qanastek/EMEA-V3 huggingface dataset:
4 years) who had an unresectable primary tumour or who presented a tumour recurrence or a metastasic disease; most of the children (75%) presented with endocrine symptoms.
8 primarju li ma setax jitneħħa jew li kellhom tumur li reġa ’ tfaċċa jew marda metastatika; il- biċċa l - kbira tat- tfal (75%) kellhom sintomi endokrinali.
Mitotane was given alone or combined with chemotherapy with various agents.
Mitotane ingħata waħdu jew flimkien ma ’ kemoterapija ma ’ diversi prodotti.
Overall, the disease-free interval was 7 months (2 to 16 months).
Globalment, l- intervall mingħajr mard kien ta ’ 7 xhur (2 sa 16- il xahar).
There were recurrences in 40% of children; the survival rate at 5 years was 49%.
Kien hemm 40% tal- każijiet fejn it- tumur fit- tfal reġa ’ tfaċċa; ir- rata ta ’ sopravivenza ta ’ ħames snin kienet ta ’ 49%.
Absorption In a study performed in 8 patients with adrenal carcinoma treated with 2 to 3 g daily of mitotane, a highly significant correlation was found between plasma mitotane concentration and the total mitotane dose.
Assorbiment Fi studju li sar fuq 8 pazjenti b’ karċinoma adrenali li ngħataw 2 sa 3 g kuljum ta ’ mitotane, instabet korrelazzjoni ta ’ sinifikat għoli bejn il- konċentrazzjoni ta ’ mitotane fil- plażma u d- doża totali ta ’ mitotane.
The target plasma mitotane concentration (14 mg/ l) was reached in all patients within 3 to 5 months and the total mitotane dose ranged between 283 and 387 g (median value:
Il- konċentrazzjoni ta ’ mitotane mixtieqa fil- plażma (14 mg/ l) intlaħqet fil- pazjenti kollha fi 3 sa 5 xhur u d- doża totali varjat bejn 283 u 387 g (valur medjan:
The threshold of 20 mg/ l was reached for cumulative amounts of mitotane of approximately 500 g.
Il- limitu ta ’ 20 mg/ l intlaħaq b' ammonti kumulattivi ta ’ mitotane ta ’ bejn wieħed u ieħor 500 g.
In another study, 3 patients with adrenal carcinoma received Lysodren according to a precise protocol allowing fast introduction of a high dose if the product was well tolerated:
Fi studju ieħor, 3 pazjenti b’ karċinoma adrenali ngħataw Lysodren skond protokoll preċiż li jippermetti l- introduzzjoni mgħaġġla ta ’ doża għolja jekk il- prodott ikun ittollerat tajjeb:
3 g (as 3 intakes) on day 1, 4.5 g on day 2, 6 g on day 3, 7.5 g on day 4 and 9 g on day 5.
3 g (bħala 3 dożi) fl- ewwel ġurnata, 4. 5 g fit- tieni ġurnata, 6 g fit- tielet ġurnata, 7. 5 g fir- raba ’ ġurnata u 9 g fil- ħames ġurnata.
This dose of Lysodren was continued or decreased in function of side effects and plasma mitotane levels.
Din id- doża ta ’ Lysodren tkompliet jew tnaqqset skond l- effetti sekondarji u l- livelli ta ’ mitotane fil- plażma.
There was a positive linear correlation between the cumulative dose of Lysodren and the plasma levels of mitotane.
Kien hemm korrelazzjoni lineari pożittiva bejn id- doża kumulattiva ta ’ Lysodren u l- livelli ta ’ mitotane fil - plażma.
In two of the 3 patients, plasma levels of more than 14 mg/ l were achieved within 15 days and in one of them levels above 20 mg/ l were achieved within approximately 30 days.
F’ żewġ pazjenti minn tlieta, livelli fil- plażma ta ’ aktar minn 14 mg/ l intlaħqu fi ħmistax- il ġurnata u f’ wieħed minnhom livelli ogħla minn 20 mg/ l intlaħqu f’ madwar 30 ġurnata.
In addition, in both studies, in some patients, the plasma mitotane levels continued to rise despite maintenance or a decrease of the daily dose of mitotane.
Fiż- żewġ studji, f’ xi pazjenti, il- livelli ta ’ mitotane fil- plażma komplew jogħlew minkejja li nżammet l- istess jew tnaqqset id- doża ta ’ kuljum ta ’ mitotane
7 Distribution Autopsy data from patients show that mitotane is found in most tissues of the body, with fat as the primary site of storage.
Distribuzzjoni L- informazzjoni mill- awtopsji tal- pazjenti turi li mitotane jinstab f’ ħafna mit- tessuti tal- ġisem, bix - xaħam bħala s- sit primarju tal- ħażna.
Metabolism Metabolism studies in man have identified the corresponding acid, 1,1-(o, p'-dichlorodiphenyl) acetic acid (o, p’ -DDA), as the major circulating metabolite, together with smaller quantities of the 1,1-(o, p'- dichlorodiphenyl)-2,2 dichloroethene (o, p’ -DDE) analogue of mitotane.
Metaboliżmu Studji tal- metaboliżmu fil- bniedem identifikaw l- aċidu korrespondenti, 1, 1 - (o, p '- dichlorodiphenyl) acetic acid (o, p ’ - DDA), bħala l- metabolit maġġuri li jiċċirkola, flimkien ma ’ kwantitajiet iżgħar tal - analogu 1, 1 - (o, p' - dichlorodiphenyl) - 2, 2 dichloroethene (o, p ’ - DDE) ta ’ mitotane.
No unchanged mitotane has been found in bile or in urine, where o, p’ -DDA predominates, together with several of its hydroxylated metabolites.
Ma nstabx mitotane mhux mibdul fil- bile jew fl- awrina, fejn l- o, p ’ - DDA tippredomina, flimkien ma ’ diversi metaboliti idrossilati tiegħu.
For induction with cytochrome P450, see section 4.5.
Għal induzzjoni b’ cytochrome P450, ara s- sezzjoni 4. 5.
Excretion After intravenous administration, 25% of the dose was excreted as metabolites within 24 hours.
Tneħħija mill- ġisem Wara li ngħata minn ġol- vina, 25% tad- doża tneħħiet mill- ġisem bħala metaboliti fi żmien 24 siegħa.
Following discontinuation of mitotane treatment, it is slowly released from storage sites in fat, leading to reported terminal plasma half-lives ranging from 18 to 159 days.
Meta titwaqqaf il- kura b' mitotane, jiġi merħi bil- mod mis- siti ta ’ ħażna fix- xaħam, li jwassal għal half - lives terminali li jvarjaw minn 18 sa 159 ġurnata.
Non-clinical data on the general toxicity of mitotane is limited.
Tagħrif mhux- klinikali dwar it- tossiċità ġenerali ta 'mitotane huwa limitat.
Reproductive toxicity studies have not been performed with mitotane.
Ma sarux studji dwar l- effet tossiku ta 'mitotane fuq ir- riproduzzjoni.
However, dichlorodiphenyltrichlorethane (DDT) and other polychlorinated biphenyl analogues are known to have deleterious effects on fertility, pregnancy and development, and mitotane could be expected to share these properties.
Madankollu, dichlorodiphenyltrichlorethane (DDT) u analogi bifenali poliklorinati oħrajn huma magħrufin li għandhom effetti negattivi fuq il- fertilità, tqala u żvilupp, u wieħed jistenna li mitotane jkollu dawn il - karatteristiċi.
The genotoxic and carcinogenic potential of mitotane has not been investigated.
Il- potenzjal ġenotossiku u karċinoġeniku ta ’ mitotane għadu ma ġiex investigat.
Maize starch Microcrystalline cellulose (E 460) Macrogol 3350 Silica colloidal anhydrous
9 Microcrystalline cellulose (E 460) Macrogol 3350 Silica colloidal anhydrous
1 year.
Wara li jinfetaħ: sena.
Square opaque white HDPE bottle containing 100 tablets.
Flixkun HDPE kwadru, abjad u opak li fih 100 pillola.
Pack size of 1 bottle.
Daqs tal- pakkett ta ’ flixkun wieħed.
8 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
This medicinal product should not be handled by persons other than the patient and his/ her caregivers, and especially not by pregnant women.
Dan il- prodott mediċinali m’ għandux jiġi maniġġat minn persuni oħra ħlief il- pazjent u min qed jieħu ħsiebu/ ha u speċjalment mhux minn nisa tqal.
Caregivers should wear disposable gloves when handling the tablets.
Dawk li jieħdu ħsieb il- pazjent għandhom jilbsu ingwanti li jintremew wara li jintmissu l- pilloli.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Laboratoire HRA Pharma 15 rue Béranger 75003 Paris France
Laboratoire HRA Pharma 15 rue Béranger 75003 Paris Franza
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 dan il- prodott mediku hi disponibbli fuq is- sit ta ’ l- internet ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /
9 ANNEX II
10 ANNESS II
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TAL- AWTORIZZAZZJONI GĦAT - B.
10 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
2.800 04010 Sermoneta (Latina) Italy
2. 800 04010 Sermoneta (Latina) L- Italja
B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
Not applicable.
TA ’
11 ANNEX III
L- UŻU
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
TIKKETTA
OUTER CARTON BOTTLE LABEL
KARTUNA TA ’ BARRA TIKKETTA TAL- FLIXKUN
Lysodren 500 mg tablets Mitotane
Lysodren 500 mg pilloli Mitotane
Each tablet contains 500 mg of mitotane.
Kull pillola fiha 500 mg ta ’ mitotane.
Bottle of 100 tablets.
Flixkun ta ’ 100 pillola.
OTHER SPECIAL WARNING (S), IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
Cytotoxic.
Ċitotossiku.
To be handled only by patients, or caregivers wearing gloves.
Għandu jintmiss biss minn pazjenti, jew minn persuni li jagħtu l- kura jekk ikunu liebsin ingwanti.
1 year
Wara li jinfetaħ: sena
NAME AND ADDRESS OF THE MARKETING AUTORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MARKETING AUTORISATION NUMBER
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Lysodren 500 mg tablets Mitotane
Pilloli Lysodren ta ’ 500 mg Mitotane
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek jew lill- ispiżjar tiegħek.
Always keep with you the Lysodren Patient Card included at the end of this leaflet.
Dejjem żomm miegħek il- Kartuna tal- Pazjent Li Qed Jieħu Lysodren li hija nkluża fl- aħħar ta ’ dan il- fuljett.
What Lysodren is and what it is used for 2.
X’ inhu Lysodren u għalxiex jintuża 2.
Before you take Lysodren 3.
Qabel ma tieħu Lysodren 3.
How to take Lysodren 4.
Kif għandek tieħu Lysodren 4.
How to store Lysodren 6.
Kif taħżen Lysodren 6.
WHAT LYSODREN IS AND WHAT IT IS USED FOR
X’ INHU LYSODREN U GĦALXIEX JINTUŻA
Lysodren is an antitumoral medicine.
Lysodren huwa mediċina antitumorali.
This medicine is used for the treatment of symptoms of advanced non operable, metastatic or recurrent malignant tumours of the adrenal glands.
Din il- mediċina tintuża għall- kura tas- sintomi ta ’ tumuri malinni avvanzati li ma jistgħux jitneħħew kirurġikament, metastatiċi jew rikorrenti tal- glandoli adrenali.
BEFORE YOU TAKE LYSODREN
QABEL MA TIEĦU LYSODREN
Do not take Lysodren
Tiħux Lysodren:
- if you are allergic (hypersensitive) to mitotane or any of the other ingredients of Lysodren
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għal mitotane jew għal xi sustanzi oħra ta ’
You must not breast-feed while taking Lysodren.
Lysodren.
- if you are being treated with medicines containing spironolactone (see "Using other
- jekk qiegħda tredda ’.
Take special care with Lysodren You should tell your doctor if any of the following applies to you:
Ma tistax tredda ’ meta tkun qed tieħu Lysodren.
- if you have an injury (shock, severe trauma), an infection or if you have any illness while you
- jekk qed tirċievi kura b’ mediċini li fihom spironolactone (ara “ Meta tuża mediċini oħra ”).
are taking Lysodren.
Oqgħod attent ħafna b’ Lysodren:
Tell your doctor immediately, who may decide to temporarily stop treatment.
Għandek tgħid lit- tabib tiegħek jekk xi punt minn dawn japplika għalik: − jekk għandek korriment (xokk, trawma severa), infezzjoni jew jekk għandek xi marda waqt li qed tieħu Lysodren.
- if you are using any medicines mentioned below (see "Using other medicines").
Għid lit- tabib tiegħek minnufih, u huwa jiddeċiedi għandekx twaqqaf il- kura temporanjament. − jekk tbati minn xi problema severa tal- fwied jew tal- kliewi. − jekk qed tuża xi mediċina msemmija taħt (ara “ Meta tuża mediċini oħra ”).
This medicine should not be handled by persons other than the patient and his/ her caregivers, and especially not by pregnant women.
Din il- mediċina ma għandhiex tintmiss minn persuni għajr il- pazjent u minn dawk li jkunu qegħdin jagħtuh il- kura, b’ mod speċjali ma għandhiex tintmiss minn nisa tqal.
Caregivers should wear disposable gloves when handling the tablets.
Dawk li jipprovdu l- kura għandhom jilbsu ingwanti li jintremew wara l- użu meta jkunu qegħdin imissu l- pilloli.
Your doctor may prescribe you some hormonal treatment (steroids) while you are taking Lysodren.
It- tabib tiegħek jista ’ jagħtik b’ riċetta xi trattament ormonali (sterojdi) waqt li tkun qed tieħu Lysodren.
Always keep with you the Lysodren Patient Card included at the end of this leaflet.
18 Dejjem żomm il- Karta għall- Pazjent ta ’ Lysodren li hija inkluża fit- tmiem ta ’ dan il- fuljett.
17 Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
You must not use Lysodren with medicines containing spironolactone, often used as a diuretic for heart, liver or kidney diseases.
Ma għandekx tuża Lysodren ma ’ mediċini li fihom spironolactone, spiss użat bħala dijuretiku għal mard tal- qalb, fwied jew kliewi.
Lysodren may interfere with several medicines.
Lysodren jista ’ jinterferixxi ma ’ diversi mediċini oħra.
Therefore, you should tell your doctor if you are using medicines containing any of the following active substances:
Għalhekk għandek tgħid lit- tabib tiegħek jekk tkun qed tuża mediċini li fihom xi sustanza attiva minn dawn li ġejjin:
The dose of your
- warfarin jew xi antikoagulant ieħor (sustanzi li jraqqu d- demm), użati biex jimpedixxu l- emboli
anticoagulant may need adjustment.
Id- doża tal- antikoagulant tiegħek jista ’ jkollha bżonn ta ’ aġġustament.
- antiepileptics
- antiepilettiċi
- rifabutin or rifampicin, used to treat tuberculosis
rifabutin jew rifampicin, użati biex jikkuraw it- tuberkolożi
- griseofulvin, used in the treatment of fungal infections
- griseofulvin, użat fil- kura ta ’ infezzjonijiet fungali
- herbal preparations containing St.
- preparazzjonijiet erbali li fihom St.
John’ s wort (Hypericum perforatum)
John’ s wort (Hypericum perforatum)
Taking Lysodren with food and drink Lysodren should preferably be taken during meals containing fat-rich food such as milk, chocolate, oil.
Meta tieħu Lysodren ma ’ l- ikel u max- xorb Preferibbilment, Lysodren għandu jittieħed ma ’ ikliet li jkun fihom ħafna xaħam bħall- ħalib, ċikkulata, żejt.
Pregnancy and breast-feeding Lysodren may harm the foetus.
Tqala u treddigħ Lysodren jista ’ jagħmel ħsara lill- fetu.
If you are pregnant or planning to become pregnant, tell your doctor.
Jekk inti tqila jew qiegħda tippjana li tinqabad tqila, għid lit - tabib tiegħek.
If you may become pregnant, you should use effective contraception during treatment with Lysodren and even after stopping it.
Jekk inti tista ’ tinqabad tqila, għandek tuża kontraċezzjoni effettiva matul il- kura b’ Lysodren u anki wara li tieqaf tieħu din il- kura.
Ask your doctor for advice.
Ħu parir mingħand it- tabib tiegħek.
You must not breast-feed while taking Lysodren and even after stopping it.
Ma għandekx tredda ’ meta tkun qed tieħu Lysodren u anki wara li twaqqfu.
Ask your doctor for advice.
Ħu parir mingħand it - tabib tiegħek.
Driving and using machines Lysodren has a major influence on your ability to drive and use machines.
Sewqan u tħaddim ta ’ magni Lysodren għandu influwenza qawwija fuq l- abbilità tiegħek biex issuq u tħaddem magni.
HOW TO TAKE LYSODREN
KIF GĦANDEK TIEĦU LYSODREN 3.
Always take Lysodren exactly as your doctor has told you.
Dejjem ħu Lysodren eżatt bħal ma jkun qallek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Għandek tiċċekkja mat- tabib jew spiżjar tiegħek jekk m’ intix ċert.
Dose and schedule The usual starting dose for adults is 2 to 3 g (4 to 6 tablets) per day.
Doża u skeda Id- doża normali tal- bidu għall- adulti hija ta ’ 2 sa 3 g (4 sa 6 pilloli) kuljum.
Your doctor may start treatment at higher doses such as 4 to 6 g (8 to 12 tablets).
It- tabib tiegħek jista ’ jibda kura b’ dożi iktar qawwijin bħal 4 sa 6 g (8 sa 12- il pillola)
In order to find the optimal dose for you, your doctor will monitor regularly the levels of Lysodren in your blood.
Sabiex isir jaf liema hija l- aħjar doża għalik. it- tabib tiegħek sejjer jimmonitorja l- livelli ta ’ Lysodren f’ demmek.
Your doctor may decide to stop treatment with Lysodren temporarily or to lower the dose if you experience certain side effects.
It- tabib jista ’ jiddeċiedi li jwaqqaflek il- kura b’ Lysodren temporanjament jew li jnaqqaslek id- doża jekk tħoss xi effetti mhux mixtieqa.
Children and adolescents The starting daily dose of Lysodren is 1.5 to 3.5 g/ m2 body surface (this will be calculated by your doctor according to the weight and the size of the child).
Tfal u adoloxxenti Id- doża tal- bidu ta ’ kuljum ta ’ Lysodren hija 1. 5 sa 3. 5 g/ m2 tal- wiċċ tal- ġisem (dan jiġi kkalkulat mit - tabib tiegħek skond il- piż u d- daqs tat- tifel/ tifla).
The experience in patients in this age group is very limited.
L- esperjenza fil- pazjenti f’ dan il- grupp ta ’ età hija limitata ferm.
Method of administration You should swallow the tablets with water during meals containing fat-rich food.
Għandek tibla ’ l- pilloli mal- ilma matul ikliet li jkun fihom ħafna xaħam.
You can divide the total daily dose in two or three intakes.
Tista ’ taqsam it- teħid tad - doża totali ta ’ kuljum f’ żewġ jew tliet drabi.
If you take more Lysodren than you should
19 Jekk tieħu Lysodren aktar milli suppost:
18 Tell your doctor immediately if you have taken accidentally more Lysodren than you should or if a child has accidentally swallowed some.
Għid lit- tabib tiegħek minnufih jekk aċċidentalment tieħu aktar Lysodren milli suppost jew jekk xi ħadd mit- tfal bela ’ xi ftit aċċidentalment.
If you forget to take Lysodren If you accidentally miss a dose, just take the next dose as scheduled.
Jekk aċċidentalment insejt tieħu doża, ħu d- doża skedata li jmiss.
Do not take a double dose to make up for the forgotten one.
M’ għandekx tieħu doża doppja biex tpatti għal dik li tkun insejt tieħu.
Like all medicines, Lysodren can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Lysodren jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor immediately if you experience any of the following side effects:
Għid lit- tabib tiegħek minnufih jekk tesperjenza xi wieħed mill- effetti sekondarji li ġejjin:
- Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhoea, confusion
- Insuffiċienza adrenali: għeja kbira, uġigħ addominali, nawsja, remettar, dijarea, konfużjoni
- Anaemia: cutaneous pallor, muscular fatigability, feeling breathless, vertigo especially when
- Anemija: sfurija kutanja, għeja muskolari, disturbi fi- nifs, vertigo speċjalment meta tqum bil -
standing up
wieqfa
- Liver damage: yellowing of the skin and eyes, itching, nausea, diarrhoea, fatigue, dark coloured
- Indeboliment fil- fwied: sfurija tal- ġilda u l- għajnejn, ħakk, nawsja, dijarea, għeja kbira, awrina
urine
skura
- Neurological disorders: movement and coordination disorders, abnormal sensations like pins
- Disturbi newroloġiċi: disturbi fil- moviment u fil- koordinazzjoni, sensazzjonijiet anormali bħal
and needles, memory loss, concentration difficulty, difficulty to talk, vertigo
meta jorqdulek partijiet minn ġismek, telf ta ’ memorja, diffikultà fil- konċentrazzjoni, diffikultà biex titkellem, vertigo
These symptoms may reveal complications for which specific medication could be appropriate.
Dawn is- sintomi jistgħu jikxfu kumplikazzjonijiet li għalihom tista tkun xierqa medikazzjoni speċifika.
Side effects may occur with certain frequencies, which are defined as follows:
Effetti sekondarji li jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġejjin:
- very common: affects more than 1 user in 10
- komuni ħafna: taffettwa aktar minn utent 1 minn kull 10
- common: affects 1 to 10 users in 100
- komuni: taffettwa utent 1 sa 10 minn kull 100
- uncommon: affects 1 to 10 users in 1,000
- mhux komuni: taffettwa utent 1 sa 10 minn kull 1, 000
- rare: affects 1 to 10 users in 10,000
- rari: taffettwa utent 1 sa 10 minn kull 10, 000
- very rare: affects less than 1 user in 10,000
- rari ħafna: taffettwa inqas minn utent 1 minn kull 10, 000
- not known: frequency cannot be estimated from the available data
- mhux magħrufa: il- frekwenza ma tistax tiġi stmata mid- dejta disponibbli
Very common side effects
Effetti sekondarji komuni ħafna
- vomiting, nausea (feeling sick), diarrhoea, belly pain
- rimettar, nawsja (tħossok ma tiflaħx), dijarrea, uġigħ ta ’ żaqq
- lack of appetite
- nuqqas ta ’ aptit
- abnormal sensations like pins and needles
- sensazzjonijiet anormali bħal meta jorqdulek partijiet minn ġismek
- movement and coordination disorders, vertigo, confusion
- disturbi fil- moviment u fil- koordinazzjoni, vertigo, konfużjoni
- feeling sleepy, fatigue, muscle weakness (fatigue of muscle during effort)
- ħedla, għeja, dgħjufija fil- muskoli (għeja tal- muskoli matul sforz)
- inflammation (swelling, heat, pain) of mucosa, skin rash
- infjammazzjoni (nefħa, sħana, uġigħ) tal- mukoża, raxx tal- ġilda
- blood disorders (bleeding time prolonged)
- disturbi fid- demm (titwil tal- ħin ta ’ fsada)
- increase of cholesterol, triglycerides (fats) and liver enzymes (in blood tests)
- żieda fil- kolesterol, trigliċeridi (xaħmijiet) u enzimi tal- fwied (f’ testijiet tad- demm)
- decrease in white blood cells count
- tnaqqis fl- għadd taċ- ċelloli tad- demm bojod
- breast overdevelopment in men
- żvilupp żejjed tas- sider fl- irġiel
- adrenal insufficiency
- insuffiċjenza adrenali
- dizziness, headache
- sturdament, uġigħ ta ’ ras
- peripheral nervous system disorders: association of sensory disorders, muscular weakness and
- disturbi periferali fis- sistema nervuża: assoċjazzjoni ta ’ disturbi sensorji, dgħjufija muskolari u
atrophy, decrease of tendon reflex and vasomotor symptoms such as hot flushes, sweat and sleep disorders)
atrofija, tnaqqis fir- riflessi tat- tendini u sintomi vażomotorili bħal fwawar sħan, għaraq u disturbi waqt l- irqad)
- mental impairment (such as memory loss, concentration difficulty)
- indeboliment mentali (bħal telfien fil- memorja, diffikultà fil- konċentrazzjoni)
- movement disorder
- disturbi fil- movimenti
- decrease of red blood cells (anaemia, with symptoms such as skin pallor and fatigue), decrease
- tnaqqis fiċ- ċelloli l- ħomor tad- demm (anemija, b’ sintomi bħalma huma sfurija tal- ġilda u
in blood platelets (may make you more prone to bruising and bleeding)
għeja), tnaqqis fil- plejtlits tad- demm (jistgħu jagħmluk aktar suxxettibbli għal tbenġil u fsada)
- hepatitis (auto-immune) (may cause yellowing of the skin and eyes, dark coloured urine)
- epatite (awto- immuni) (tista ’ tikkawża sfurija tal- ġilda u tal- għajnejn, awrina kulur skur)
19 Frequency Not Known
Frekwenza Mhux Magħrufa
- general aching
- uġigħ ġenerali
- flushing, high or low blood pressure, feeling of dizziness/ vertigo when you suddenly stand up
- fwawar, pressjoni tad- demm għolja jew baxxa, tħossok stordut/ vertigo meta tqum bil- wieqfa
- increased production of saliva
- żieda fil- produzzjoni tal- bżieq
- eye disorders: visual impairment, vision blurred, double vision
- disturbi fl- għajnejn: indeboliment fil- viżta, viżta mċajpra, viżta doppja
- fungal infection
- infezzjoni fungali
- liver damage (may cause yellowing of the skin and eyes, dark coloured urine)
- ħsara fil- fwied (tista ’ tikkawża sfurija tal- ġilda u tal- għajnejn, awrina kulur skur)
- decreased uric acid in blood tests
- livelli iktar baxxi ta ’ aċidu uriku f’ testijiet tad- demm
- bladder inflammation with bleeding
- infjammazzjoni tal- bużżieqa tal- awrina b’ demm
- presence of blood in urine, presence of proteins in urine,
- preżenza ta ’ demm fl- awrina, preżenza ta ’ proteini fl- awrina,
In children and adolescents, thyroid problems, neuro-psychological and growth retardation have been observed.
Fi tfal u adoloxxenti, ġew osservati problemi fit- tirojde, nuqqas ta ’ avvanz newro- psikoloġiku u nuqqas ta ’ żvilupp fid- daqs.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or your pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE LYSODREN
KIF TAĦŻEN LYSODREN
Do not use after the expiry date which is stated on the carton and the bottle after EXP.
M’ għandekx tużah wara d- data ta ’ skadenza li tidher fuq il- kartuna u/ jew fuq il- flixkun wara JIS.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.
Kull prodott jew materjal mhux użat għandu jintrema skont ir- rekwiżiti lokali għal mediċini ċitotossiċi.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tar- rimi jew maż- żibel tad- dar.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar tiegħek kif għandhom jintremew l- mediċini, kontenituri mhux użati jew fliexken parzjalment vojta li mhux aktar meħtieġa.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu biex jipproteġu l- ambjent.
What Lysodren contains
X’ fih Lysodren
- The active substance is mitotane.
- Is- sustanza attiva hi Mitotane.
- The other ingredients are maize starch, microcrystalline cellulose (E 460), macrogol 3350 and
- Is- sustanzi l- oħrajn huma lamtu tal- qamħirrun, microcrystalline cellulose (E 460), macrogol 3350
silica colloidal anhydrous.
u silica colloidal anhydrous..
What Lysodren looks like and contents of the pack Lysodren tablets are white, biconvex, round and scored.
Id- dehra ta ’ Lysodren u l- kontenuti tal- pakkett Il- pilloli Lysodren huma bojod, ibbuzzati fuq iż- żewġ naħat, tondi u b’ linja mnaqqxa fuqhom.
Lysodren is available in plastic bottles of 100 tablets.
Lysodren jiġi fi fliexken tal- plastik ta ’ 100 pillola.
Marketing Authorisation Holder Laboratoire HRA Pharma 15 rue Béranger F - 75003 Paris France
Laboratoire HRA Pharma 15 rue Béranger F - 75003 Paris Franza
Manufacturer Bristol-Myers Squibb S. p. A.
Manifattur:
Via del Murillo Km.
21 Bristol- Myers Squibb S. p. A., Via del Murillo Km.
2.800 I - 04010 Sermoneta (LT) Italy
2. 800 I - 04010 Sermoneta (LT) L- Italja
20 For any information about this medicine, please contact the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
LYSODREN PAT IENT CARD
IL- KARTUNA TAL- PAZJENT LI QED JIEĦU LYSODREN
I am on Lysodren (mitotane) treatment
Jiena qed nirċievi kura b’ Lysodren (mitotane)
The name of my Doctor is:
………………………………………..
………………………………………..
Tel: ……..... ………………………….
prone to acute adrenal insufficiency
Jista ’ jaqbadni insuffiċjenza adrenali akuta
Laboratoire HRA Pharma Tel: + 33 1 40 33 11 30
Għal informazzjoni dwar il- prodott, F’ każ ta ’ emerġenza, jekk jogħġbok ikkuntattja lil: għandhom jittieħdu miżuri Laboratoire HRA Pharma adegwati ta ’ prekawzjoni Tel: + 33 1 40 33 11 30 lysodren@ hra- pharma. com
What is MabCampath?
X’ inhu MabCampath?
MabCampath is a concentrate that is made up into a solution for infusion (drip into a vein).
MabCampath huwa konċentrat li jitħallat f’ soluzzjoni għall- infużjoni (drip ġol- vina).
It contains the active substance alemtuzumab (10 mg/ ml or 30 mg/ ml).
Fih is- sustanza attiva alemtuzumab (10 mg/ ml jew 30 mg/ ml).
What is MabCampath used for?
Għalfejn jintuża MabCampath?
MabCampath is an anticancer medicine.
MabCampath huwa mediċina kontra l- kanċer.
It is used to treat patients with chronic lymphocytic leukaemia (CLL), a cancer of the lymphocytes (a type of white blood cell).
Jintuża biex jittratta l- pazjenti b’ lewċemija linfoċitika kronika (CLL), kanċer tal- linfoċiti (tip ta ’ ċellola bajda tad- demm).
MabCampath is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.
MabCampath jintuża f’ pazjenti li għalihom, kombinazzjonijiet ta ’ trattament inklużi fludarabine (mediċina oħra użata fil- lewċemija) mhumiex adatti.
How is MabCampath used?
Kif jintuża MabCampath?
MabCampath treatment should be supervised by a doctor experienced in the use of cancer treatments.
It- trattament MabCampath għandu jkun sorveljat minn tabib b’ esperjenza fit- terapija onkoloġika.
Patients should be given steroids, an antihistamine and a painkiller before the first dose and before any increase in dose.
Il - pazjenti għandhom jingħataw sterojdi, antistamina u mediċina kontra l- uġigħ qabel l- ewwel doża u qabel kwalunkwe żieda fid- doża.
They should also receive antibiotics and antiviral medicines during and after treatment.
Għandhom jingħataw ukoll antibijotiċi u mediċini antivirali waqt u wara t- trattament.
MabCampath is given as an infusion lasting about two hours.
MabCampath jingħata b’ infużjoni li ddum madwar sagħtejn.
During the first week of treatment, MabCampath should be given in increasing doses:
Waqt l- ewwel ġimgħa ta ’ trattament, MabCampath għandu jingħata f’ dożi li jiżdiedu:
3 mg on day 1, 10 mg on day 2 and 30 mg on day 3, as long as each dose is well tolerated.
3 mg f’ jum nru 1, 10 mg f’ jum nru 2 u 30 mg f’ jum nru 3, sakemm kull doża tkun tollerata sewwa.
This is called ‘ dose escalation’.
Din tissejjaħ ‘ eskalazzjoni tad- doża ’.
After this, the recommended dose is 30 mg a day, given three times a week (every other day) for a maximum of 12 weeks.
Wara dan, id- doża rakkomandata hija 30 mg kuljum, mogħtija tliet darbiet fil- ġimgħa (jum iva u jum le) għal massimu ta ’ 12- il ġimgħa.
Patients should be monitored during treatment to see how they respond, but also to check their blood levels of platelets (the components that help clotting) and neutrophils (the white blood cells that fight infection): if these are too low the treatment should be interrupted or stopped.
Il- pazjenti għandhom ikunu sorveljati waqt it- trattament biex jiġi osservat kif jirreaġixxu, iżda wkoll biex jiġi kkontrollat il- livell ta ’ platelets f’ demmhom (il- komponenti li jgħinu lid- demm jagħqad) u newtrofili (iċ- ċelloli bojod li jiġġieldu l- infezzjoni): jekk dawn ikunu baxxi wisq, it- trattament għandu jiġi sospiż jew imwaqqaf.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Għal dettalji sħaħ, ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
How does MabCampath work?
Kif jaħdem MabCampath?
The active substance in MabCampath, alemtuzumab, is a monoclonal antibody.
Is- sustanza attiva f’ MabCampath, alemtuzumab, hija antikorp monoklonali.
In CLL, too many lymphocytes are produced.
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li tfassal biex jagħraf u jorbot ma ’ struttura speċifika (imsejħa antiġene) li tinsab f’ ċerti ċelloli tal- ġisem. F’ CLL, il- produzzjoni ta ’ linfoċiti hija żżejjed.
Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with
Alemtuzumab tfassal biex jorbot ma ’ glikoproteina (proteina miksija b’ molekuli taz- zokkor) li
Reproduction is authorised provided the source is acknowledged. sugar molecules) called CD52 that is found on the surface of lymphocytes.
© European Medicines Agency, 2008 Reproduction is authorised provided the source is acknowledged tissejjaħ CD52 li tinsab fil- wiċċ taċ- ċelloli.
As a result of this binding, the lymphocytes die, and this helps to control the CLL.
B’ riżultat ta ’ dan l- irbit, il- linfoċiti jmutu, u dan jgħin biex jikkontrolla s- CLL.
How has MabCampath been studied?
Kif ġie studjat MabCampath?
MabCampath has been examined in four main studies involving a total of 446 patients with CLL.
MabCampath ġie eżaminat f’ erba ’ studji ewlenin li involvew total ta ’ 446 pazjent.
One study included 297 patients who had not received treatment before.
Studju inkluda 297 pazjent li ma kinux irċievew trattament qabel.
It compared the effectiveness of a 12-week course of MabCampath with that of a year-long course of chlorambucil (another anticancer medicine).
Huwa qabbel l- effikaċja ta ’ kors ta ’ 12- il ġimgħa ta ’ MabCampath ma ’ dik ta ’ kors ta ’ sena sħiħa ta ’ chlorambucil (mediċina oħra kontra l- kanċer).
The main measure of effectiveness was how long it took until the disease got worse or the patient died.
Il - miżura ewlenija ta ’ l- effikaċja kienet kemm ittieħed żmien sakemm il- marda marret għall- agħar jew miet il- pazjent.
The other three studies looked at a total of 149 patients who had already received other treatments.
It- tliet studji l- oħra ħarsu lejn total ta ’ 149 pazjent li kienu diġà rċevew trattamenti oħrajn.
In these studies, MabCampath was not compared with any other treatment.
F’ dawn l - istudji, MabCampath ma tqabbilx ma ’ trattament ieħor.
The main study included 93 patients in whom previous treatment with fludarabine had stopped working.
L- istudju ewlieni inkluda 93 pazjent li fuqhom, it- trattament bi fludarabine kien waqaf jaħdem.
The main measure of effectiveness was the overall response to treatment.
Il- kejl ewlieni ta ’ l- effikaċja kien ir- reazzjoni totali għal kura.
What benefit has MabCampath shown during the studies?
X’ benefiċċju wera MabCampath waqt l- istudji?
In patients who had not received treatment before, MabCampath was more effective than chlorambucil.
F’ pazjenti li ma kinux irċevew trattament qabel, MabCampath kien aktar effikaċi minn chlorambucil.
In the patients receiving MabCampath, it took an average of 14.6 months for the disease to get worse or for the patient to die, compared with 11.7 months in those taking chlorambucil.
F’ pazjenti li kienu qegħdin jirċievu MabCampath, kellhom jgħaddu madwar 14. 6 – il xahar sakem ma l- marda kienet marret għall- agħar jew biex il- pazjent imut, meta mqabbel ma ’ 11. 7- il xahar għal dawk li kienu qegħdin jieħdu chlorambucil.
In the main study of patients who had been treated before, 33% responded partially or completely to treatment with MabCampath.
Fl- istudju ewlieni ta ’ pazjenti li kienu ttrattati qabel, 33% rreaġixxew parzjalment jew kompletament għal kura b’ MabCampath.
Similar results were seen in the other two studies of previously treated patients.
Riżultati simili dehru fiż- żewġ studji l- oħrajn ta ’ pazjenti diġà ttrattati.
What is the risk associated with MabCampath?
X’ inhu r- riskju assoċjat ma ’ MabCampath?
Side effects occur in about 97% of patients who have not been treated before and about 80% of those who have previously received treatment.
Iseħħu effetti sekondarji f’ madwar 97% tal- pazjenti li ma kinux ittrattati qabel u madwar 80% ta ’ dawk li qabel irċevew il- kura.
The most common side effects (seen in more than 1 patient in 10) are infections, hypotension (low blood pressure), nausea (feeling sick), urticaria (hives), rash, fever, chills, low counts of blood cells (granulocytes, platelets and red blood cells), anorexia (loss of appetite), headache, dyspnoea (breathlessness), vomiting, diarrhoea, pruritus (itching), hyperhidrosis (excessive sweating) and fatigue (tiredness).
L- aktar effetti sekondarji komuni (dehru f’ pazjent 1 minn kull 10) huma infezzjonijiet, ipotensjoni (pressjoni tad- demm baxxa), nawżea (dardir), urtikarja (ħorriqija), raxx, deni, tertir, għadd baxx ta ’ ċelloli tad- demm (granuloċiti, platelets u ċelloli ħomor tad- demm), anoressija (telf ta ’ aptit), uġigħ ta ’ ras, dispnea (qtugħ ta ’ nifs), remettar, dijarea, prurite (ħakk), iperidrożi (ħruġ eċċessiv ta ’ għaraq) u għeja kbira.
For the full list of all side effects reported with MabCampath, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rapportati b’ MabCampath, ara l- Fuljett ta ’ Tagħrif.
MabCampath should not be used in people who may be hypersensitive (allergic) to alemtuzumab, mouse proteins, or any of the other ingredients.
MabCampath m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal alemtuzumab, proteini tal- ġurdien, jew għal kwalunkwe sustanza attiva oħra.
MabCampath must not be used in patients: • who have an active infection that has spread throughout the body; • with HIV infection; • who have active, secondary cancers; • who are pregnant.
MabCampath m’ għandux jintuża ukoll f’ pazjenti: • li għandhom infezzjoni attiva li nfirxet ġewwa l- ġisem; • b’ infezzjoni HIV; • li għandhom kanċers sekondarji attivi; • li huma tqal.
Why has MabCampath been approved?
Għaliex ġie approvat MabCampath?
The Committee for Medicinal Products for Human Use (CHMP) noted that the effectiveness of MabCampath had been demonstrated, but that there is no information from studies directly comparing MabCampath with treatment combinations including fludarabine, which are widely used to treat patients with CLL.
Il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) innota li l- effikaċja ta ’ MabCampath ntweriet, iżda ma hemm l- ebda tagħrif minn studji li jqabblu MabCampath direttament ma ’ kombinazzjonijiet ta ’ trattament inkluż fludarabine, li huma użati bil- bosta biex jittrattaw pazjenti b’ CLL.
Therefore, the Committee concluded that MabCampath’ s benefits are greater than its risks for the treatment of patients with B-cell CLL for whom fludarabine combination chemotherapy is not appropriate.
Għaldaqstant, il- Kumitat ikkonkluda li l- benefiċċji ta ’ MabCampath huma akbar mir- riskji tiegħu għal trattament ta ’ pazjenti b’ CLL ċellola- B għal liema, kemjoterapija ta ’ kombinazzjoni b’ fludarabine mhijiex adatta.
The Committee recommended that MabCampath be given marketing authorisation.
Il- Kumitat irrakkomanda li MabCampath jingħata awtorizzazzjoni għat - tqegħid fis- suq.
MabCampath was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, it had not been possible to obtain complete information on the medicine.
MabCampath ġie awtorizzat oriġinarjament taħt ‘ Ċirkostanzi ta ’ Eċċezzjoni ’, minħabba li, għal raġunijiet xjentifiċi, ma kienx possibbli li jinkiseb tagħrif sħiħ dwar il- mediċina.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 04 July 2008.
Peress li l- kumpanija kienet ipprovdiet it- tagħrif addizzjonali mitlub, iċ - ‘ Ċirkostanzi ta ’ Eċċezzjoni ’ intemmu f’ 04 ta ’ Lulju 2008.
Which measures are being taken to ensure the safe use of MabCampath?
X’ miżuri qegħdin jittieħdu biex jassiguraw l- użu sikur ta ’ MabCampath?
The company that makes MabCampath will provide a brochure containing information on the medicine ’ s safety to all doctors in all Member States who prescribe the medicine.
Il- kumpanija li tagħmel MabCampath sejra tipprovdi fuljett li fih tagħrif fuq is- sigurtà tal- mediċina lit - tobba kollha fl- Istati Membri kollha li jiktbu b’ riċetta il- mediċina.
2/ 3 Other information about MabCampath:
2/ 3 Tagħrif ieħor dwar MabCampath:
The European Commission granted a marketing authorisation valid throughout the European Union for MabCampath on 6 July 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal MabCampath fis- 6 ta ’ Lulju 2001.
The marketing authorisation was renewed on 6 July 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 6 ta ’ Lulju 2006.
The marketing authorisation holder is Genzyme Europe BV.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa Genzyme Europe BV.
The full EPAR for MabCampath is available here.
L- EPAR sħiħ għal MabCampath jista ’ jiġi kkonsultat hawn.
FOR USE OF THE MEMBER STATES
GĦALL- UŻU MILL- ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI
The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product as described below are implemented:
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir - rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali kif deskritti hawn isfel jiġu implimentati.
- To agree the details of an educational brochure with the MAH.
Sabiex jiġu miftehma d- dettalji ta ’ fuljett edukattiv ma ’ l- MAH
The Member States shall ensure that the MAH provides all doctors who are expected to prescribe MabCampath with a healthcare professional information pack containing the following: • Educational brochure • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
L- Istati Membri għandhom jiżguraw li l- MAH jipprovdi lit- tobba kollha li huma mistennija li jiktbu MabCampath li dawn jingħataw pakkett ta ’ l- informazzjoni għal professjonisti tal- kura tas- saħħa li jkun jikkonsisti minn: • Fuljett edukattiv • Sommarju tal- Karatteristiċi tal- Prodott (SKP), Fuljett ta ’ l- Informazzjoni u Tikkettar
Key elements to be included in the educational brochure
Elementi ewlenin li jridu jiġu inklużi fil- fuljett edukattiv
• The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following MabCampath therapy • The risk of infusion reactions o Need for premedication o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
• Ir- riskju għal infezzjonijiet opportunistiċi, b’ mod partikolari CMV viraemia • Rakkomandazzjoni li ma jingħatawx vaċċinazzjonijiet b’ vaċċini ħajjin għal ta ’ lanqas 12- il xahar wara t- terapija b’ MabCampath • Ir- riskju ta ’ reazzjonijiet ta ’ infużjoni o Il- bżonn li tingħata mediċina minn qabel o Li trattament għal reazzjonijiet ta ’ sensittività eċċessiva, li jinkludu miżuri ta ’ risuxxitazzjoni għandhom ikunu disponibbli waqt l- għoti o Li l- ogħla riskju ta ’ reazzjonijiet ta ’ l- infużjoni huma fl- ewwel ġimgħa ta ’ terapija o Li jekk ir- reazzjoni hija moderata jew qawwija, id- doża għandha tibqa ’ fl- istess livell (ie. id- doża m’ għandiex togħla) sakemm kull doża tkun ittollerata sew o Jekk ma tingħatax terapija għal aktar minn 7 ijiem allura MabCampath għandu jerġa ’ jibda jingħata b’ doża gradwali dejjem togħla
MabCampath 10 mg/ ml concentrate for solution for infusion
MabCampath 10 mg/ ml konċentrat għal soluzzjoni għall- infużjoni
One ml contains 10 mg of alemtuzumab.
1ml fih 10 mg ta ’ Alemtuzumab.
Each ampoule contains 30 mg of alemtuzumab.
Kull ampulla fiha 30 mg ta ’ alemtuzumab.
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52).
Alemtuzumab huwa antikorp monoklonali umanizzat tat- tip IgG1 kappa magħmul permezz ta ’ inġinerija ġenetika, speċifiku għal glycoprotein (CD52) tal- wiċċ taċ- ċellula limfoċita tat- tip 21- 28 kD.
The antibody is produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.
L- antikorp huwa prodott f’ koltura f’ suspensjoni ta ’ ċelluli mammiferi (Ovarju tal- Ħamster Ċiniż) f’ sustanza nutrittiva.
For a full list of excipients, see section 6.1.
Għal- lista kompleta sustanzi mhux attivi, ara sezzjoni 6. 1.
Colourless to slightly yellow concentrate.
Konċentrat bla kulur sa kemmxejn isfar.
MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B- CLL) for whom fludarabine combination chemotherapy is not appropriate.
MabCampath huwa indikat għall- kura ta ’ pazjenti b’ lewkimja limfoċitika kronika taċ- ċellula B (B - CLL) li għalihom kimoterapija kombinata ta ’ fludarabine mhix xierqa.
MabCampath should be administered under the supervision of a physician experienced in the use of cancer therapy.
MabCampath għandu jiġi mogħti taħt is- sorveljanza ta ’ tabib b’ esperjenza fl- użu ta ’ terapija għall - kanċer.
The MabCampath solution must be prepared according to the instructions provided in section 6.6.
Is- soluzzjoni MabCampath għandha tiġi preparata skond l- istruzzjonijiet ipprovduti f’ sezzjoni 6. 6.
All doses should be administered by intravenous infusion over approximately 2 hours.
Id - dożi kollha għandhom jiġu amministrati permezz ta ’ infużjoni fil- vini fuq medda ta ’ madwar sagħtejn.
Patients should be premedicated with oral or intravenous steroids, an appropriate antihistamine and analgesic 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated thereafter (see section 4.4).
Il- pazjenti għandhom jiġu kkurati minn qabel bi sterojdi orali jew fil- vini, antistamina u analġeżiku xierqa li jingħataw 30- 60 minuta qabel l- għoti ta ’ kull infużjoni ta ’ MabCampath waqt l- għoti ta ’ dożi aktar qawwija u wara dan kif indikat b’ mod kliniku (ara sezzjoni 4. 4).
Antibiotics and antivirals should be administered routinely to all patients throughout and following treatment (see section 4.4).
Anti- bijotiċi u antivirali għandhom jingħataw lill- pazjenti kollha bħala rutina matul u wara l- kura (ara sezzjoni 4. 4).
During the first week of treatment, MabCampath should be administered in escalating doses:
Matul l- ewwel ġimgħa ta ’ kura, MabCampath għandu jingħata f’ dożi dejjem aktar qawwija:
3 mg on day 1, 10 mg on day 2 and 30 mg on day 3 assuming that each dose is well tolerated.
3 mg fl - ewwel jum, 10 mg fit- tieni jum u 30 mg fit- tielet jum 3 dejjem jekk kull doża hija ittollerata tajjeb.
Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of 12 weeks.
Minn hemm `il quddiem, id- doża rrakkomandata hija ta ’ 30 mg kuljum, li tingħata tliet darbiet fil - ġimgħa, ġurnata iva, ġurnata le għal massimu ta ’ 12- il ġimgħa.
In most patients, dose escalation to 30 mg can be accomplished in 3-7 days.
Fil- biċċa l- kbira tal- pazjenti, iż- żjieda fid- doża għal 30 mg tista 'tintlaħaq fi żmien 3- 7 ijiem.
However, if acute moderate to severe adverse reactions such as hypotension, rigors, fever, shortness of breath, chills, rashes and bronchospasm (some of which may be due to cytokine release) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated before further dose escalation is attempted (see section 4.4).
Madankollu, jekk isseħħu reazzjonijiet avversi akuti ta ’ natura moderata sa severa bħal pressjoni baxxa, tertir, deni, qtugħ ta ’ nifs, sirdat, raxx u bronkospażmu (li wħud minnhom jistgħu jkunu minħabba reħa ta ’ cytokine) fil- livell ta ’ dożaġġ ta ’ 3 mg jew ta ’ 10 mg, dawk id- dożi għandhom jiġu ripetuti kuljum sakemm ikunu ittollerati sew qabel ma tiġi ppruvata doża ogħla (ara sezzjoni 4. 4).
2 Median duration of treatment was 11.7 weeks for first-line patients and 9.0 weeks for previously treated patients.
2 Iż- żmien medjan ta ’ kura kien ta ’ 11. 7 ġimgħat għal pazjenti li għalihom din kienet il- kura preferita u 9. 0 ġimgħat għal pazjenti kkurati qabel.
Once a patient meets all laboratory and clinical criteria for a complete response, MabCampath should be discontinued and the patient monitored.
La darba pazjent jissodisfa l- kriterji kliniċi u tal- laboratorju kollha għal rispons sħiħ, MabCampath għandu jitwaqqaf u l- pazjent jiġi sorveljat.
If a patient improves (i. e. achieves a partial response or stable disease) and then reaches a plateau without further improvement for 4 weeks or more, then MabCampath should be discontinued and the patient monitored.
Jekk pazjent jitjib (i. e. jilħaq rispons parzjali jew marda stabbli) u mbagħad jilħaq stat stabbli mingħajr aktar titjib għal 4 ġimgħat jew aktar, MabCampath għandu jitwaqqaf u l- pazjent jiġi sorveljat.