qanastek/EMEA-V3 huggingface dataset:
102 Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Dejta dwar l- effikaċja klinika f’ pazjenti b’ glioblastoma multiforme (Statut tal- prestazzjoni Karnofsky [KPS] ≥ 70), progressiva jew rikurrenti wara operazzjoni jew RT, kienet ibbażata fuq żewġ provi kliniċi b’ TMZ orali.
One was a non-comparative trial in 138 patients (29% received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67% received prior treatment with nitrosourea based chemotherapy).
Waħda kienet prova mhux komparattiva f’ 138 pazjent (29% kienu rċevew il - kimoterapija qabel), u l- oħra kienet prova randomized kontrollata b’ mod attiv ta ’ TMZ vs procarbazine f’ total ta ’ 225 pazjent (67% kienu rċivew trattament qabel bil- kimoterapija bbażata fuq nitrosourea).
In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
Fiż- żewġ provi, il- fini primarju kien is- sopravivenza mingħajr progressjoni (PFS) kif definit minn skans ta ’ MRI jew mis- sistema newroloġika li tmur għall- agħar.
In the non-comparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
Fi prova mhux komparattiva, l- PFS wara 6 xhur kien ta ’ 19%, is- sopravivenza mingħajr progressjoni medjana kienet ta ’ 2. 1 xhur, u l - medjan tas- sopravivenza totali kien ta ’ 5. 4 xhur.
The objective response rate (ORR) based on MRI scans was 8%.
Ir- rata ta ’ rispons oġġettiv (ORR) ibbażata fuq skans ta ’ l- MRI kienet ta ’ 8%.
In the r andomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21% vs 8%, respectively – chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
Fil- prova randomised ikkontrollata b’ mod attiv, il- PFS ma ’ 6 xhur kien akbar b’ mod sinifikanti għal TMZ milli għal procarbazine (21% vs 8%, rispettivament – chi- square p = 0. 008) bil- PFS medjan ta ’ 2. 89 u 1. 88 xhur rispettivament (log rank p = 0. 0063).
Data on time to worsening of neurological status favoured TMZ over procarbazine as did data on time to worsening of performance status (decrease to a KPS of < 70 or a decrease by at least 30 points).
Dejta dwar iż- żmien meta l- istat newroloġiku mar għall- agħar iffavorixxa TMZ fuq procarbazine, kif għamlet id- dejta dwar iż- żmien meta l- istatut ta ’ prestazzjoni mar għall- agħar (tnaqqis għal KPS ta ’ < 70 jew tnaqqis b’ mill- inqas 30 punt).
The median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
Iż- żminijiet medjani għall- progressjoni f’ dawn il- fini varja minn 0. 7 sa 2. 1 xhur aktar għal TMZ milli għal procarbazine (log rank p = < 0. 01 sa 0. 03).
In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
Fi prova multiċentrika, prospettiva ta ’ fażi II li evalwat is- sigurtà u l- effikaċja ta ’ TMZ orali fit - trattament ta ’ pazjenti b’ astroċitoma anaplastika wara l- ewwel rikaduta, wara 6 xhur il- FPS kienet ta ’ 46%.
Median overall survival was 14.6 months.
Ir- rata
Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
103 ta ’ rispons, ibbażata fuq il- valutazzjoni tal- verifikatur ċentrali, kienet ta ’ 35% (13 CR u 43 PR) għall - popolazzjoni intent- to- treat (ITT) n=162.
The 6-month event-free survival for the ITT population was 44% with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Is- sopravivenza mingħajr każijiet wara 6 xhur għall- popolazzjoni ITT kienet ta ’ 44% b’ medjan ta ’ sopravivenza mingħajr kazijiet ta ’ 4. 6 xhur, li kienet tixbah lir- riżultati tas- sopravivenza mingħajr progressjoni.
Achieving a radiological objective response or maintaining progression-free status was strongly associated with maintained or improved quality of life.
Li jintlaħaq rispons oġġettiv radjuloġiku jew li l- istat mingħajr progressjoni jinżamm, kien assoċjat ħafna ma ’ kemm inżammet jew tjiebet il- kwalità tal- ħajja.
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3- methyl(triazen-1-yl)imidazole-4-carboxamide (MTIC).
TMZ jkun idrolizzat b’ mod spontanju fil- pH fiżjoloġiku għall- ispeċi attivi, 3- methyl - (triazen- 1- yl) imidazole- 4- carboxamide (MTIC).
MTIC is spontaneously hydrolyzed to 5amino-imidazole4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
MTIC jkun idrolizzat b’ mod spontanju għal 5- amino- imidazole- 4- carboxamide (AIC), intermedju mgħaruf fil- bijosintesi tal- purini u aċidi nuklejiċi u ta ’ methylhydrazine, li hu maħsub li jkun l- ispeċi attivi alkylating.
In an open-label, two-way crossover bioequivalence study of the pharmacokinetics of oral and intravenous TMZ in patients with primary CNS malignancies, Temodal 2.5 mg/ml powder for solution for infusion administered over 90 minutes was found to be bioequivalent for Cmax and AUC of TMZ and MTIC as compared to Temodal hard capsules, following administration of 150 mg/m2 dose.
Fi studju ta ’ bioekwivalenza two- way crossover, open label dwar il- farmakokinetika ta TMZ orali u dak li jingħata minn ġol- vina f’ pazjenti b’ tumuri ewlenin tas- CNS, Temodal 2. 5 mg/ ml trab għal soluzzjoni għall- infużjoni li ngħata fuq perijodu ta ’ 90 minuta instab li huwa bioekwivalenti għal Cmax u AUC ta ’ TMZ u MTIC meta mqabbel ma ’ Temodal kaspuli iebsin, wara l- għotja ta ’ doża ta ’ 150 mg/ m2.
Mean Cmax values for TMZ and MTIC were 7.4 µg/ml and 320 ng/ml, respectively, following 90 minute intravenous infusion.
Il- medja tal- valuri ta ’ Cmax għal TMZ u MTIC kienu 7. 4 μg/ ml u 320 ng/ ml, rispettivament, wara infużjoni għal ġol- vina ta ’ 90 minuta.
Mean AUC (0 → ∞) values for TMZ and MTIC were 25 µg•h/ml and 1,004 ng•h/ml, respectively.
Il- medja tal- valuri ta ’ l- AUC (0 → ∞) għal TMZ u MTIC kienu 25 µg• h/ ml u 1, 004 ng• h/ ml, rispettivament.
103 Absorption
Assorbiment
PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF.
Studji PET fil- bnedmin u dejta ta ’ qabel l- użu kliniku jindikaw li TMZ jaqsam malajr mill- barriera ta ’ bejn id- demm u l- moħħ u jinstab fis- CSF.
CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30% of that in plasma, which is consistent with animal data.
Il- fatt li jippenetra fis- CSF kien konfermat f’ pazjent wieħed; l- esponiment għal CSF ibbażat fuq l- AUC ta ’ TMZ kien madwar 30% ta ’ dak fil- plażma, li huwa konsistenti mad- dejta mill- annimali.
The half-life (t1/2) in plasma is approximately 1.8 hours.
Il- half life (t1/ 2) fil- plażma hija madwar 1. 8 sigħat.
Following oral administration, approximatively 5% to 10% of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Wara għotja orali, madwar 5% sa 10% tad- doża tiġi rkuprata mhux mibdula mill- awrina fuq 24 siegħa, u l- bqijja eskretat bħala aċidu temozolomide, 5- aminoimidazole- 4- carboxamide (AIC) jew metaboli polari li ma ġewx identifikati.
Plasma concentrations increase in a dose-related manner.
104 Il- konċentrazzjonijiet fil- plażma jiżdiedu b’ manjiera relatata mad- doża.
Plasma clearance, volume of distribution and half-life are independent of dose.
It- tneħħija mill- plażma, volum ta ’ distribuzzjoni u il- half- life jiddependu mid- doża.
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Analiżi tal- farmakokinetika ta ’ TMZ ibbażata fuq il- popolazzjni wriet li t- tneħħija mill- plażma ta ’ TMZ kienet indipendenti mill- età, funzjoni renali jew l- użu tat- tabakk.
In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
Fi studju farmakokinetiku separat, il- profili farmakokinetiċi fil- plażma f’ pazjenti b’ indeboliment epatiku ħafif għal moderat kienu simili għal dawk li dehru f’ pazjenti b’ funzjoni epatika normali.
Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.
Pazjenti pedjatriċi kellhom AUC ogħla minn dak ta’ pazjenti adulti, madankollu, l- ogħla doża tollerata (MTD) kienet 1, 000 mg/ m2 għal kull ċiklu kemm fit- tfal kif ukoll fl- adulti.
Most of the toxicity showed evidence of reversibility, except for adverse events on the male reproductive system and retinal degeneration.
Kien hemm evidenza li l- biċċa l- kbira tat- tossiċità kienet riversibbli, ħlief f’ eventi avversi fis- sistema riproduttiva maskili u fid- deġenerazzjoni tar- retina.
Dose-related reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
It- tnaqqis fil- lewkoċiti u fil- plejtlets relatat mad- doża jidher li huwa indikatur sensittiv tat- tossiċità.
This latency period is very short even for an alkylating agent.
Dan il- perijodu ta ’ latency huwa qasir ħafna, anke għal sustanza alkylating.
104 Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Ir- riżultati ta ’ testijiet ta ’ chromosome aberration ta ’ l- Ames/ salmonella u l- Limfoċit tad- Demm Periferali tal- Bniedem (HPBL) urew rispons pożittiv għall- mutaġeniċità.
The intravenous formulation produced local irritation at the site of injection in both rabbits and rats.
Il- formulazzjoni li tingħata minn ġol- vina ikkawżat irritazzjoni lokali fis- sit mnejn tingħata l - injezzjoni kemm fil- fniek kif ukoll fil- firien.
The irritation was transient and not associated with lasting tissue damage.
L- irritazzjoni kienet mumentanja u ma kienetx assoċjata ma ’ ħsara dejjiema fit- tessuti.
Mannitol (E421) Threonine Polysorbate 80 Sodium citrate (for pH adjustment) Hydrochloric acid concentrated (for pH adjustment)
Mannitol (E421) Threonine Polysorbate 80 Sodium citrate (għall- korrezzjoni tal- pH) Hydrochloric acid konċentrat (għall- korrezzjoni tal- pH)
6.3 Shelf life
105 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Reconstituted solution: after reconstitution the chemical and physical in-use stability has been demonstrated for 14 hours at 25°C, including infusion time.
Wara li jitħallat l- istabilità kimika u fiżika waqt l- użu intweriet għal 14- il siegħa f’ temperatura ta ’ 25ºC, inkluż il- ħin ta ’ l- infużjoni.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih, il- ħin ta ’ ħażna u l- kundizzjonijiet qabel l- użu huma r- responsabbiltà ta ’ min qed jużah u s- soltu ma jkunx aktar minn 24 siegħa bejn 2 u 8ºC, sakemm it- taħlita ma tkunx saret taħt kundizzjonijiet ikkontrollati u validati asettiċi.
Store in a refrigerator (2 °C – 8 °C).
Aħzen fi friġġ (2ºC- 8ºC).
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rrikostitwit, ara sezzjoni 6. 3.
Clear type I glass vial sealed with bromobutyl rubber stopper and aluminium overseal with peach-coloured flip-off bonnet.
Kunjett issiġillat tal- ħġieġ ċar tat- tip I b’ tapp tal- gomma bromobutyl u aluminium jiksi s- siġill b’ għatu kulur il- ħawħ li tiftħu b’ saba.
Each vial contains 100 mg TMZ.
Kull kunjett fih 100 mg TMZ.
Temodal 2.5 mg/ml is supplied as a pack of 1 vial.
Temodal 2. 5 mg/ ml jiġi f’ pakkett ta ’ kunjett wieħed.
Caution must be exercised in handling Temodal 2.5 mg/ml powder for solution for infusion.
Wieħed għandu joqgħod attent meta juża Temodal 2. 5 mg/ ml trab għal soluzzjoni għall- infużjoni.
The use of gloves and aseptic technique is required.
L - użu ta ’ ingwanti u teknika asettika huma meħtieġa.
If Temodal 2.5 mg/ml comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Jekk Temodal 2. 5 mg/ ml jiġi f’ kuntatt mal- ġilda jew mukuża, irid jinħasel mill- ewwel u sew bl- ilma u s- sapun.
Each vial must be reconstituted with 41 ml sterilised water for injections.
Kull kunjett irid jiġi mħallat b’ 41 ml ilma għall- injezzjonijiet sterilizzat.
The resulting solution contains 2.5 mg/ml TMZ.
Is- soluzzjoni li tifforma jkun fiha 2. 5 mg/ ml TMZ.
The vials should be gently swirled and not shaken.
Il- kunjetti għandhom jiġu irrumblati bil- galbu u mhux imħallta bil- qawwa.
The solution should be inspected and any vial containing visible particulate matter should not be used.
Is - soluzzjoni għandha tiġi miflija u kwalunkwe kunjett li jkun fih xi frak m’ għandux jintuża.
A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into
Volum sa 40 ml tas- soluzzjoni mħallta għandu jinġibed, skond id- doża totali ordnata u ttrasferit ġo borża ta ’ l - infużjoni vojta tal- PVC ta ’ 250 ml.
Studies with non-PVC bags have not been conducted.
Ma sarux studji bil- boroz li ma jkunux tal- PVC.
The pump tubing should be attached to the bag, the tubing purged and then capped.
Il- pajp tal- pompa għandu jitwaħħal mal- borża, it- tubi mlaħalħa bis- soluzzjoni u imbagħad magħluqa.
Temodal 2.5 mg/ml must be administered by intravenous infustion only over a period of 90 minutes.
Temodal 2. 5 mg/ ml għandu jingħata biss permezz ta ’ infużjoni għal- ġol vina fuq perijodu ta ’ 90 minuta.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or infused simultaneously through the same intravenous line.
Fin- nuqqas ta ’ studji dwar kompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn jew jingħata fl- istess tubi li intużaw għal infużjoni oħra.
This medicinal product is for single use only.
Dan il- prodott mediċinali huwa għal użu ta ’ darba biss.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kwalunkwe prodott jew materjal ta ’ skart għandu jintrema skond il- liġijiet lokali.
EU/1/98/096/023
106 EU/ 1/ 98/ 096/ 023
107 A.
107 ANNESS II
Name and address of the manufacturer responsible for batch release:
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott.
Pharmacovigilance system
Sistema ta ’ Pharmakoviġilanza
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
L- MAH għandu jaċċerta ruħu li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 2. 0 ippreżentata f’ Modulu 1. 8. 1 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun f’ postha u taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan
Pjan ta ’ L- Imaniġġjar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
L- MAH jintrabat li jagħmel l- istudji u l- attivitajiet l- oħra ta ’ farmakoviġilanza ddettaljati fil- Pjan ta ’ Farmakoviġilanza, hekk kif miftiehem fil- verżjoni 2 tal- Pjan ta ’ l- Immaniġġjar tar- Riskju (RMP) ppreżentat f’ Modulu 1. 8. 2 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornament ieħor ta ’ l- RMP li jsir wara, hekk kif miftiehem mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP fuq is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għall- prodotti mediċinali għall- użu fil- bnedmin, l- RMP aġġornat għandu jiġi sottomess fl- istess żmien mar- Rapport Perijodiku Aġġjornat dwar is- Sigurtà (PSUR).
In addition, an updated RMP should be submitted
Minbarra hekk, RMP aġġornat għandu jiġi sottomess
- When new information is received that may impact on the current Safety Specification,
- Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti,
Pharmacovigilance Plan or risk minimisation activities
Pjan ta ’ Farmakoviġilanza jew attivitajiet li jimminimizzaw ir- riskju
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
- Fi żmien 60 jum minn meta jinkiseb avveniment importanti (ta ’ farmakoviġilanza jew ta ’
- At the request of the EMEA
minimizzar tar- riskju)
LABELLING AND PACKAGE LEAFLET
- Fuq talba ta ’ l- EMEA
109 A.
109 ANNESS III
110 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg
KARTUNA LI JKUN FIHA FLIXKUN 1 TA ’ 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 5 mg
Temodal 5 mg hard capsules Temozolomide
Kapsuli iebsin Temodal 5 mg Temozolomide
Each hard capsule contains 5 mg temozolomide
Kull kapsula iebsa fiha 5 mg ta ’ temozolomide.
See package leaflet for further information.
Aqra l- fuljett ta ’ tagħrif għal aktar informazzjoni.
5 hard capsules 20 hard capsules
5 kapsuli iebsin 20 kapsula iebsa
Keep out of the reach and sight of children, preferably in a locked cupboard.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal, l- aħjar f’ armarju maqful.
Cytotoxic Do not open, crush or chew the capsules, swallow whole.
Ċitotossiku Tiftaħx, tgħaffiġx jew tgħomodx il- kapsuli, iblagħhom sħaħ.
If a capsule is damaged, avoid contact with your skin, eyes or nose.
Jekk il- kapsula tinkiser, evita l- kuntatt mal- ġilda, għajnejn jew imnieħer.
111 Store in the original bottle in order to protect from moisture.
112 Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- flixkun oriġinali sabiex tilqa ’ mill- umdità.
EU/1/98/096/001 (5 hard capsules) EU/1/98/096/002 (20 hard capsules)
EU/ 1/ 98/ 096/ 001 (5 kapsuli iebsin) EU/ 1/ 98/ 096/ 002 (20 kapsula iebsa)
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
113 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg
KARTUNA LI JKUN FIHA FLIXKUN 1 TA ’ 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 20 mg
Temodal 20 mg hard capsules Temozolomide
Kapsuli iebsin Temodal 20 mg Temozolomide
Each hard capsule contains 20 mg temozolomide
Kull kapsula iebsa fiha 20 mg ta ’ temozolomide.
113 Store in the original bottle in order to protect from moisture.
114 Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- flixkun oriġinali sabiex tilqa ’ mill- umdità.
EU/1/98/096/003 (5 hard capsules) EU/1/98/096/004 (20 hard capsules)
EU/ 1/ 98/ 096/ 003 (5 kapsuli iebsin) EU/ 1/ 98/ 096/ 004 (20 kapsula iebsa)
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg
KARTUNA LI JKUN FIHA FLIXKUN 1 TA ’ 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 100 mg
Temodal 100 mg hard capsules Temozolomide
Kapsuli iebsin Temodal 100 mg Temozolomide
Each hard capsule contains 100 mg temozolomide
Kull kapsula iebsa fiha 100 mg ta ’ temozolomide.
115 Store in the original bottle in order to protect from moisture.
116 Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- flixkun oriġinali sabiex tilqa ’ mill- umdità.
EU/1/98/096/005 (5 hard capsules) EU/1/98/096/006 (20 hard capsules)
EU/ 1/ 98/ 096/ 005 (5 kapsuli iebsin) EU/ 1/ 98/ 096/ 006 (20 kapsula iebsa)
116 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg
KARTUNA LI JKUN FIHA FLIXKUN 1 TA ’ 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 140 mg
Temodal 140 mg hard capsules Temozolomide
Kapsuli iebsin Temodal 140 mg Temozolomide
Oral use Read the enclosed package leaflet before use.
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Accidental -ingestion can be lethal for children.
Jekk jibilgħuh b’ mod aċċidentali jista ’ joqtolhom.
117 Store in the original bottle in order to protect from moisture.
118 Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- flixkun oriġinali sabiex tilqa ’ mill- umdità.
EU/1/98/096/009 (5 hard capsules) EU/1/98/096/010 (20 hard capsules)
EU/ 1/ 98/ 096/ 009 (5 kapsuli iebsin) EU/ 1/ 98/ 096/ 0010 (20 kapsula iebsa)
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
119 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg
KARTUNA LI JKUN FIHA FLIXKUN 1 TA ’ 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 180 mg
Temodal 180 mg hard capsules Temozolomide
Kapsuli iebsin Temodal 180 mg Temozolomide
Store in the original bottle in order to protect from moisture.
120 Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- flixkun oriġinali sabiex tilqa ’ mill- umdità.
EU/1/98/096/011 (5 hard capsules) EU/1/98/096/012 (20 hard capsules)
EU/ 1/ 98/ 096/ 011 (5 kapsuli iebsin) EU/ 1/ 98/ 096/ 012 (20 kapsula iebsa)
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
121 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg
KARTUNA LI JKUN FIHA FLIXKUN 1 TA ’ 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 250 mg
Temodal 250 mg hard capsules Temozolomide
Kapsuli iebsin Temodal 250 mg Temozolomide
Each hard capsule contains 2 50 mg temozolomide
Kull kapsula iebsa fiha 250 mg ta ’ temozolomide.
121 Store in the original bottle in order to protect from moisture.
122 Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- flixkun oriġinali sabiex tilqa ’ mill- umdità.
EU/1/98/096/007 (5 hard capsules) EU/1/98/096/008 (20 hard capsules)
EU/ 1/ 98/ 096/ 07 (5 kapsuli iebsin) EU/ 1/ 98/ 096/ 08 (20 kapsula iebsa)
LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg
TIKKETTA GĦALL- FLIEXKEN LI JKUN FIHOM 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 5 mg
Temodal 5 mg hard capsules Temozolomide Oral use
Kapsuli iebsin Temodal 5 mg Temozolomide Użu orali
123 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
124 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg
TIKKETTA GĦALL- FLIEXKEN LI JKUN FIHOM 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 20 mg
Temodal 20 mg hard capsules Temozolomide Oral use
Kapsuli iebsin Temodal 20 mg Temozolomide Użu orali
124 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg
TIKKETTA GĦALL- FLIEXKEN LI JKUN FIHOM 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 100 mg
Temodal 100 mg hard capsules Temozolomide Oral use
Kapsuli iebsin Temodal 100 mg Temozolomide Użu orali
LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg
TIKKETTA GĦALL- FLIEXKEN LI JKUN FIHOM 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 140 mg
Temodal 140 mg hard capsules Temozolomide Oral use
Kapsuli iebsin Temodal 140 mg Temozolomide Użu orali
126 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
127 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg
TIKKETTA GĦALL- FLIEXKEN LI JKUN FIHOM 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 180 mg
Temodal 180 mg hard capsules Temozolomide Oral use
Kapsuli iebsin Temodal 180 mg Temozolomide Użu orali
127 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
128 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg
TIKKETTA GĦALL- FLIEXKEN LI JKUN FIHOM 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 250 mg
Temodal 250 mg hard capsules Temozolomide Oral use
Kapsuli iebsin Temodal 250 mg Temozolomide Użu orali
128 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
129 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg INDIVIDUALLY SEALED IN SACHETS
KARTUNA LI JKUN FIHA 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 20 mg QRATAS ISSIĠILLATI B’ MOD INDIVIDWALI
5 hard capsules in sachets 20 hard capsules in sachets
5 kapsuli iebsin fi qratas 20 kapsula iebsa fi qratas
129 Do not store above 30 °C.
130 Taħżinx f’ temperatura ’ l fuq minn 30°C
EU/1/98/096/013 (5 hard capsules) EU/1/98/096/014 (20 hard capsules)
EU/ 1/ 98/ 096/ 013 (5 kapsuli iebsin) EU/ 1/ 98/ 096/ 014 (20 kapsula iebsa)
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
131 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg INDIVIDUALLY SEALED IN SACHETS
KARTUNA LI JKUN FIHA 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 100 mg QRATAS ISSIĠILLATI B’ MOD INDIVIDWALI
131 Do not store above 30 °C.
132 Taħżinx f’ temperatura ’ l fuq minn 30°C
EU/1/98/096/015 (5 hard capsules) EU/1/98/096/016 (20 hard capsules
EU/ 1/ 98/ 096/ 015 (5 kapsuli iebsin) EU/ 1/ 98/ 096/ 016 (20 kapsula iebsa)
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
133 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg INDIVIDUALLY SEALED IN SACHETS
KARTUNA LI JKUN FIHA 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 140 mg QRATAS ISSIĠILLATI B’ MOD INDIVIDWALI
133 Do not store above 30 °C.
134 Taħżinx f’ temperatura ’ l fuq minn 30°C
EU/1/98/096/017 (5 hard capsules) EU/1/98/096/018 (20 hard capsules)
EU/ 1/ 98/ 096/ 017( 5 kapsuli iebsin) EU/ 1/ 98/ 096/ 018( 20 kapsula iebsa)
134 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg INDIVIDUALLY SEALED IN SACHETS
KARTUNA LI JKUN FIHA 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 180 mg QRATAS ISSIĠILLATI B’ MOD INDIVIDWALI
1.
135 1.
135 Do not store above 30 °C.
Taħżinx f’ temperatura ’ l fuq minn 30°C
EU/1/98/096/019 (5 hard capsules) EU/1/98/096/020 (20 hard capsules)
EU/ 1/ 98/ 096/ 019( 5 kapsuli iebsin) EU/ 1/ 98/ 096/ 020( 20 kapsula iebsa)
136 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg INDIVIDUALLY SEALED IN SACHETS
KARTUNA LI JKUN FIHA 5 JEW 20 KAPSULA IEBSA TA ’ TEMODAL 250 mg QRATAS ISSIĠILLATI B’ MOD INDIVIDWALI
Temodal 250 mg hard capsules Temozolomide
Kapsuli iebsin Temodal 250 mg
Accidental ingestion can be lethal for children.
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
137 Do not store above 30 °C.
Taħżinx f’ temperatura ’ l fuq minn 30°C
SP Europe Rue de Stalle 73 B-1180 Bruxelles, Belgium
138 SP Europe Rue de Stalle 73 B- 1180 Bruxelles, Il- Belġju
EU/1/98/096/021 (5 hard capsules) EU/1/98/096/022 (20 hard capsules)
EU/ 1/ 98/ 096/ 021( 5 kapsuli iebsin) EU/ 1/ 98/ 096/ 022( 20 kapsula iebsa)
138 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
139 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 20 mg
QARTAS LI JKUN FIH KAPSULA IEBSA 1 TA ’ TEMODAL 20 mg
1 hard capsule
1 kapsuli iebsin
139 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
140 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 100 mg
QARTAS LI JKUN FIH KAPSULA IEBSA 1 TA ’ TEMODAL 100 mg
SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 140 mg
QARTAS LI JKUN FIH KAPSULA IEBSA 1 TA ’ TEMODAL 140 mg
141 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
142 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 180 mg
QARTAS LI JKUN FIH KAPSULA IEBSA 1 TA ’ TEMODAL 180 mg
142 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
143 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 250 mg
QARTAS LI JKUN FIH KAPSULA IEBSA 1 TA ’ TEMODAL 250 mg
143 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
144 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Temodal 2.5 mg/ml powder for solution for infusion Temozolomide
Temodal 2. 5 mg/ ml trab għal soluzzjoni għall- infużjoni Temozolomide
Each vial contains 100 mg temozolomide.
Kull kunjett fih 100 mg ta’ temozolomide.
After reconstitution, 1 ml of solution for infusion contains 2.5 mg temozolomide.
Wara li jkun irrikostitwit, ml 1 ta ’ soluzzjoni għall- infużjoni jkun fih 2. 5 mg temozolomide.
Excipients: mannitol (E421), threonine, polysorbate 80, and sodium citrate and hydrochloric acid concentrated for pH adjustment.
Sustanzi mhux attivi: mannitol (E421), threonine, polysorbate 80, u sodium citrate u hydrochloric acid konċentrat għall- korrezzjoni tal- pH.
For sodium, see leaflet for further information.
Għas- sodium, ara l- fuljett għal aktar tagħrif.
Powder for solution for infusion 1 vial of 100 mg temozolomide
Trab għal soluzzjoni għall- infużjoni Kunjett 1 ta ’ 100 mg temozolomide
Intravenous use only.
Użu għal ġol- vina biss.
Cytotoxic Avoid contact with skin, eyes or nose.
Ċitotossiku Evita kuntatt mal- ġilda, għajnejn jew imnieħer.
EXP After reconstitution, use the solution within 14 hours at 25°C, including infusion time.
JIS Wara li jitħallat, uża s- soluzzjoni fi żmien 14- il siegħa f’ 25ºC, inkluż il- ħin ta ’ l- injezzjoni.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kwalunkwe prodott li ma jintużax jew skart għandu jintrema ’ skond il- liġijiet lokali.
145 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
146 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
148 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
Temodal 5 mg hard capsules temozolomide
Temodal 5 mg kapsuli iebsin temozolomide
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Temodal is and what it is used for 2.
X’ inhu Temodal u għalxiex jintuża 2.
Before you take Temodal 3.
Qabel ma tieħu Temodal 3.
How to take Temodal 4.
Kif għandek tieħu Temodal 4.
How to store Temodal 6.
Kif taħżen Temodal 6.
WHAT TEMODAL IS AND WHAT IT IS USED FOR
X’ INHU TEMODAL U GĦALXIEX JINTUŻA
Temodal is an antitumour agent.
Temodal huwa prodott mediċinali kontra t- tumuri.
Temodal is used for the treatment of patients with specific forms of brain tumours:
Temodal jintuża għal kura ta ’ pazjenti b’ tumuri speċifiċi tal- moħħ:
- newly-diagnosed glioblastoma multiforme.
- glioblastoma multiforme li tkun għada kif ġiet dijanjostikata:
Temodal is first used together with radiotherapy
Temodal l- ewwel jintuża ma ’
(concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
radjuterapija (fażi konkomitanti tal- kura) u mbagħad waħdu (fażi ta ’ kura b’ monoterapija).
- malignant glioma, such as glioblastoma mult iforme or anaplastic astrocytoma.
- glijoma malinna, bħall glioblastoma multiforme u astroċitoma anaplastika:
Temodal is used in
Temodal jintuża
these tumours if they return or get worse after standard treatment.
f’ dawn it- tumuri jekk jerġgħu joħorġu jew imorru għall- agħar wara kura standard.
BEFORE YOU TAKE TEMODAL
QABEL MA TIEĦU TEMODAL
Do not take Temodal
Tieħux Temodal
- if you are allergic (hypersensitive) to temozolomide or any of the other ingredients of Temodal.
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għal temozolomide jew sustanzi oħra ta ’
- if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called
- jekk kellek reazzjoni allerġika għal dacarbazine (kura kontra l- kanċer, kultant imsejħa DTIC).
Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Sinjali ta ’ reazzjoni allerġika jinkludu ħakk, qtugħ ta ’ nifs jew tħarħir, nefħa tal- wiċċ, xofftejn, ilsien jew grieżem.
- if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood
- jekk ċerti tipi ta ’ ċelluli tad- demm jonqsu b’ mod serju (majelosuppressjoni), bħal meta l- għadd
cell count and platelet count.
taċ- ċelluli l- bojod tad- demm u l- għadd tal- plejtlets jitbaxxa.
These blood cells are important for fighting infection and for proper blood clotting.
Dawn iċ- ċelluli tad- demm huma importanti biex tiġġieled l- infezzjoni u biex jagħqad id- demm kif suppost.
Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
- Qabel tibda l- kura, it- tabib tiegħek ser janalizza d- demm biex ikum żgur li għandek biżżejjed
Take special care with Temodal
Oqgħod attent ħafna b’ Temodal
- you should be observed closely for the development of a serious form of pneumonia called
- trid tinżamm taħt osservazzjoni stretta għall- iżvilupp ta ’ forma serja ta ’ pulmonite imsejħa
Pneumocystis carinii pneumonia (PCP).
pulmonite bi Pneumocystis carinii (PCP).
If you are a newly -diagnosed patient (glioblastoma multiforme) you may be receiving Temodal for 42 days in combination with radiotherapy.
Jekk int pazjent li għadek kif ġejt dijanjostikat (glijoblastoma multiforme) tista ’ tingħata Temodal għal 42 jum flimkien ma ’ radjuterapija.
In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).
F’ dan il- każ, it- tabib tiegħek ser jordnalek ukoll mediċina biex tgħinek tevita din it- tip ta ’ pnewmonja (PCP).
- if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood
- jekk għandek għadd baxx ta ’ ċelluli ħomor tad- demm (anemija), ċelluli bojod tad- demm u
clotting problems before starting the treatment, or if you develop them during treatment.
plejtlets jew problemi biex tgħaqqad id- demm qabel ma tibda l- kura, jew jekk int tiżviluppahom waqt il- kura.
Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.You may also need other treatments.
It- tabib tiegħek jista ’ jiddeċiedi li jnaqqas id- doża, iwaqqaf għal ftit jew għal
In some cases, it may be necessary to stop treatment with Temodal.
F’ ċerti każi, jista ’ jkun hemm bżonn li t- trattament b’ Temodal jitwaqqaf.
Your blood will be tested frequently during treatment to monitor the side effects of Temodal on your blood cells.
Ser isirulek testijiet tad- demm ta ’ sikwit waqt il- kura sabiex ikunu immonitorjati l- effetti sekondarji ta ’ Temodal fuq iċ- ċelluli tad- demm tiegħek.
- you may have a small risk of other changes in blood cells, including leukaemia.
- jista ’ jkollok riskju żgħir ta ’ bidliet oħra fiċ- ċelluli tad- demm, inkluża lewkemija.
- if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side
- jekk ikollok dardir (tħoss l- istonku mhux f’ postu) u/ jew rimettar, li huma assoċjati ta ’ spiss ma ’
effects of Temodal (see section 4 “Possible side effects”), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
l- effetti sekondarji ta ’ Temodal (ara sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu ”), it- tabib tiegħek jista ’ jordnalek mediċina (anti- emetika) biex tgħinek tevita r- rimettar.
If you vomit frequently before or during treatment, ask your doctor about the best time to take Temodal until the vomiting is under control.
Jekk tirremetti ta ’ spiss qabel jew waqt il- kura, staqsi lit- tabib tiegħek dwar l- aħjar ħin biex tieħu Temodal sakemm ir- rimettar ikun ikkontrollat.
If you vomit after taking your dose, do not take a second dose on the same day.
Jekk tirremetti wara li tieħu d- doża, terġax tieħu doża oħra fl- istess ġurnata.
- if you develop fever or symptoms of an infection contact your doctor immediately.
- jekk jitlagħlek id- deni jew joħorġulek is- sintomi ta ’ infezzjoni għamel kuntatt mat- tabib tiegħek
- do not open, crush or chew the capsules.
- tiftaħx, tifqax jew togħmodx il- kapsuli.
If a capsule is damaged, avoid contact of the powder
Jekk il- kapsula tinkiser evita l- kuntatt tat- trab li jkun
with your skin, eyes or nose.
fiha mal- ġilda, għajnejn u mnieħer.
Avoid inhaling the powder.
Evita li tiġbed it- trab man- nifs.
If you accidentally get some in your eyes or nose, flush the area with water.
Jekk b’ mod aċċidentali ddaħħal xi trab f' għajnejk jew f’ imnieħrek, aħsel il- parti bl- ilma.
- if you are older than 70 years of age, you might be more prone to infection, bruising or bleeding.
- jekk għandek aktar minn 70 sena jista ’ jkollok tendenza akbar li taqbdek infezzjoni jew
- if you have liver or kidney problems, your dose of Temodal may need to be adjusted.
- jekk għandek problemi tal- fwied jew tal- kliewi, id- doża tiegħek ta ’ Temodal jista ’ jkollha bżonn
Due to lack of experience, Temodal should not be used in children younger than 3 years.
Minħabba nuqqas ta ’ esperjenza, Temodal m’ għandux jintuża fi tfal taħt it- tlett snin.
Temodal may cause permanent infertility.
Temodal jista ’ jikkawża infertilità permanenti.
Male patients should use effective contraceptions and not father a child for up to 6 months after stopping treatment.
Pazjenti irġiel għandhom jużaw kontraċezzjonijiet effettivi u m’ għandux ikollhom tfal sa 6 xhur wara li jwaqqfu l- kura.
It is recommended to seek advice on conservation of sperm prior to treatment.
Huwa irrakkomandat li jinkiseb parir dwar il- konservazzjoni ta ’ l- isperma qabel il- kura.
Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you might be or are planning to get pregnant.
Tqala u treddigħ Għid lit- tabib tieghek jekk ħriġt tqila, taħseb li ħriġt tqila jew qed tippjana għat- tqala.
You must not be treated with Temodal during pregnancy unless clearly indicated by your doctor.
M’ għandekx tiġi kkurata b’ Temodal waqt it- tqala sakemm ma jkunx indikat b’ mod ċar mit- tabib tiegħek.
Effective contraceptive precautions must be taken by both male and female patients who are taking Temodal (see also “Take special care with Temodal” above).
Prewkawzjonijiet kontraċettivi effettivi huma rrakkomandati kemm għall- pazjenti irġiel u kemm nisa li qed jieħdu Temodal (ara wkoll “ Oqgħod attent ħafna b’ Temodal ” hawn fuq).
You should stop breast-feeding while receiving treatment with Temodal.
Għandek tieqaf tredda ’ meta tkun qed tirċievi kura b’ Temodal.
Driving and using machines Temodal may make you feel tired or sleepy.
Sewqan u tħaddim ta ’ magni Temodal jista ’ jagħmlek tħossok għajjien jew bi ngħas.
In this case, do not drive or use any tools or machines.
F’ dan il- każ, issuqx jew tħaddimx xi għodda jew magni.
Important information about some of the ingredients of Temodal Temodal hard capsules contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Temodal Temodal kapsuli iebsin fihom lactose.
HOW TO TAKE TEMODAL
KIF GĦANDEK TIEĦU TEMODAL
Dosage and duration of treatment
Dosaġġ u tul tal- kura
Your doctor will work out your dose of Temodal.
It- tabib tiegħek għandu jikkalkula d- doża korretta ta ’ Temodal.
This is based on your size (height and weight) and if you have a recurrent tumour and have had chemotherapy treatment in the past.
Din hija bbażata skond id- daqs tiegħek (tul u piż), jekk għandekx tumur rikurrenti u jekk kellekx trattament bil- kemoterapija fil- passat.
You may be given other medicines (anti-emetics) to take before and/or after taking Temodal to prevent or control nausea and vomiting.
Jistgħu jingħatawlek medikazzjonijiet oħra (anti emetiċi) biex tieħodhom qabel u/ jew wara li tieħu Temodal biex tevita jew tikkontrolla d- dardir u r- rimettar.
Patients with newly-diagnosed glioblastoma multiforme:
Pazjenti li jkunu għadhom kif ġew dijanjostikati bi glioblastoma multiforme:
If you are a newly-diagnosed patient, treatment will occur in two phases:
151 Jekk int pazjent li għadek kif ġejt dijanjostikat, il- kura ser isseħħ f’ żewġ fażijiet:
- treatment together with radiotherapy (concomitant phase) first
- kura ma ’ radjuterapija (il- fażi konkomitanti) l- ewwel
- followed by treatment with only Temodal (monotherapy phase).
- segwita b’ Temodal waħdu (il- fażi ta ’ monoterapija).
During the concomitant phase, your doctor will start Temodal at a dose of 75 mg/m2 (usual dose).
Waqt il- fażi konkomitanti, it- tabib tiegħek ser jibdielek Temodal b’ doża ta ’ 75 mg/ m2 (doża tas- soltu).
The
Ser tieħu din id- doża kuljum għal 42 jum (sa 49 jum) flimkien ma ’ radjuterapija.
150 Temodal dose may be delayed or stopped, depending on you blood counts and how you tolerate your medicine during the concomitant phase.
Id- doża ta ’ Temodal tista ’ tkun ittardjata jew imwaqqfa, skond l- għadd taċ- ċelluli tad- demm u kemm tiflaħ tieħu l- mediċina waqt il- fażi konkomitanti.
Once the radiotherapy is completed, you will interrupt treatment for 4 weeks.
Meta r- radjuterapija tkun kompleta, twaqqaf il- kura għal 4 ġmgħat.
This will give your body a chance to recover.
Dan jagħtik ftit żmien sabiex ġismek jerġa ’ jirkupra.
Then, you will start the monotherapy phase.
Imbagħad ser tibda il- fażi ta ’ monoterapija.
During the monotherapy phase, the dose and way you take Temodal will be different.
Waqt il- fażi ta ’ monoterapija id- doża u l- mod kif tingħata Temodal f’ din l- fażi ser tkun differenti.
Your doctor will work out your exact dose.
It - tabib tiegħek ser jikkalkula id- doża eżatta għalik.
There may be up to 6 treatment periods (cycles).
Jista ’ jkun hemm sa 6 perijodi ta ’ kura (ċikli).
Each one lasts 28 days.
Kull wieħed idum 28 jum.
You will take your new dose of Temodal alone once daily for the first 5 days (“dosing days”) of each cycle.
Ser tieħu d- doża l- ġdida ta ’ Temodal waħdu għall- ewwel ħamest ijiem (“ ġranet tad- doża ”) ta ’ kull ċiklu.
The first dose will be 150 mg/m2.
L- ewwel doża se tkun ta ’ 150 mg/ m2.
Then you will have 23 days without Temodal.
Imbagħad ikollok 23 jum mingħajr Temodal.
This adds up to a 28- day treatment cycle.
Dan b’ kollox ikun ċiklu ta ’ kura ta ’ 28 jum.
After Day 28, the next cycle will begin.
Wara Jum 28, jibda ċ- ċiklu li jmiss.
You will again take Temodal once daily for 5 days followed by 23 days without Temodal.
Ser terġa ’ tieħu Temodal darba kuljum għal ħamest ijiem segwit bi 23 jum mingħajr Temodal.
The Temodal dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Id- doża ta ’ Temodal tista ’ tkun irranġata, ittardjata jew imwaqqfa għal kollox skond il- għadd taċ- ċelluli tad- demm tiegħek u/ jew kemm tkun tiflaħ għall- mediċina tiegħek f’ kull ċiklu ta ’ kura.
Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temodal only:
Pazjenti b’ tumuri li reġgħu ħarġu jew aggravaw (glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika) li qed jieħdu Temodal biss:
A treatment cycle with Temodal lasts 28 days.
Ċiklu ta ’ kura b’ Temodal jinkludi 28 jum.
You will take Temodal alone once daily for the first 5 days.
Ser tieħu Temodal waħdu darba kuljum għall- ewwel ħamest ijiem.
This daily dose depends on whether or not you have received chemotherapy before.
Din id- doża ta ’ kuljum tiddependi fuq jekk irċevejtx kimoterapija minn qabel jew le.
If you have not been previously treated with chemotherapy, your first dose of Temodal will be 200 mg/m2 once daily for the first 5 days.
Jekk qatt ma kellek kura b’ kimoterapija, l- ewwel doża ta ’ Temodal se tkun ta ’ 200 mg/ m2 darba kuljum għall- ewwel ħamest ijiem.
If you have been previously treated with chemotherapy, your first dose of Temodal will be 150 mg/m2 once daily for the first 5 days.
Jekk xi darba qabel kellek kura b’ kimoterapija, l- ewwel doża ta ’ Temodal se tkun ta ’ 150 mg/ m2 darba kuljum għall- ewwel ħamest ijiem.
Then, you will have 23 days without Temodal.
Imbagħad ser jkollok 23 jum mingħajr Temodal.
This adds up to a 28-day treatment cycle.
Dan jammonta għal ċiklu ta ’ kura ta ’ 28 jum.
You will again receive Temodal once daily for 5 days, followed by 23 days without Temodal.
Ser terġa tirċievi Temodal darba kuljum għal ħamest ijiem, segwit minn 23 jum mingħajr Temodal.
Before each new treatment cycle, your blood will be tested to see if the Temodal dose needs to be adjusted.
Qabel kull ċiklu ġdid ta ’ kura, id- demm tiegħek jiġi eżaminat bex jaraw jekk id- doża ta ’ Temodal għandhiex bżonn tinbidel.
Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Skond ir- riżultati tat- testijiet tad- demm, it- tabib jista ’ jirranġa d- doża għaċ - ċiklu li jmiss.
How to take Temodal
Kif tieħu Temodal
Take your prescribed dose of Temodal once a day, preferably at the same time each day.
Ħu d- doża ta ’ Temodal li ordnawlek darba kuljum, l- aħjar kuljum fl- istess ħin tal- ġurnata.
Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Ħu l- kapsuli fuq stonku vojt; per eżempju, mill- anqas siegħa qabel ma tkun biħsiebek tieħu l - kolazzjon.
Swallow the capsule(s) whole with a glass of water.
Ibla ’ l- kapsula( i) sħiħa/ sħaħ ma ’ tazza ilma.
Do not open or chew the capsules.
Tiftaħx jew tomgħodx il- kapsuli.
If a capsule is damaged, avoid contact with your skin, eyes or nose.
Jekk kapsula tkun imxaqqa, evita li tgħamel kuntatt mal- ġilda, għajnejn jew imnieħer.
If it occurs, wash the affected area thoroughly.
Jekk jiġri hekk, aħsel sew il - parti effettwata.
Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg).
Skond id- doża li jordnawlek, jista ’ jkollok bżonn tieħu aktar minn kapsula waħda f’ daqqa, u maż - żmien b’ qawwiet differenti (kontenut tas- sustanza attiva, f’ mg).
The colour of the capsule cap is different for each strength (see in the table below).
Il- kulur tal- qoxra tal- kapsula huwa differenti għal kull qawwa (ara t- tabella hawn taħt).
Colour of the cap
Kulur tal- qoxra
Temodal
152
5 mg hard capsules
5 mg kapsuli iebsin 20 mg kapsuli iebsin 100 mg kapsuli iebsin 140 mg kapsuli iebsin
green
Temodal Temodal
Temodal 20 mg hard capsules Temodal 100 mg hard capsules Temodal 140 mg hard capsules Temodal 180 mg hard capsules Temodal 250 mg hard capsules
180 mg kapsuli iebsin 250 mg kapsuli iebsin
yellow pink blue orange white
oranġjo abjad
151 You should make sure you fully understand and remember the following: • how many capsules you need to take every dosing day.
Għandek taċċerta ruħek li tifhem eżattament u tiftakar dan li ġej: • kemm għandek bżonn tieħu kapsuli fil- ġranet tad- doża.
Ask your doctor or pharmacist to write it down (including the colour). • which days are your dosing days.
Staqsi lit- tabib jew lill- ispiżjar biex jiktbuhielek (inkluż il- kulur). • liema ġranet huma l- jiem tad- doża.
Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Irrevedi d- doża mat- tabib tiegħek kull darba li tibda ċiklu ġdid, minħabba li tista ’ tkun differenti mill - aħħar ċiklu.
Always take Temodal exactly as your doctor has told you.
Dejjem għandek tieħu Temodal skond il- parir eżatt tat- tabib.
It is very important to check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
Errors in how you take this medicine may have serious health consequences.
Jekk tiżbalja l- mod kif tieħu din il- mediċina, jista ’ jkun hemm konsegwenzi serji għal saħħtek.
If you take more Temodal than you should If you accidentally take more Temodal capsules than you were told to, contact your doctor or pharmacist immediately.
Jekk tieħu Temodal aktar milli suppost Jekk b’ mod aċċidentali tieħu aktar kapsuli Temodal milli kellek tieħu, ikkuntattja lit- tabib jew lill - ispiżjar tiegħek minnufih.
If you forget to take Temodal Take the missed dose as soon as possible during the same day.
Jekk tinsa tieħu Temodal Ħu d- doża li nsejt kemm jista ’ jkun malajr fl- istess ġurnata.
If a full day has gone by, check with your doctor.
Jekk tgħaddi ġurnata sħiħa, iċċekkja mat - tabib tiegħek.