel li qed ikunu ttrattati b’ TMZ huma kunsiljati biex ma jkollhomx tfal sa 6 xhur wara li jkunu irċievew l- aħħar doża u biex jieħdu parir dwar il- krijokonservazzjoni ta ’ l- isperma qabel it- trattament (ara sezzjoni 4. 6).
Lactose
Lattożju
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti li għandhom mard rari ereditarju ta ’ nuqqas ta ’ tolleranza għal galactose, deffiċenza ta ’ Lapp lactase jew malassorbiment ta ’ glukosju- galactose m’ għandhomx jieħdu din il- mediċina.
Interaction studies have only been performed in adults.
Studji ta ’ interazzjoni saru biss f’ adulti.
5 In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
Fi studju separat ta ’ fażi I, l- għotja ta ’ TMZ ma ’ ranitidine ma bidilx il- grad ta ’ assorbiment ta ’ temozolomide jew l- esponiment għal metabolu attiv tiegħu monomethyl triazenoimidazole carboxamide (MTIC).
Administration of TMZ with food resulted in a 33% decrease in Cmax and a 9% decrease in area under the curve (AUC).
L- għoti ta ’ TMZ ma ’ l- ikel irriżulta fi tnaqqis ta ’ 33% ta ’ Cmax u fi tnaqqis ta ’ 9% fl- erja taħt il- kurva (AUC).
As it cannot be excluded that the change in Cmax is clinically significant, Temodal should be administered without food.
Billi ma jistax ikun eskluż li t- tibdil f’ Cmax huwa klinikament sinifikanti, TMZ għandu jittieħed mingħajr ikel.
Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Ibbażat fuq analiżi tal- farmakokinetiċi tal- popolazzjoni minn fi provi ta ’ fażi II, l- għoti flimkien ta ’ dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, antagonisti tar- riċettur ta ’ l- H2, jew phenobarbital ma biddlux it- tneħħija ta ’ TMZ.
Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
L- għoti flimkien ma ’ valproic acid kien assoċjat ma ’ tnaqqis żgħir iżda statistikament rilevanti fit- tneħħija ta ’ TMZ.
No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Ma saru l- ebda studji biex jiddeterminaw l- effett ta ’ TMZ fuq il- metaboliżmu jew l- eliminazzjoni ta ’ prodotti mediċinali oħra.
However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Madankollu, billi TMZ ma jgħaddix minn metaboliżmu tal- fwied u ma tantx jeħel mal- proteini tad- demm, x’ aktarx li ma jaffettwax il- farmakokinetiċi ta ’ prodotti mediċinali oħra (ara sezzjoni 5. 2).
Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
L- użu ta ’ TMZ flimkien ma ’ sustanzi majelosoppressivi oħra, jista ’ jżid il- possibilità ta ’ majelosoppressjoni.
There are no data in pregnant women.
M’ hemmx dejta fuq nisa waqt it- tqala.
In preclinical studies in rats and rabbits receiving 150 mg/m2 TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Fi studji ta ’ qabel l- użu kliniku fuq firien u fniek li kienu qed jirċievu 150 mg/ m2, it- teratoġeniċità u/ jew tossiċità tal- fetu kienu murija (ara sezzjoni 5. 3).
Temodal hard capsules should not be administered to pregnant women.
Temodal kapsuli iebsin m’ għandux jingħata lil nisa waqt it- tqala.
If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Jekk l- użu waqt it- tqala jkun ikkunsidrat, il- pazjenta għandha tkun infurmata dwar ir- riskju potenzjali għall- fetu.
Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Nisa li potenzjalment jista ’ jkollhom it- tfal għandhom jingħataw il- parir biex jużaw metodu ta ’ kontraċezzjoni effettiv biex jevitaw li joħorġu tqal waqt li jkunu qed jirċievu TMZ.
It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
6 Mhux magħruf jekk TMZ joħroġx mal- ħalib tal- mara; għalhekk, it- treddigħ għandu jitwaqqaf waqt il - kura b’ TMZ.
Male fertility
Fertilità tar- raġel
TMZ can have genotoxic effects.
TMZ jista ’ jkollu effetti ġenotossiċi.
Therefore, men being treated with it should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment, because of the possibility of irreversible infertility due to therapy with TMZ.
Għalhekk, irġiel li qed ikunu ttrattati għandhom ikunu kkunsiljati biex ma jkollhomx tfal sa 6 xhur wara l- aħħar doża, u biex jieħdu parir dwar il- krijokonservazzjoni ta ’ l- isperma qabel il- kura minħabba l- possibbiltà ta ’ infertilità irreversibbli minħabba t- terapija b’ TMZ.
The ability to drive and use machines may be impaired in patients treated with TMZ due to fatigue and somnolence.
Il- ħila biex issuq u biex tħaddem magni tista ’ tkun imnaqqsa f’ pazjenti kkurati b’ TMZ minħabba għejja kbira u ngħas.
Clinical trial experience
Esperjenza mill- provi kliniċi
Convulsions were reported very commonly in the newly- diagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very
F’ pazjenti ikkurati b’ TMZ, kemm kombinat ma ’ RT, jew bħala monoterapija wara RT għal glioblastoma multiforme li tkun għada kif ġiet dijanjostikata, jew bħala monoterapija f’ pazjenti b’ glijoma rikurrenti jew progressiva, l- effetti avversi komuni ħafna rappurtati kienu simili: tqallih, rimettar, stitikezza, anoressija, uġigħ ta ’ ras u għejja.
6 commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Aċċessjonijiet kienu rappurtati komuni ħafna f’ pazjenti b’ glioblastoma multiforme li tkun għada kif ġiet dijanjostikata li kienu qed jirċievu monoterapija, u raxx kien rappurtat komuni ħafna f’ pazjenti b’ glioblastoma multiforme li tjun għada kif ġiet dijanjostikata li kienu qed jirċievu TMZ flimkien ma ’ RT kif ukoll bħala monoterapija u komuni b’ glijoma rikurrenti.
Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5);the frequency of grade 3-4 laboratory findings is presented after each table.
Ħafna mir- reazzjonijet avversi ħematoloġiċi kienu rappurtati komuni jew komuni ħafna fiż- żewġ indikazzjonijiet (Tabelli 4 u 5); il- frekwenza ta ’ grad 3- 4 tas- sejbiet tal - laboratorju tidher wara kull tabella.
In the tables undesirable effects are classified according to System Organ Class and frequency.
Fit- tabelli l- effetti mhux mixtieqa huma klassifikati skond is- Sistema tal- Klassi ta ’ l- Organi u l - frekwenza.
Frequency groupings are defined according to the following convention:
Il- gruppi tal- frekwenza huma mqassma skond il- konvenzjoni li jmiss:
Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100).
Komuni ħafna (≥ 1/ 10); Komuni (≥ 1/ 100 to < 1/ 10); Mhux komuni (≥ 1/ 1, 000 to < 1/ 100).
Newly-diagnosed glioblastoma multiforme
Glioblastoma multiforme li tkun għada kif ġiet dijanjostikata
Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Tabella 4 turi effetti avversi li ħarġu mal- kura f’ pazjenti li jkunu għadhom kif ġew dijanjostikati b’ glioblastoma multiforme waqt il- fażijiet ta ’ terapija konkomitanti u monoterapija.
Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme
Kundizzjonijiet li ħarġu mill- kura meta ngħataw flimkien u meta ngħata waħdu f’ pazjenti b’ glioblastoma multiforme li tkun għada kif ġiet dijanjostikata
System Organ Class Infections and infestations
Sistema tal- Ġisem Infezzjonijiet u infestazzjonijiet
concomitant RT n=288*
+ RT flimkien n=288 *