qanastek/EMEA-V3 huggingface dataset:
Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu, sakemm it- tabib tiegħek ma jgħidlekx biex tagħmel hekk.
Like all medicines, Temodal can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Temodal jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kullħadd.
Contact your doctor immediately if you have any of the following:
Ikkuntattja lit- tabib tiegħek minnufih jekk ikollok kwalunkwe minn dawn li ġejjin:
- a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
- reazzjonijiet allergiċi serji (sensittività eċċessiva) (infafet, tħarħir jew xi problemi biex tieħu n -
- uncontrolled bleeding,
- emorraġija bla- kontroll,
- seizures (convulsions),
- aċċessjonijiet (konvulżjonijiet),
- a severe headache that does not go away.
- uġigħ ta ’ ras li ma jkunx irid jgħaddi.
Temodal treatment can cause a reduction in certain kinds of blood cells.
It- trattament b’ Temodal jista ’ jikkawża tnaqqis f’ ċerti tipi ta ’ ċelluli tad- demm.
This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
Dan jista ’ jikkawżalek żjieda fit- tbenġil jew emorraġġija, anemija (nuqqas ta ’ ċelluli ħomor tad- demm), deni, u tnaqqis fir - reżistenza għall- infezzjonijiet.
The reduction in blood cell counts is usually short-lived.
It- tnaqqis taċ- ċelluli fid- demm normalment ma jdumx.
In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
F’ xi każijiet jista ’ jieħu fit- tul u jista ’ jwassal għal forma serja ta ’ anemija (anemija aplastika).
Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed.
It- tabib tiegħek għandu jeżaminalek d- demm tiegħek b’ mod regolari għal xi tibdil, u ser jiddeċiedi jekk xi trattament speċifiku jkunx meħtieġ.
In some cases, your Temodal dose will be reduced or treatment stopped.
F’ xi każijiet, id- doża ta ’ Temodal tiegħek titnaqqas jew il- kura titwaqqaf.
Side effects from clinical studies:
Effetti sekondarji minn provi kliniċi:
Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
153 komuni ħafna: jeffettwa aktar minn 1 f’ kull 10 li jużawh komuni: jeffettwa minn 1 sa 10 minn kull 100 li jużawh mhux komuni: jeffettwa minn 1 sa 10 minn kull 1, 000 li jużawh rari: jeffettwa minn 1 sa 10 minn kull 10, 000 li jużawh rari ħafna: jeffettwa anqas minn 1 minn kull 10, 000 li jużawh mhux magħruf: frekwenza ma tistax tiġi stmata mid- dejta disponibbli.
Temodal in combination treatment with radiotherapy in newly-diagnosed glioblastoma Patients receiving Temodal in combination with radiotherapy may experience different side effects than patients taking Temodal alone.
Temodal f’ kurak kombinata ma ’ radjuterapija fi glioblastoma li tkun għadha kif ġiet dijanjostikata Pazjenti li qed jirċievu Temodal f’ kombinazzjoni ma ’ radjazzjoni jistgħu jħossu effetti sekondarji differenti minn pazjenti li qed jieħdu Temodal waħdu.
The following side effects may occur, and may require medical attention.
L- effetti sekondarji li ġejjin jistgħu jseħħu, u jista ’ jkollhom bżonn attenzjoni medika
152 Very common: loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Nuqqas ta’ l- aptit, uġigħ ta ’ ras, stitikezza (tbati biex tipporga), dardir (tħoss l- istonku mhux f’ postu), rimettar, raxx, jaqa ’ x- xagħar, għeja.
Common: oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Komuni: infezzjonijiet fil- ħalq, infezzjoni tal- ferita, jonqos l- għadd taċ- ċelluli tad- demm (newtropenja, tromboċitopenja, limfopenja, lewkopenja), jogħla z- zokkor fid- demm, titlef il- piż, bidla fl- istat mentali jew viġilanza, ansjetà/ dipressjoni, ngħas, diffikultajiet biex titkellem, l- ekwilibriju jiddgħajjef, sturdament, konfużjoni, tinsa ħafna, tbati biex tikkonċentra, ma tkunx tista ’ torqod jew tibqa rieqed, tingiż, titbenġel, rogħda, vista mhux normali jew imċajpra, tara doppju, problemi fis - smigħ, qtugħ ta ’ nifs, sogħla, demm magħqud fir- riġlejn, jiżdied l- ilma fil- ġisem, nefħa fir- riġlejn, dijarea, uġigħ fl- istonku jew fl- addome, ħruq ta ’ stonku, stonku mqalla, diffikulta ’ biex tibla ’, ħalq xott, irritazzjoni jew ħmura tal- ġilda, ġilda xotta, ħakk, dgħjufija fil- muskoli, uġigħ fil- ġogi, uġigħ fil - muskoli jew weġgħat, tagħmel awrina ta ’ spiss, diffikulta ’ biex iżżomm l- awrina, reazzjoni allerġika, deni, ħsara effett tar- raġġi nefħa fil- wiċċ, uġigħ, togħma anormali, testijiet tal- funzjoni tal- fwied mhux normali.
Uncommon: flu-like symptoms, red spots under the skin, appearance of a swollen face or muscle weakness, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, difficulty swallowing, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
Mhux komuni: sintomi li jixbhu l- influwenza, dbabar ħomor taħt il- ġilda, il- wiċċ jidher minfuħ jew dgħjufija tal- muskoli, livell baxx ta ’ potassium fid- demm, żieda fil- piż, bidla fil- burdati, alluċinazzjoni u memorja mhux eżatta, paraliżi parzjali, koordinazzjoni mxekkla, diffikulta ’ biex tibla ’, sensazzjonijiet imxekkla, telf parzjali tal- vista, għajnejn xotti jew bl- uġigħ, nuqqas ta ’ smigħ, infezzjoni fil- widna minn ġewwa, tisfir fil- widnejn, uġigħ fil- widnejn, palpitazzjonijiet (tferfir ta ’ qalb),, demm magħqud fil- pulmun, pressjoni tad- demm għolja, pulmonite, infjammazzjoni fis- sinuses, bronkite, riħ jew influwenza, l- istonku jintefaħ, tbati biex tikkontrolla l- purgar, morliti, ġilda misluħa, żieda fis- sensittività tal- ġilda għad- dawl tax- xemx, bidla fil- kulur tal- ġilda, żieda fl- għaraq, ħsara fil - muskoli, uġigħ fid- dahar, diffikulta ’ biex tgħaddi l- awrina, fsada tal- vaġina, impotenza sesswali, il - perjid ma jiġix jew tara aktar mis- soltu, irritazzjoni tal- vaġina, uġigħ fis- sider, fwawar ta ’ sħana, tertir, telf tal- kulur ta ’ l- ilsien, ma xxommx bħas- soltu, għatx, disturbi tas- snien.
Temodal monotherapy in recurrent or progressive glioma The following side effects may occur, and may require medical attention.
Monoterapija b’ Temodal fi glijoma rikurrenti jew progressiva L- effetti mhux mixtieqa li ġejjin jistgħu jseħħu, u jistgħu jeħtieġu attenzjoni medika.
Very common: reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools).
Komuni ħafna: tnaqqis fl- għadd taċ- ċelluli tad- demm (newtropenja u limfopenja, tromboċitopenja), telf ta ’ l- aptit, uġigħ ta ’ ras, rimettar, dardir (tħoss l- istonku mhux floku), stitikezza (tbati biex tipporga).
Common: loss of weight, tiredness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Komuni: telf tal- piż, għeja, sturdament, sensazzjoni ta ’ tingiż, qtugħ ta ’ nifs, dijarea, uġigħ ta ’ żaqq, stonku mqalla, raxx, ħakk, telf ta ’ xagħar, deni, dgħjufija, tregħid, tħossok ma tiflaħx, uġigħ, bidla fit - togħma.
Uncommon: reduced number of blood cell counts (pancytopenia, anaemia, leukopenia).
Mhux komuni: tnaqqis fl- għadd taċ- ċelluli tad- demm (panċitopenja, anemija, lewkopenja).
Rare: cough, infections including pneumonia.
Rari: sogħla, infezzjonijiet inklużi aġenti li jikkawżaw pulmonite.
Very rare: skin redness, urticaria (hives), skin eruption, allergic reactions.
Rari ħafna: ħmura tal- ġilda, urtikarja (ħobż ħobz), ponot fil- ġilda, reazzjonijiet allerġiċi.
Other side effects:
154 Effetti sekondarji oħrajn:
Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Każijiet rari ħafna ta ’ raxx sever b’ nefħa tal- ġilda, li tinkludi l- wiċċ ta ’ l- id u l- qiegħ tas- saqajn jew uġigħ bi ħmura tal- ġilda u/ jew bżieżaq fuq il- ġisem jew fil- ħalq kienu osservati.
Tell your doctor immediately if this occurs.
Għid lit- tabib tiegħek minnufih jekk dan iseħħ.
Very rare cases of lung side effects have been observed with Temodal.
Każijiet rari ħafna ta ’ effetti sekondarji tal- pulmun dehru b’ Temodal.
Patients usually present with shortness of breath and cough.
Il- pazjenti s- soltu jiġu bi qtugħ ta ’ nifs u sogħla.
Tell your doctor if you notice any of these symptoms.
Għid lit- tabib tiegħek jekk tinnota kwalunkwe minn dawn is- sintomi.
In very rare cases, patients taking Temodal and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
F’ każijiet rari ħafna, pazjenti li jieħdu Temodal u mediċini bħalu, jista ’ jkollhom riskju żgħir li jiżviluppaw kanċers sekondarji li jinkludi l- lewkimja.
HOW TO STORE TEMODAL
KIF TAHŻEN TEMODAL
Do not use Temodal after the expiry date which is stated on the label and carton.
Tużax Temodal wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
Store in the original bottle in order to protect from moisture.
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- flixkun oriġinali sabiex tilqa ’ mil- umdità.
Tell your pharmacist if you notice any change in the appearance of the capsules.
Għid lill- ispiżjar jekk tinnota xi tibdil fid- dehra tal- kapsuli.
Medicines should not be disposed of via wastewater of household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Temodal contains
X’ fih Temodal
- The active substance is temozolomide.
- Is- sustanza attiva hija temozolomide.
Each capsule contains 5 mg temozolomide.
Kull kapsula fiha 5 mg temozolomide.
- The other ingredients are:
- Is- sustanzi l- oħrajn huma:
capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
kontenut tal- kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
capsule shell: gelatin, titanium dioxide (E 171), sodium laurilsulfate, yellow iron oxide (E 172), indigo carmine (E 132).
qoxra tal- kapsula: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), indigo carmine (E 132).
printing ink: shellac, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, and black iron oxide (E 172).
inka ta ’ l- istampar: shellac, propylene glycol, ilma purifikat, ammonium hydroxide, potassium hydroxide, u black iron oxide (E172).
What Temodal looks like and contents of the pack
Id- Dehra ta ’ Temodal u l- kontenuti tal- pakkett
Temodal 5 mg hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.
Temodal 5 mg kapsuli iebsin għandhom parti opaka bajda, għatu opak aħdar, u huma stampati b’ inka sewda.
The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
Il- kapsuli iebsin għall- użu orali jiġu fi fliexken kannella jagħtu fl- oranġjo li jkun fihom 5 jew 20 kapsula.
Not all pack sizes may be marketed.
Il- kartuna fiha flixkun wieħed Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorization Holder and Manufacturer
155 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l’ Manifattur
Marketing Authorisation Holder:
Sid l- Awtorizzazzjoni għat- tqegħid fis- Suq:
SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium
SP Europe, Rue de Stalle 73, B- 1180 Bruxelles, Il- Belġju
SP Labo N.V., Industriepark 30, B- 2220 Heist-op-den-Berg, Belgium
SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Il- Belġju
België/Belgique/Belgien Rue de Stalle/Stallestraat 73 B-1180 Bruxelles/Brussel/Brüssel Tél/Tel: + 32-(0)2 370 92 11
België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B- 1180 Bruxelles/ Brussel/ Brüssel
България
Tél/ Tel: + 32 - (0) 2 370 92 11
Magyarország
B- 1180 Bruxelles/ Brüssel Belgique/ Belgien Tél/ Tel: + 32 - (0) 2 370 92 11
8, sector 1 RO-0136 82 Bucureşti Tel: + 40 21 233 35 30
8, sector 1 RO- 013682 Bucureşti
Italia Via fratalli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano)
Italia Suomi/ Finland Via fratalli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
156 PACKAGE LEAFLET:
157 FULJETT TA ’ TAGĦRIF:
Temodal 20 mg hard capsules temozolomide
Temodal 20 mg kapsuli iebsin temozolomide
- malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma.
- glijoma malinna, bħall glioblastoma multiforme u astroċitoma anaplastika:
- if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called
- jekk kellek reazzjoni allerġika għal dacarbazine (kura kontra l- kanċer, kulltant imsejħa DTIC).
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.
You should stop breast-feeding while receiving treatment with Temodal.
Għandek tieqaf tredda meta tkun qed tirċievi kura b’ Temodal.
Patients with newly-diagnosed glioblastoma multiforme:
Pazjenti li jkunu għadhom kif ġew dijanjostikati b’ i glioblastoma multiforme:
If you are a newly-diagnosed patient, treatment will occur in two phases:
159 Jekk int pazjent li għadek kif ġejt dijanjostikat, il- kura ser isseħħ f’ żewġ fażijiet:
158 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.
Temodal
160
159 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.
If you forget to take Temodal Take the missed dose as soon as possible during the same day.
Jekk tinsa tieħu Temodal Ħu doża li nsejt kemm jista ’ jkun malajr fl- istess ġurnata.
- uncontrolled bleeding,
- emorraġġija bla- kontroll,
Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
161 komuni ħafna: jeffettwa aktar minn 1 f’ kull 10 li jużawh komuni: jeffettwa minn 1 sa 10 minn kull 100 li jużawh mhux komuni: jeffettwa minn 1 sa 10 minn kull 1, 000 li jużawh rari: jeffettwa minn 1 sa 10 minn kull 10, 000 li jużawh rari ħafna: jeffettwa anqas minn 1 minn kull 10, 000 li jużawh mhux magħruf: frekwenza ma tistax tiġi stmata mid- dejta disponibbli.
160 Very common: loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Nuqqas ta’ l- aptit, uġigħ ta ’ ras, stitikezza (tbati biex tipporga), dardir (tħoss l- istonku mhux f’ postu), rimettar, raxx, jaqa ’ x- xagħar, għeja.
Other side effects:
162 Effetti sekondarji oħrajn:
Store in the original bottle in order to protect from moisture.
L- għamla tal- flixkun Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- flixkun oriġinali sabiex tilqa ’ mil- umdità.
Sachet presentation Do not store above 30°C.
Għamla tal- qartas Taħżinx f’ temperatura ’ l fuq minn 30°C
Each capsule contains 20 mg temozolomide.
Kull kapsula fiha 20 mg temozolomide.
- capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A,
kontenut tal- kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
- capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172),
qoxra tal- kapsula: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172)
hydroxide, and black iron oxide (E 172).
inka ta ’ l- istampar: shellac, propylene glycol, ilma purifikat, ammonium hydroxide, potassium hydroxide, u black iron oxide (E172).
Temodal 20 mg hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink.
Temodal 20 mg kapsuli iebsin għandhom parti opaka bajda, għatu opak isfar, u huma stampati b’ inka sewda.
Bottle presentation The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
163 Għamla tal- flixkun Il- kapsuli iebsin għall- użu orali jiġu fi fliexken kannella jagħtu fl- oranġjo li jkun fihom 5 jew 20 kapsula.
The carton contains one bottle.
Il- kartuna fiha flixkun wieħed
Sachet presentation The hard capsules for oral use are dispensed in cartons containing 5 or 20 hard capsules, which are individually sealed in sachets.
Għamla tal- qartas Il- kapsuli iebsin għall- użu orali jiġu f; kartun li jkun fihom 5 jew 20 kapsula, li huma issiġillati b’ mod individwali fi qratas.
Marketing Authorization Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l’ Manifattur
SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Il- Belġju
162 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Italia Via fratalli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 21018.1
Centro Direzionale Milano Due Palazzo Borromini I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1
164 PACKAGE LEAFLET:
165 FULJETT TA ’ TAGĦRIF:
Temodal 100 mg hard capsules temozolomide
Temodal 100 mg kapsuli iebsin temozolomide
If you are a newly-diagnosed patient, treatment will occur in two phases:
167 Jekk int pazjent li għadek kif ġejt dijanjostikat, il- kura ser isseħħ f’ żewġ fażijiet:
166 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.
Temodal
168
167 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.
Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
169 komuni ħafna: jeffettwa aktar minn 1 f’ kull 10 li jużawh komuni: jeffettwa minn 1 sa 10 minn kull 100 li jużawh mhux komuni: jeffettwa minn 1 sa 10 minn kull 1, 000 li jużawh rari: jeffettwa minn 1 sa 10 minn kull 10, 000 li jużawh rari ħafna: jeffettwa anqas minn 1 minn kull 10, 000 li jużawh mhux magħruf: frekwenza ma tistax tiġi stmata mid- dejta disponibbli.
168 Very common: loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Nuqqas ta’ l- aptit, uġigħ ta ’ ras, stitikezza (tbati biex tipporga), dardir (tħoss l- istonku mhux f’ postu), rimettar, raxx, jaqa ’ x- xagħar, għeja.
Other side effects:
170 Effetti sekondarji oħrajn:
Each capsule contains 100 mg temozolomide.
Kull kapsula fiha 100 mg temozolomide.
- capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, red iron oxide (E 172),
qoxra tal- kapsula: gelatin, titanium dioxide (E 171), sodium lauril sulfate, red iron oxide (E 172),
Temodal 100 mg hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.
Temodal 100 mg kapsuli iebsin għandhom parti opaka bajda, għatu opak isfar, u huma stampati b’ inka sewda.
Bottle presentation The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
171 Għamla tal- flixkun Il- kapsuli iebsin għall- użu orali jiġu fi fliexken kannella jagħtu fl- oranġjo li jkun fihom 5 jew 20 kapsula.
170 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
172 PACKAGE LEAFLET:
173 FULJETT TA ’ TAGĦRIF:
Temodal 140 mg hard capsules temozolomide
Temodal 140 mg kapsuli iebsin temozolomide
If you are a newly-diagnosed patient, treatment will occur in two phases:
175 Jekk int pazjent li għadek kif ġejt dijanjostikat, il- kura ser isseħħ f’ żewġ fażijiet:
174 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.
Temodal
176
175 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.
Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
177 komuni ħafna: jeffettwa aktar minn 1 f’ kull 10 li jużawh komuni: jeffettwa minn 1 sa 10 minn kull 100 li jużawh mhux komuni: jeffettwa minn 1 sa 10 minn kull 1, 000 li jużawh rari: jeffettwa minn 1 sa 10 minn kull 10, 000 li jużawh rari ħafna: jeffettwa anqas minn 1 minn kull 10, 000 li jużawh mhux magħruf: frekwenza ma tistax tiġi stmata mid- dejta disponibbli.
176 Very common: loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Nuqqas ta’ l- aptit, uġigħ ta ’ ras, stitikezza (tbati biex tipporga), dardir (tħoss l- istonku mhux f’ postu), rimettar, raxx, jaqa ’ x- xagħar, għeja.
Other side effects:
178 Effetti sekondarji oħrajn:
Each capsule contains 140 mg temozolomide.
Kull kapsula fiha 140 mg temozolomide.
- capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, indigo carmine (E 132),
qoxra tal- kapsula: gelatin, titanium dioxide (E 171), sodium lauril sulfate, indigo carmin (E 132).
Temodal 140 mg hard capsules have an opaque white body, a blue cap and and are imprinted with black ink.
Temodal 140 mg kapsuli iebsin għandhom parti opaka bajda, għatu opak ċelesti, u huma stampati b’ inka sewda.
Bottle presentation The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
179 Għamla tal- flixkun Il- kapsuli iebsin għall- użu orali jiġu fi fliexken kannella jagħtu fl- oranġjo li jkun fihom 5 jew 20 kapsula.
178 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
2 ул.
2
180 PACKAGE LEAFLET:
181 FULJETT TA ’ TAGĦRIF:
Temodal 180 mg hard capsules temozolomide
Temodal 180 mg kapsuli iebsin temozolomide
If you are a newly-diagnosed patient, treatment will occur in two phases:
183 Jekk int pazjent li għadek kif ġejt dijanjostikat, il- kura ser isseħħ f’ żewġ fażijiet:
182 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.
Temodal
184
183 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.
Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
185 komuni ħafna: jeffettwa aktar minn 1 f’ kull 10 li jużawh komuni: jeffettwa minn 1 sa 10 minn kull 100 li jużawh mhux komuni: jeffettwa minn 1 sa 10 minn kull 1, 000 li jużawh rari: jeffettwa minn 1 sa 10 minn kull 10, 000 li jużawh rari ħafna: jeffettwa anqas minn 1 minn kull 10, 000 li jużawh mhux magħruf: frekwenza ma tistax tiġi stmata mid- dejta disponibbli.
184 Very common: loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Nuqqas ta’ l- aptit, uġigħ ta ’ ras, stitikezza (tbati biex tipporga), dardir (tħoss l- istonku mhux f’ postu), rimettar, raxx, jaqa ’ x- xagħar, għeja.
Other side effects:
186 Effetti sekondarji oħrajn:
Each capsule contains 180 mg temozolomide.
Kull kapsula fiha 180 mg temozolomide.
- capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172),
qoxra tal- kapsula: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), red iron oxide (E 172).
Temodal 180 mg hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.
Temodal 180 mg kapsuli iebsin għandhom parti opaka bajda, għatu opak oranġjo, u huma stampati b’ inka sewda.
Bottle presentation The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
187 Għamla tal- flixkun Il- kapsuli iebsin għall- użu orali jiġu fi fliexken kannella jagħtu fl- oranġjo li jkun fihom 5 jew 20 kapsula.
SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium 186 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Il- Belġju
188 PACKAGE LEAFLET:
189 FULJETT TA ’ TAGĦRIF:
Temodal 250 mg hard capsules temozolomide
Temodal 250 mg kapsuli iebsin temozolomide
If you are a newly-diagnosed patient, treatment will occur in two phases:
191 Jekk int pazjent li għadek kif ġejt dijanjostikat, il- kura ser isseħħ f’ żewġ fażijiet:
190 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.
Temodal
192
191 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.
Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
193 komuni ħafna: jeffettwa aktar minn 1 f’ kull 10 li jużawh komuni: jeffettwa minn 1 sa 10 minn kull 100 li jużawh mhux komuni: jeffettwa minn 1 sa 10 minn kull 1, 000 li jużawh rari: jeffettwa minn 1 sa 10 minn kull 10, 000 li jużawh rari ħafna: jeffettwa anqas minn 1 minn kull 10, 000 li jużawh mhux magħruf: frekwenza ma tistax tiġi stmata mid- dejta disponibbli.
192 Very common: loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Nuqqas ta’ l- aptit, uġigħ ta ’ ras, stitikezza (tbati biex tipporga), dardir (tħoss l- istonku mhux f’ postu), rimettar, raxx, jaqa ’ x- xagħar, għeja.
Uncommon: flu-like symptoms, red spots under the skin, appearance of a swollen face or muscle weakness, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, difficulty swallowing, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
Mhux komuni: sintomi li jixbhu l- influwenza, dbabar ħomor taħt il- ġilda, il- wiċċ jidher minfuħ jew dgħjufija tal- muskoli, livell baxx ta ’ potassium fid- demm, żieda fil- piż, bidla fil- burdati, alluċinazzjoni u memorja mhux eżatta, paraliżi parzjali, koordinazzjoni mxekkla, diffikulta ’ biex tibla ’, sensazzjonijiet imxekkla, telf parzjali tal- vista, għajnejn xotti jew bl- uġigħ, nuqqas ta ’ smigħ, infezzjoni fil- widna minn ġewwa, tisfir fil- widnejn, uġigħ fil- widnejn, palpitazzjonijiet (meta tista ’ tħoss qalbek tħabbat), demm magħqud fil- pulmun, pressjoni tad- demm għolja, pulmonite, infjammazzjoni fis- sinuses, bronkite, riħ jew influwenza, l- istonku jintefaħ, tbati biex tikkontrolla l - purgar, morliti, ġilda misluħa, żieda fis- sensittività tal- ġilda għad- dawl tax- xemx, bidla fil- kulur tal - ġilda, żieda fl- għaraq, ħsara fil- muskoli, uġigħ fid- dahar, diffikulta ’ biex tgħaddi l- awrina, fsada tal - vaġina, impotenza sesswali, il- perjid ma jiġix jew tara aktar mis- soltu, irritazzjoni tal- vaġina, uġigħ fis- sider, fwawar ta ’ sħana, tertir, telf tal- kulur ta ’ l- ilsien, ma xxommx bħas- soltu, għatx, disturbi tas - snien.
Other side effects:
194 Effetti sekondarji oħrajn:
Each capsule contains 250 mg temozolomide.
Kull kapsula fiha 250 mg temozolomide.
tartaric acid, stearic acid.
kontenut tal- kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
hydroxide and black iron oxide (E 172).
qoxra tal- kapsula: gelatin, titanium dioxide (E 171), sodium lauril sulfate. inka ta ’ l- istampar: shellac, propylene glycol, ilma purifikat, ammonium hydroxide, potassium hydroxide, u black iron oxide (E172).
Temodal 250 mg hard capsules have a opaque white body and cap and are imprinted with black ink.
Temodal 250 mg kapsuli iebsin għandhom iż- żewġ partijiet opaki bojod, u huma stampati b’ inka sewda.
Bottle presentation The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
195 Għamla tal- flixkun Il- kapsuli iebsin għall- użu orali jiġu fi fliexken kannella jagħtu fl- oranġjo li jkun fihom 5 jew 20 kapsula.
194 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
196 PACKAGE LEAFLET:
197 FULJETT TA ’ TAGĦRIF:
Temodal 2.5 mg/ml powder for solution for infusion temozolomide
Temodal 2. 5 mg/ ml trab għal soluzzjoni għall- infużjoni Temozolomide
Before you use Temodal 3.
Qabel ma tuża Temodal 3.
How to use Temodal 4.
Kif għandek tuża Temodal 4.
BEFORE YOU USE TEMODAL
QABEL MA TIEĦU TEMODAL
Do not use Temodal
Tieħux Temodal
- if you have had an allergic reaction to dacarbazine (an anticancer medicine, sometimes called
- jekk kellek reazzjoni allerġika għal dacarbazine (kura kontra l- kanċer, kulltant imsejħa DTIC).
- you should be observed closely for the development of a serious form of chest infection called
- trid tinżamm taħt osservazzjoni stretta għall- iżvilupp ta ’ forma serja ta ’ pulmonite imsejħa
Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
It- tabib tiegħek jista ’ jiddeċiedi li jnaqqas id- doża, iwaqqaf għal ftit jew għal kollox il- kura.
You may also need other treatments.
Jista ’ jkollok bżonn ukoll trattamenti oħrajn.
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 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
- if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
- jekk għandek aktar minn 70 sena, jista ’ jkun li jkollok tendenza akbar li jaqbduk l- infezzjonijiet,
- 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 tista ’ tkun
Important information about some of the ingredients of Temodal This medicinal product contains 2.4 mmol sodium per vial.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Temodal Dan il- prodott mediċinali fih 2. 4 mmol sodium f’ kull kunjett.
This should be taken into consideration by patients on a controlled sodium diet.
Dan għandu jitqies minn pazjenti li jkunu fuq dieta kkontrollata ta ’ sodium.
HOW TO USE TEMODAL
KIF GĦANDEK TUŻA TEMODAL
You may be given other medicines (anti-emetics) to take before and/or after receiving 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 b’ i glijoblastoma multiforme:
If you are a newly-diagnosed patient, treatment will occur in two phases:
Jekk int pazjent li għadek kif ġejt dijanjostikat, il- kura ssir f’ żewġ fażijiet:
- treatment together with radiotherapy (concomitant phase) first
- kura ma ’ radjuterapija (fażi konkomitanti) l- ewwel
- followed by treatment with only Temodal (monotherapy phase).
- segwita minn kura b’ Temodal waħdu (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).
You will receive this dose every day for 42 days (up to 49 days) in combination with radiation therapy.
Ser tieħu din id- doża kuljum għal 42 jum (sa 49 jum) flimkien ma ’ radjuterapija.
The Temodal dose may be delayed or stopped, depending on your 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.
Then, you will start the monotherapy phase.
Dan jagħtik ftit żmien sabiex ġismek jerġa ’ jirkupra.
During the monotherapy phase, the dose and way you receive Temodal in this phase will be different.
199 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.
198 You will receive your new dose of Temodal alone once daily for the first 5 days of each cycle.
Ser tieħu d- doża l- ġdida ta ’ Temodal waħdu għall- ewwel ħamest ijiem (“ ġranet tad- doża ”) ta ’ kull ċiklu.
This adds up to a 28-day treatment cycle.
Dan b’ kollox ikun ċiklu ta ’ kura ta ’ 28 jum.
You will again receive 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.
Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) receiving Temodal only:
Pazjenti b’ tumuri li reġgħu ħarġu jew aggravaw (glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika) li qed jirċievu Temodal biss:
A treatment cycle with Temodal lasts 28 days.
Ċiklu ta ’ kura b’ Temodal jieħu 28 jum.
You will receive Temodal alone once daily for the first 5 days.
Ser tirċievi Temodal waħdu darba kuljum għall- ewel ħamest ijiem.
This adds up to a 28 day treatment cycle.
Dan jammonta għal ċiklu ta ’ kura ta ’ 28 jum.
How Temodal is given Temodal will be given to you by your doctor in a drip into a vein (intervenous infusion), only over approximately 90 minutes.
Kif jingħata Temodal Temodal ser jingħatalek mit- tabib tiegħek fi drip ġo vina (infużjoni għal ġol- vina), fuq perijodu ta ’ madwar 90 minuta.
No infusion site other than a vein is acceptable.
L- ebda sit ta ’ infużjoni m’ hu aċċettabli ħlief vina.
If you use more Temodal than you should Your medicine is given to you by health care professionals.
Jekk tuża Temodal aktar milli suppost Il- mediċina tiegħek ser tingħatalek minn professjonisti fil- kura tas- saħħa.
It is therefore unlikely that you will receive more Temodal than you should.
Għalhekk mhux probabbli li ser tirċievi aktar Temodal milli suppost.
However, if you do, the doctor or nurse will treat you accordingly.
Madankollu, jekk jiġrilek hekk, it- tabib jew infermier tiegħek ser jikkurawk kif jixraq.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta’ dan il- prodott, saqsi lit- tabib jew lill- ispiżjar tiegħek.
- severe headache that does not go away.
- uġigħ ta ’ ras li ma jkunx irid jgħaddi.
This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
Dan jista ’ jikkawżalek żjieda fit- tbenġil jew emorraġġija, anemija (nuqqas ta ’ ċelluli ħomor tad- demm), deni, u tnaqqis fir - 200 reżistenza għall- infezzjonijiet.
The reduction in blood cell counts is usually short-lived.
It- tnaqqis fl- għadd taċ- ċelluli tad- demm normalment ma jdumx.
In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
F’ xi każijiet, jista ’ jieħu fit- tul u jista ’ jwassal għal forma serja ta ’ anemija (anemija aplastika).
199 Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
L- effetti sekondarji jistgħu jseħħu wkoll b’ ċerti frekwenzi, li huma defniti kif ġej: komuni ħafna: jeffettwa aktar minn 1 f’ kull 10 li jużawh komuni: jeffettwa minn 1 sa 10 minn kull 100 li jużawh mhux komuni: jeffettwa minn 1 sa 10 minn kull 1, 000 li jużawh rari: jeffettwa minn 1 sa 10 minn kull 10, 000 li jużawh rari ħafna: jeffettwa anqas minn 1 minn kull 10, 000 li jużawh mhux magħruf: frekwenza ma tistax tiġi stmata mid- dejta disponibbli.
Temodal powder for solution for infusion
Temodal trab għal soluzzjoni għall- infużjoni
In addition to the side effects listed below, the following may also occur with the use of Temodal powder for solution for infusion: pain, irritation, itching, warmth, swelling or redness at the injection site; also bruising (haematoma).
Minbarra l- effetti sekondarji elenkati hawn taħt, dawn l- effetti li ġejjin jistgħu jseħħu jekk qed tieħu Temodal trab għal soluzzjoni għall- infużjoni: uġigħ, irritazzjoni, ħakk, ħruq, nefħa jew ħmura fis- sit mnejn tingħata l- injezzjoni; ukoll tbenġil (ħematoma).
Temodal in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Temodal f’ kurak kombinata ma ’ radjuterapija fi glioblastoma li tkun għadha kif ġiet dijanjostikata
Patients receiving Temodal in combination with radiotherapy may experience different side effects than patients taking Temodal alone.
Pazjenti li qed jirċievu Temodal f’ kombinazzjoni ma ’ radjazzjoni jistgħu jħossu effetti sekondarji differenti minn pazjenti li qed jieħdu Temodal waħdu.
Very common: loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Nuqqas ta’ l- aptit, uġigħ ta ’ ras, stitikezza (tbati biex tipporga), dardir (tħoss l- istonku mhux f’ postu), rimettar, raxx, jaqa ’ x- xagħar, għeja.
Common: oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Komuni: infezzjonijiet fil- ħalq, infezzjoni tal- ferita, tibdil fl- għadd taċ- ċelluli tad- demm (newtropenja, tromboċitopenja, limfopenja, lewkopenja), jogħla z- zokkor fid- demm, titlef il- piż, bidla fl- istat mentali jew viġilanza, ansjetà/ dipressjoni, ngħas, diffikultajiet biex titkellem, l- ekwilibriju jiddgħajjef, sturdament, konfużjoni, tinsa ħafna, tbati biex tikkonċentra, ma tkunx tista ’ torqod jew tibqa rieqed, tingiż, titbenġel, rogħda, vista mhux normali jew imċajpra, tara doppju, problemi fis - smigħ, qtugħ ta ’ nifs, sogħla, demm magħqud fir- riġlejn, jiżdied l- ilma fil- ġisem, nefħa fir- riġlejn, dijarea, uġigħ fl- istonku jew fl- addome, ħruq ta ’ stonku, stonku mqalla, diffikulta ’ biex tibla ’, ħalq xott, irritazzjoni jew ħmura tal- ġilda, ġilda xotta, ħakk, dgħjufija fil- muskoli, uġigħ fil- ġogi, uġigħ fil - muskoli jew weġgħat, tagħmel awrina ta ’ spiss, diffikulta ’ biex iżżomm l- awrina, reazzjoni allerġika, deni, ħsara effett tar- raġġi nefħa fil- wiċċ, uġigħ, togħma anormali, testijiet tal- funzjoni tal- fwied mhux normali.
Temodal monotherapy in recurrent or progressive glioma
Monoterapija b’ Temodal fi glijoma rikurrenti jew progressiva
The following side effects may occur, and may require medical attention.
201 L- effetti mhux mixtieqa li ġejjin jistgħu jseħħu, u jistgħu jeħtieġu attenzjoni medika.
200 Uncommon: reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Mhux komuni: l- għadd taċ- ċelluli tad- demm jonqos (panċitopenja, anemija, lewkopenja).
Rare: cough, infections including pneumonia.
Rari: sogħla, infezzjonijiet inkluża pulmonite.
In very rare cases, patients receiving Temodal and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
F’ każijiet rari ħafna, pazjenti li jieħdu Temodal u mediċini bħalu, jista ’ jkollhom riskju żgħir li jiżviluppaw kanċers sekondarji, li jinkludu l- lewkimja.
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2ºC – 8ºC).
Once your medicine is prepared for infusion (reconstituted), the solution may be stored at room temperature (25°C) for up to 14 hours, including infusion time.
Ladarba l- mediċina tiegħek tkun ippreparata għall- infużjoni (rikostitwit), is- soluzzjoni tista ’ tinħażen f’ temperatura ambjentali (25ºC) sa 14- il siegħa, inkluż il- ħin ta ’ l- infużjoni.
The reconstituted solution should not be used if discolouration or particulate matter is observed.
Is- soluzzjoni rrikostitwita m’ għandhiex tintuża jekk titlef il- kulur jew jidher xi frak.
The active substance is temozolomide.
Is- sustanza attiva hija temozolomide.
Each vial contains 100 mg temozolomide.
Kull kunjett fih 100 mg temozolomide.
After reconstitution, each ml solution for infusion contains 2.5 mg of temozolomide.
Wara li jitħallat, kull ml ta ’ soluzzjoni għall- infużjoni jkun fih 2. 5 mg temozolomide.
The other ingredients are mannitol (E421), threonine, polysorbate 80, sodium citrate (for pH-adjustment) and hydrochloric acid concentrated (for pH-adjustment).
202 Is- sustanzi l- oħrajn huma mannitol (E421), threonine, polysorbate 80, sodium citrate (għall - korrezzjoni tal- pH) u hydrochloric acid konċentrat (għall- korrezzjoni tal- pH).
The powder for solution for infusion is a white powder.
It- trab tas- soluzzjoni għall- infużjoni huwa trab abjad.
Temodal is available in a glass vial, with a butyl rubber stopper and aluminium seal with a flip-off bonnet.
Temodal jiġi f’ kunjett tal- ħġieġ, b’ tapp tal - gomma butyl u siġill ta ’ l- aluminium b’ għatu li jinfetaħ b’ saba.
Each pack contains 1 vial of 100 mg temozolomide.
Kull pakkett fih kunjett 1 ta ’ 100 mg temozolomide.
Marketing Authorization Holder and Manufacturer 201 Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l’ Manifattur
España Km.
203 España Km.