qanastek/EMEA-V3 huggingface dataset:
During the first week, 3 mg of MabCampath in the solution is given on Day 1, then 10 mg on Day 2 and then 30 mg on Day 3.
Matul l- ewwel ġimgħa, 3 mg ta ’ MabCampath f’ soluzzjoni jiġu mogħtija f' Jum 1, imbagħad 10 mg f' Jum 2 u mbagħad 30 mg f' Jum 3.
MabCampath will continue to be given at 30 mg on each of 3 alternate days each week.
30 mg ta ’ MabCampath tibqa ’ tingħata 3 darbiet fil- ġimgħa, ġurnata iva u ġurnata le.
Your doctor will increase the dose of MabCampath slowly to reduce the possibility of you having side effects and to allow your body to tolerate MabCampath better.
It- tabib tiegħek se jżid id- doża ta ’ MabCampath bil- mod biex inaqqas il - possibbiltà li int ikollok effetti sekondarji u biex jippermetti lill- ġisem tiegħek jittollera lil MabCampath aħjar.
If you experience early side effects the initial smaller doses may be repeated until the effects go away or reduce.
Jekk ikollok effetti sekondarji bikrija, id- dożi ż- żgħar tal- bidu jistgħu jibqgħu jiġu ripetuti sakemm l - effetti jgħaddu jew jonqsu.
The doctor will carefully monitor you and decide what are the appropriate amounts of MabCampath to give during your whole treatment period.
It- tabib se jissorveljak b’ attenzjoni u jiddeċiedi x’ inhuma l- ammonti xierqa ta ’ MabCampath li għandhom jingħataw waqt il- perjodu ta ’ kura.
MabCampath treatment may continue for up to 12 weeks depending on your progress.
Kura b’ MabCampath tista ’ tissokta sa 12- il ġimgħa skond il- progress tiegħek.
If more MabCampath is given than recommended
Jekk jingħata aktar MabCampath milli suppost
Your doctor will treat you, as appropriate, if you have any side effects.
Jekk ikollok xi effetti sekondarji t- tabib tiegħek se jikkurak kif jixraq.
Like all medicines, MabCampath can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, MabCampath jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects mentioned below are usually due to MabCampath because it affects the body’ s immune system in general and reduces resistance to infection.
L- effetti sekondarji msemmija hawn isfel ġeneralment iseħħu minħabba MabCampath għaliex dan jaffetwa s- sistema immuni tal- ġisem b’ mod ġenerali u jnaqqas ir- reżistenza għall - infezzjonijiet.
Some infections may be serious and sometimes fatal.
Xi infezzjonijiet jistgħu jkunu serji u xi kultant fatali.
Your doctor may give you other medicines or change your dosage to help to reduce any side effects (see section 2 “ Take Special care”).
It- tabib tiegħek jista ’ jagħtik xi mediċini oħra jew jibdel id- dożaġġ biex inaqqas l- effetti sekondarji (ara sezzjoni 2 “ Oqgħod attent ħafna b’ MabCampath ”).
If you are not sure what the side effects below are, ask your doctor to explain them to you.
50 Jekk m’ intiex żgur x’ inhuma l- effetti sekondarji msemmijin isfel, staqsi lit- tabib tiegħek biex jispjegahomlok.
If any of the side effects gets serious, or if you notice any effects not mentioned below, tell your doctor or your pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin isfel, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
46 Very common side effects (affects more than 1 patient in 10):
Effetti sekondarji komuni ħafna (jaffettwaw aktar minn persuna waħda minn kull 10):
Usually one or more of these effects happen during the first week after the start of treatment.
Ġeneralment wieħed jew aktar minn dawn l- effetti jseħħu fl- ewwel ġimgħa wara l- bidu tal- kura.
They are usually only mild or moderate problems and they gradually diminish during the course of treatment.
Ġeneralment dawn huma problemi ħfief sa moderati u jonqsu b’ mod gradwali matul il- kors tal- kura.
• fever, shivering/ chills, sweating, nausea (feeling sick), vomiting, low blood pressure, low white/ red blood cell levels, generalised serious infection, blisters, low blood platelet levels, tiredness, rash, itching, red raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.
• deni, tertir/ sirdat, għaraq, tqalligħ (tħossok ma tiflaħx), rimettar, pressjoni baxxa, għadd ta ’ ċelluli bojod/ ħomor fid- demm baxx, infezzjoni ġeneralizzata serja, nfafet, għadd ta ’ plejtlits fid - demm baxx, għeja, raxx, ħakk, leżjonijiet ħomor ibbuzzati fil- ġilda, qtugħ ta ’ nifs, uġigħ ta ’ ras, dijarea u nuqqas t' aptit.
• Pneumonia.
• Pnewmonja.
Your doctor may give you additional antibiotic and/ or antiviral treatment to reduce the risk of development of this and other infections.
It- tabib tiegħek jista ’ jagħtik xi kura oħra b’ anti- bijotiku u / jew anti- virali biex inaqqas ir- riskju ta ’ żvilupp ta ’ din l- infezzjoni u oħrajn.
Common (affects 1 to 10 patients in 100):
Komuni (jaffettwaw minn persuna sa 10 persuni minn kull 100):
Uncommon (affects 1 to 10 patients in 1,000) may be more serious in nature and include:
Mhux komuni (jaffettwaw minn persuna sa 10 persuni minn kull 1, 000) jistgħu jkunu ta ’ natura aktar serja u jinkludu: • disturbi fil- mudullun tal- għadam • disturbi fil- qalb (tieqaf il- qalb, attakk ta ’ qalb, konġestjoni fil- qalb, rata tal- qalb mgħaġġla b’ mod mhux normali, tnaqqis fir- rata tal- qalb, rata irregolari tal- qalb, uġigħ fis- sider) • disturbi tad- demm (kontenut baxx ta ’ ossiġnu fid- demm, tagħqid tad- demm anormali, tnaqqis fil- proteina, livelli baxxi ta ’ potassju, għadd baxx ta ’ ċelluli bojod tad- demm) • zokkor għoli fid- demm • reazzjonijiet awtoimmuni (infjammazzjoni tat- tirojde)
• bone marrow disorders • heart disorders (heart stopping, heart attack, heart congestion, abnormally fast heart rate, reduced heart rate, irregular heart rate, chest pain) • blood disorders (low blood oxygen content, abnormal clotting, decreased protein, low potassium levels, low number of white blood cells) • high blood sugar • autoimmune reactions (inflammation of the thyroid) • bleeding and inflammation of the gums, nosebleeds • fluid in the lungs, difficulty breathing, runny nose, abnormal findings in the lungs, lymph gland disorders • nervousness 47 • decreased appetite • abnormal thinking • ringing sound in the ears • hiccups • deafness • hoarseness • dizziness • abnormal kidney function • diabetes • bladder and urine infection • viral infection of the eye • stomach ache, paralysis of the small bowel • impotence • fainting, unsteadiness, disorder in muscle tension • swelling around the eyes, inflammation of the eye (conjunctivitis) • sensitivity of the skin, skin rashes, allergic reactions (hypersensitivity) • pneumonia, shingles • diarrhoea • joint pain, muscle pain • serious generalised infection, bruising or swelling at the injection site, ring worm infection of the skin.
51 • fsada u infjammazzjoni tal- ħanek, l- imnieħer jinfaraġ • fluwidu fil- pulmuni, diffikultà biex tieħu n- nifs, imnieħer iqattar, affarijiet anormali fil- pulmun, disturbi tal- glandoli limfatiċi • nervi • tnaqqis fl- aptit • mod ta ’ ħsieb mhux normali • ħoss fil- widnejn, • sulluzzu • truxija • ħanqa • sturdament • funzjoni mhux normali tal- kliewi • dijabete • infezzjoni fil- bużżieqa ta ’ l- awrina u fl- awrina • infezzjoni virali ta ’ l- għajnejn • uġigħ fl- istonku, paralisi fil- musrana ż- żgħira • impotenza • ħass ħażin, nuqqas ta ’ stabbiltà, disturbi fit- tensjoni tal- muskoli, • nefħa madwar l- għajnejn, infjammazzjoni ta ’ l- għajnejn (konġuntivite) • sensittività tal- ġilda, raxx tal- ġilda, reazzjonijiet allerġiċi (sensittività eċċessiva) • pnewmonja, ħruq ta ’ Sant Antnin • dijarea • uġigħ fil- ġogi, uġigħ fil- muskoli • infezzjoni ġeneralizzata serja, tbenġil jew nefħa fil- lok tal- injezzjoni, ħżież fuq il- ġilda.
Rare (affects 1 to 10 patients in 10,000)
Rari (jaffettwaw minn persuna sa 10 persuni minn kull 10, 000)
• tumour lysis syndrome is a special disorder which may begin with pains in the side and blood in the urine • bleeding in the brain (intracranial haemorrhage).
• sindrome tad- disintegrazzjoni tat- tumur huwa disturb speċjali li jista ’ jibda b’ uġigħ fil- ġenb u demm fl- awrina • emorraġija fil- moħħ (emorraġija intrakranjali).
Serious side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, autoimmune phenomena, low red blood cell and low blood platelet levels have occurred with fatal outcome in rare cases.
Effetti serji oħra li jinkludu diffikultà biex tieħu n- nifs, infjammazzjoni tal- pulmuni, qtugħ ta ’ nifs estrem, ħass ħażin, attakk tal- qalb, fenomena awtoimmuni, livell baxx ta ’ ċelluli ħomor u ta ’ plejtlits fid- demm seħħew b’ konsegwenzi fatali f’ każijiet rari.
Tell your doctor immediately if you experience any of these side effects.
Għid lit- tabib tiegħek minnufih jekk ikollok xi wieħed minn dawn l- effetti sekondarji.
In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.
Barra dan, kien irrapportat ittestjar li indika l- preżenza ta 'antikorpi li jistgħu jiddistruġġu ċ- ċelluli ħomor tad- demm (Test ta' Coombs).
HOW TO STORE MABCAMPATH
KIF TAĦŻEN MABCAMPATH
Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the ampoule label.
Tużax MabCampath wara d- data ta ’ skadenza (JIS) li tidher fuq il- kartuna ta 'barra u t- tikketta ta' l - ampulla.
Store in a refrigerator (2°C-8°C).
Aħżen fi friġġ (2 °C- 8° C).
Store in the original packaging in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl.
Medicines should not be disposed of via wastewater or household waste.
52 Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- dranaġġ jew ma' l- iskart domestiku.
Your healthcare professional will dispose of medicines no longer required.
Il - professjonist fil- qasam tas- saħħa tiegħek se jarmi mediċini li m' għandekx bżonn.
These measures will help protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni ta 'l- ambjent.
What MabCampath contains
X' fih MabCampath
The active substance is alemtuzumab.
Is- sustanza attiva hi alemtuzumab.
The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate and water for injections.
Is- sustanzi l- oħra huma disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate u ilma għall- injezzjonijiet.
What MabCampath looks like and contents of the pack
Id- dehra ta 'MabCampath u l- kontenuti tal- pakkett
MabCampath is a concentrate for solution for infusion that comes in a glass ampoule.
MabCampath huwa konċentrat għal soluzzjoni għall- infużjoni disponibbli f’ ampulla tal- ħġieġ.
Each pack of MabCampath contains 3 ampoules.
Kull pakkett ta 'MabCampath fih 3 ampulli.
Manufacturer
Il- Manifattur:
Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.
Bayer Schering Pharma AG, Müllerstrasse 178, D- 13342 Berlin, Il- Ġermanja.
Tél/ Tel: +32 (0)2 535 63 11
53 Luxembourg/ Luxemburg België/ Belgique/ Belgien Bayer S. A. / N. V.
България Байер България ЕООД Тел. +359 02 81 401 01
Magyarország България Bayer Hungária KFT Байер България ЕООД Тел. +359 02 81 401 01
Italia Bayer S. p. A.
Suomi/ Finland Italia Bayer Oy, Bayer Schering Pharma Bayer S. p. A.
Tel: +39 02 397 81
Puh/ Tel: +358 20 785 21 Tel: +39 02 397 81
50 Lietuva UAB Bayer, Bayer Schering Pharma Tel: +370 52 33 68 68
54 Lietuva UAB Bayer, Bayer Schering Pharma Tel: +370 52 33 68 68
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar fi:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website tal- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss huwa maħsub għall- professjonisti fil- qasam mediku biss:
The ampoule contents should be inspected for particulate matter and discolouration prior to administration.
Il- kontenut tal- ampulla għandu jiġi spezzjonat għal frak żgħir u għal kull tibdil fil- kulur qabel ma jingħata.
If particulate matter is present or the solution is coloured, then the ampoule should not be used.
Jekk hemm xi frak jew is- soluzzjoni hija kulurita, l- ampulla m' għandiex tintuża.
MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light.
MabCampath ma fihx preservattivi kontra l- mikrobi, u għalhekk huwa rrakkomandat li MabCampath jiġi ppreparat għall- infużjoni fil- vini permezz ta ’ teknika asettika u li s- soluzzjoni għall- infużjoni tiġi mogħtija fi żmien 8 siegħat wara l- preparazzjoni u mħarsa mid- dawl.
The required amount of the ampoule contents should be added, via a sterile, low-protein binding, non-fibre 5 μ m filter, to 100 ml of sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
L- ammont meħtieġ tal- kontenut ta ’ l- ampulla għandu jiġi miżjud ma ’ 100 ml ta ’ soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew ta ’ glucose (5%), permezz ta ’ filtru sterili ta ’ 5 µm, li mhux tal- fibra u li ma tantx jorbot proteini.
Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused though the same intravenous line.
Prodotti mediċinali oħra m' għandhomx jiġu miżjuda mas- soluzzjoni għall- infużjoni ta ’ MabCampath u m’ għandhomx jiġu infużi fl- istess waqt mill- istess pajp għal ġol- vina.
51 PACKAGE LEAFLET:
55 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you start taking this medicine
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
Patients with chronic lymphocytic leukaemia (CLL) have too many abnormal lymphocytes, which displace healthy cells in the bone marrow where most new blood cells are formed.
Pazjenti li għandhom lewkimja limfoċitika kronika (CLL) għandhom iżżejjed limfoċiti anormali, li jissostitwixxu ċelluli b' saħħithom fil- mudullun fejn il- biċċa l- kbira taċ- ċelluli l- ġodda tad- demm jiġu fformati.
52 • steroids, antihistamines or analgesics (treatment for fever) to help to reduce some of the side effects.
Inti tista ’ tingħata wkoll 56 • sterojdi, antistamini jew analġeżiċi (kura għad- deni) biex jgħinu jtaffu xi ftit mill- effetti sekondarji.
You will be examined for symptoms of a certain type of viral infection called CMV (cytomegalovirus) during your MabCampath therapy and for at least 2 months afterwards.
Waqt it- terapija tiegħek b’ ManCampath u għal ta ’ lanqas xahrejn wara inti se tiġi eżaminat għal sintomi ta ’ ċertu tip ta ’ infezzjoni virali li tissejjaħ cytomegalovirus (CMV).
Your doctor will monitor you carefully if you
It- tabib tiegħek ser jissorveljak b’ attenzjoni, jekk inti • għandek mard tal- qalb jew uġigħ fis- sider u/ jew qed tirċievi kura biex tnaqqas il- pressjoni tad- demm, peress li MabCampath jista ’ jaggrava dawn il- kundizzjonijiet.
Patients with these conditions may be at higher risk of a heart attack.
• fil- passat inti ġejt ikkurat b' kimoterapiji jew mediċini ġenerali li għandhom riskju għoli li jikkaġunaw ħsara lill- qalb, it- tabib tiegħek għandu mnejn ikun jixtieq jimmonitorja l- funzjoni kardijaka tiegħek (ECG, rata tal- qalb, piż tal- ġisem) waqt li tkun qed tirċievi MabCampath.
• have been treated in the past with chemotherapies or general medications that have a high risk of causing heart damage, your doctor may wish to monitor your cardiac function (ECG, heart rate, body weight) while receiving MabCampath.
• ikollok effetti sekondarji oħra, ħafna drabi disturbi marbuta mad- demm ikkawżati minn
You may experience an allergic or hypersensitivity reaction to MabCampath solution, especially against the protein contained in it, while the infusion is given to you.
Jista ’ jkollok esperjenza ta ’ reazzjoni allerġika jew ta ’ sensittività eċessiva għas- soluzzjoni ta ’ MabCampath, speċjalment kontra l- proteina li tinsab fiha, waqt li tkun qed tingħata l- infużjoni.
Pregnancy
57 Tqala
53 • are pregnant or you think you may be pregnant, you should tell your doctor immediately. • are of childbearing potential, then you should avoid becoming pregnant by using effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.
• tqila, jew taħseb li tista ’ tkun tqila, għandek tgħarraf lit- tabib tiegħek minnufih. • jista ’ jkollok it- tfal, għandek tevita li toħroġ tqila billi tuża mezzi effettivi ta ’ kontraċezzjoni qabel ma ’ tibda l- kura, waqt il- kura u għal 6 xhur wara li tintemm il- kura.
MabCampath is contained in solution in a glass vial.
MabCampath jinsab f’ soluzzjoni f' kunjett tal- ħġieġ.
The vial contents are added to a sodium chloride or glucose solution contained in a drip bag.
Il- kontenut tal- kunjett huwa miżjud ma ’ soluzzjoni ta ’ sodium chloride jew glucose li tinsab f’ borża tad- dripp.
If you are not sure what the side effects below are, ask your doctor to explain them to you.
58 Jekk m’ intiex żgur x’ inhuma l- effetti sekondarji msemmijin isfel, staqsi lit- tabib tiegħek biex jispjegahomlok.
Very common side effects (affects more than 1 patient in 10):
Effetti sekondarji komuni ħafna (jaffettwaw aktar minn persuna waħda minn kull 10):
54 Usually one or more of these effects happen during the first week after the start of treatment.
Ġeneralment wieħed jew aktar minn dawn l- effetti jseħħu fl- ewwel ġimgħa wara l- bidu tal- kura.
• fever, shivering/ chills, sweating, nausea (feeling sick), vomiting, low blood pressure, low white/ red blood cell levels, generalised serious infection, blisters, low blood platelet levels, tiredness, rash, itching, red raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.
Ġeneralment dawn huma problemi ħfief sa moderati u jonqsu b’ mod gradwali matul il- kors tal- kura. • deni, tertir/ sirdat, għaraq, tqalligħ (tħossok ma tiflaħx), rimettar, pressjoni baxxa, għadd ta ’ ċelluli bojod/ ħomor fid- demm baxx, infezzjoni ġeneralizzata serja, nfafet, għadd ta ’ plejtlits fid - demm baxx, għeja, raxx, ħakk, leżjonijiet ħomor ibbuzzati fil- ġilda, qtugħ ta ’ nifs, uġigħ ta ’ ras, dijarea u nuqqas t' aptit.
• bone marrow disorders • heart disorders (heart stopping, heart attack, heart congestion, abnormally fast heart rate, reduced heart rate, irregular heart rate, chest pain) • blood disorders (low blood oxygen content, abnormal clotting, decreased protein, low potassium levels, low number of white blood cells) • high blood sugar • autoimmune reactions (inflammation of the thyroid) • bleeding and inflammation of the gums, nosebleeds • fluid in the lungs, difficulty breathing, runny nose, abnormal findings in the lungs, lymph gland disorders • nervousness • decreased appetite 55 • abnormal thinking • ringing sound in the ears • hiccups • deafness • hoarseness • dizziness • abnormal kidney function • diabetes • bladder and urine infection • viral infection of the eye • stomach ache, paralysis of the small bowel • impotence • fainting, unsteadiness, disorder in muscle tension • swelling around the eyes, inflammation of the eye (conjunctivitis) • sensitivity of the skin, skin rashes, allergic reactions (hypersensitivity) • pneumonia, shingles • diarrhoea • joint pain, muscle pain • serious generalised infection, bruising or swelling at the injection site, ring worm infection of the skin.
59 • fluwidu fil- pulmuni, diffikultà biex tieħu n- nifs, imnieħer iqattar, affarijiet anormali fil- pulmun, disturbi tal- glandoli limfatiċi • nervi • tnaqqis fl- aptit • mod ta ’ ħsieb mhux normali • ħoss fil- widnejn, • sulluzzu • truxija • ħanqa • sturdament • funzjoni mhux normali tal- kliewi • dijabete • infezzjoni fil- bużżieqa ta ’ l- awrina u fl- awrina • infezzjoni virali ta ’ l- għajnejn • uġigħ fl- istonku, paralisi fil- musrana ż- żgħira • impotenza • ħass ħażin, nuqqas ta ’ stabbiltà, disturbi fit- tensjoni tal- muskoli, • nefħa madwar l- għajnejn, infjammazzjoni ta ’ l- għajnejn (konġuntivite) • sensittività tal- ġilda, raxx tal- ġilda, reazzjonijiet allerġiċi (sensittività eċċessiva) • pnewmonja, ħruq ta ’ Sant Antnin • dijarea • uġigħ fil- ġogi, uġigħ fil- muskoli • infezzjoni ġeneralizzata serja, tbenġil jew nefħa fil- lok tal- injezzjoni, ħżież fuq il- ġilda.
• tumour lysis syndrome is a special disorder which may begin with pains in the side and blood in the urine • bleeding in the brain (intracranial haemorrhage).
Rari (jaffettwaw minn persuna sa 10 persuni minn kull 10, 000) • sindrome tad- disintegrazzjoni tat- tumur huwa disturb speċjali li jista ’ jibda b’ uġigħ fil- ġenb u demm fl- awrina • emorraġija fil- moħħ (emorraġija intrakranjali).
Serious side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, autoimmune phenomena, low red blood cell and low blood platelet levels, have occurred with fatal outcome in rare cases.
Effetti serji oħra li jinkludu diffikultà biex tieħu n- nifs, infjammazzjoni tal- pulmuni, qtugħ ta ’ nifs estrem, ħass ħażin, attakk tal- qalb, fenomena awtoimmuni, livell baxx ta ’ ċelluli ħomor u ta ’ plejtlits fid- demm seħħew b’ konsegwenzi fatali f’ każijiet rari.
Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the vial label.
Tużax MabCampath wara d- data ta ’ skadenza (JIS) li tidher fuq il- kartuna ta 'barra u t- tikketta tal - kunjett.
56 6.
60 6.
One ml contains 30 mg of alemtuzumab.
Ml fih 30 mg ta ’ alemtuzumab.
Each vial contains 30 mg of alemtuzumab.
Kull kunjett fih 30 mg ta ’ alemtuzumab.
MabCampath is a concentrate for solution for infusion that comes in a glass vial.
MabCampath huwa konċentrat għal soluzzjoni għall- infużjoni disponibbli f’ kunjett tal- ħġieġ.
Each pack of MabCampath contains 3 vials.
Kull pakkett ta 'MabCampath fih 3 kunjetti.
Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.
Bayer Schering Pharma AG, Müllerstrasse 178, D- 13342 Berlin, il- Ġermanja.
Tél/ Tel: +32 (0)2 535 63 11
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This leaflet was last approved in
62 Dan il- fuljett kien approvat l- aħħar fi:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: 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
The vial contents should be inspected for particulate matter and discolouration prior to administration.
Il- kontenut tal- kunjett għandu jiġi spezzjonat għal frak żgħir u għal kull tibdil fil- kulur qabel ma jingħata.
If particulate matter is present or the solution is coloured, then the vial should not be used.
Jekk hemm xi frak jew is- soluzzjoni hija kulurita, l- kunjett m' għandux jintuża.
What is MabThera?
X' inhu MabThera?
MabThera is a concentrate to be made up into a solution for infusion (drip into a vein).
MabThera huwa konċentrat li jinħall f' soluzzjoni għall- infużjoni (dripp fil- vina).
MabThera contains 100 mg or 500 mg of the active substance rituximab.
MabThera fih 100 mg jew 500 mg tas- sustanza attiva rituximab.
What is MabThera used for?
Għal xiex jintuża MabThera?
MabThera is used in adults to treat two types of non-Hodgkin’ s lymphoma (a cancer of the lymph tissue), both of which affect a type of white blood cell called B-lymphocytes: • In follicular lymphoma, MabThera is used in combination with chemotherapy in patients with advanced disease who have not been treated before.
MabThera jintuża f' adulti biex jittratta żewġ tipi ta 'linfoma mhux ta' Hodgkin (kanċer tat- tessut linfatiku), li t- tnejn jolqtu tip ta 'ċelluli tad- demm bojod magħrufa bħala linfoċiti B: • Fil- linfoma follikulari, MabThera jintuża flimkien mal- kemjoterapija f' pazjenti bil- marda fi stat avvanzat li ma tkunx ġiet ittrattata qabel.
It can also be used as maintenance treatment in patients whose follicular lymphoma has come back after previous treatment, provided that the lymphoma has responded to induction treatment (an earlier round of treatment).
Jista 'jintuża wkoll bħala trattament ta' manteniment fil - pazjenti li l- linfoma follikulari tagħhom tkun irkadiet wara trattament preċedenti, sat- trattament ta 'induzzjoni (fażi preċedenti ta' trattament).
It is also used on its own in patients with advanced disease who are resistant to other anticancer medicines (chemotherapy) or who have failed two or more chemotherapy treatments. • In patients with diffuse large B-cell lymphoma, MabThera is used in combination with a specific type of chemotherapy called ‘ CHOP’ (cyclophosphamide, doxorubicin, vincristine and prednisolone).
Jintuża wkoll waħdu f' pazjenti li jkollhom il- marda fi stat avvanzat reżistenti għal mediċini oħra kontra l- kanċer (kemjoterapija) jew li jkunu fallewlhom żewġ trattamenti jew iktar tal- kemjoterapija. • Fil- pazjenti bil- linfoma taċ- ċelluli B, MabThera jintuża flimkien ma 'tip speċifiku ta' kemjoterapija magħrufa bħala 'CHOP' (ċiklofosfamida, doxorubicin, vinkristina u prednisolone).
In addition, MabThera can be used to treat adults with severe rheumatoid arthritis (a disease that causes inflammation of the joints).
Barra minn hekk, MabThera jista 'jintuża fit- trattament ta' adulti bl- artrite rewmatojde gravi( marda li tikkawża infjammazzjoni tal- ġogi).
MabThera is used in combination with methotrexate (a medicine that acts on the immune system) in patients who cannot take or have not responded adequately to other treatments, including treatment containing a tumour necrosis factor (TNF) inhibitor (a type of medicine for rheumatoid arthritis).
MabThera jintuża flimkien ma 'methotrexate (mediċina li taġixxi fuq is- sistema immunitarja) f' pazjenti li ma jkunux jistgħu jieħdu jew ma jkunux irrispondew biżżejjed għal trattamenti oħra, inkluż inibitur tal- fattur tan- nekrożi tumurali (TNF) (tip ta' mediċina għall- artrite rewmatojde).
How is MabThera used?
Kif jintuża MabThera?
MabThera is given in hospital.
MabThera jingħata fl- isptar.
Patients should be given an antihistamine and a painkiller before each infusion.
Il- pazjenti għandhom jingħataw antistamina u mediċina għal kontra l - uġigħ qabel kull infużjoni.
They may also need a corticosteroid to reduce inflammation (especially in rheumatoid arthritis).
Jistgħu jingħataw ukoll kortikosterojde biex inaqqas l- infjammazzjoni (speċjalment fl- artrite rewmatojde).
In the treatment of non-Hodgkin’ s lymphoma, the usual dose of MabThera is 375 mg per square metre body surface area (calculated using the patient ’ s height and weight).
Fit- trattament tal- linfoma mhux ta 'Hodgkin, id- doża normali ta' MabThera hija 375 mg għal kull metru kwadru erja tal- wiċċ (ikkalkulata mit- tul u mill- piż tal- pazjent).
The number and frequency of infusions depends on the type of lymphoma being treated.
L- għadd u l- frekwenza tal - infużjonijiet jiddependu mit- tip tal- linfoma li tkun qed tiġi ttrattata.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR) għad- dettalji kollha.
How does MabThera work?
Kif jaħdem MabThera?
The active substance in MabThera, rituximab, is a monoclonal antibody.
Is- sustanza attiva f' MabThera, rituximab, huwa antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Antikorp monoklonali huwa antikorp (tip ta 'proteina) li huwa maħsub biex jagħraf u jintrabat ma' struttura speċifika (magħrufa bħala antiġene) li jinstab fuq ċerti ċelluli fil- ġisem.
Rituximab has been designed to target an antigen called CD20, which is present on the surface of all B-lymphocytes.
Rituximab inħoloq bħala antiġene magħruf bħala CD20, li jinstab fuq wiċċ il- linfoċiti B kollha.
When rituximab binds to the antigen, this causes lysis (cell death).
Meta rituximab ikun intrabat mal- antiġene, dan jikkawża liżi (qerda taċ- ċelluli).
This helps in lymphoma, since the cancerous B-cells are destroyed.
Dan jgħin fil- linfoma, billi jinqerdu ċ- ċelluli B tal- kanċer.
In rheumatoid arthritis, the B-cells are destroyed in the joints, helping to reduce inflammation.
Fl- artrite rewmatojde, iċ- ċelluli B jinqerdu fil- ġogi, u dan jgħin fit - tnaqqis tal- infjammazzjoni.
How has MabThera been studied?
Kif ġie studjat MabThera?
In follicular lymphoma, MabThera has been studied in a main study involving 322 patients whose follicular lymphoma had not been treated before.
Fil- linfoma follikulari, MabThera ġie eżaminat fi studju ewlieni wieħed bil- parteċipazzjoni ta '322 pazjent li l- linfoma follikulari tagħhom ma kinitx ittrattata qabel.
This study looked at the effectiveness of adding MabThera to standard chemotherapy (CVP: cyclophosphamide, vincristine and prednisolone) by measuring how long it took for the treatment to fail.
Dan l- istudju eżamina l- effikaċja taż - żieda ta 'MabThera mal- kemjoterapija standard (CVP: ċiklofosfamide, vinkristina u prednisolone) billi kejjel iż- żmien li ħa biex falla t- trattament.
Three further studies from the published scientific literature looked at the effects of adding MabThera to other types of chemotherapy in a total of 1,347 patients.
Tliet studji oħra mil- letteratura xjentifika pubblikata ħarsu lejn l- effetti taż- żieda ta 'MabThera ma' tipi oħra ta 'kemjoterapija f' total ta' 1, 347 pazjent.
Two studies looked at MabThera taken alone in patients with follicular lymphoma: one study looked at overall response rate to MabThera in 203 patients who had failed previous treatments and the other study was a maintenance study in 334 patients, looking at the time until the disease got worse.
Żewġ studji analizzaw MabThera meħud waħdu f' pazjenti bil- linfoma follikulari: studju wieħed eżamina r- rata globali ta 'rispons għal MabThera f' 203 pazjenti li kien fallielhom it- trattament preċedenti u l- istudju l- ieħor kien studju ta' manteniment fi 334 pazjent, b' ħarsa lejn kemm għadda żmien sa ma l- marda marret għall- agħar.
In diffuse large B-cell lymphoma, the effectiveness of adding MabThera to CHOP chemotherapy was examined in a study involving 399 patients who were all over 60 years of age.
Fil- linfoma diffuża taċ- ċelluli B, l- effikaċja taż- żieda ta 'MabThera mal- kemjoterapija CHOP kienet eżaminata fi studju bis- sehem ta' 399 pazjent li kollha kellhom iktar minn 60 sena.
The main measure of effectiveness was ‘ event-free survival’ (how long it took for the patients to experience a worsening of their disease, to need a change in treatment or to die).
Il- mezz ewlieni tal - kejl tal- effikaċja kien is - 'sopravivenza mingħajr episodji' (kemm irid jgħaddi żmien biex il- pazjenti jesperjenzaw aggravar tal- marda, ikollhom bżonn tibdil fit- trattament jew imutu).
In rheumatoid arthritis, MabThera was studied in 520 patients.
Fl- artrite rewmatojde, MabThera ġie studjat f' 520 pazjent.
The effectiveness of adding MabThera to methotrexate was compared with that of adding placebo (a dummy treatment).
L- effikaċja taż- żieda ta 'MabThera ma' methotrexate tqabblet ma 'dik taż- żieda tal- plaċebo (trattament finta).
The study measured how many patients experienced a 20% improvement in the key symptoms of rheumatoid arthritis after 24 weeks.
L- istudju kejjel kemm pazjenti kienu esperjenzaw titjib ta '20% fis- sintomi kruċjali tal- artrite rewmatojde wara 24 ġimgħa.
What benefit has MabThera shown during the studies?
X' inhuma l- benefiċċji ta 'MabThera?
In follicular lymphoma, adding MabThera to CVP chemotherapy increased the time taken for the disease to come back from an average of 6.7 to 25.9 months.
Fil- linfoma follikulari, iż- żieda ta 'MabThera mal- kemjoterapija CVP żiedet iż- żmien li jrid jgħaddi biex il- marda tirkadi minn perjodu medju ta' 6. 7 sa 25. 9 xhur.
The three additional studies also showed that adding MabThera to other types of chemotherapy also improved the patients’ outcome.
It- tliet studji addizzjonali wrew ukoll li ż- żieda ta 'MabThera ma' tipi oħra ta 'kemjoterapija tejbu wkoll ir- riżultat fil- pazjenti.
In the studies of MabThera monotherapy, 48% of the patients who had failed previous treatment responded to MabThera, and the maintenance study showed that it took 42.2 months for patients who received MabThera to experience a progression of their disease, compared with 14.3 months in patients who did not receive the medicine.
Fl- istudji tal- monoterapija ta 'MabThera, 48% tal- pazjenti li kien fallielhom it- trattament preċedenti rrispondew għal MabThera, u l- istudju tal- manteniment wera li kellhom jgħaddu 42. 2 xhur biex il - pazjenti li ngħataw MabThera jesperjenzaw progressjoni fil- marda tagħhom, meta mqabbla ma' 14. 3 xhur fil- pazjenti li ma kinux ingħataw il- mediċina.
In diffuse large B-cell lymphoma, adding MabThera to CHOP chemotherapy increased event-free survival from 13 to 35 months.
Fil- linfoma diffuża taċ- ċelluli B kbar, iż- żieda ta 'MabThera mal- kemjoterapija CHOP żiedet ir- riskju ta' sopravivenza mingħajr episodji oħra minn 13 sa 35 xahar.
In rheumatoid arthritis, MabThera was more effective than placebo:
Fl- artrite rewmatojde, MabThera kien iktar effikaċi mill- plaċebo:
51% of patients receiving MabThera had an improvement in symptoms, compared with 18% of the patients receiving placebo.
51% tal- pazjenti li kienu qed jingħataw MabThera kellhom titjib fis- sintomi, meta mqabbla ma '18% ta' pazjenti li kienu qed jingħataw il- plaċebo.
What is the risk associated with MabThera?
X' inhu r- riskju assoċjat MabThera?
When used to treat non-Hodgkin’ s lymphoma, the most common side effects with MabThera (seen in more than 1 patient in 10) are bacterial infections, viral infections, bronchitis (inflammation of the airways in the lungs), neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low levels of leucocytes, another type of white blood cell), febrile neutropenia (neutropenia with fever), reactions related to the infusion (mainly fever, chills and shivering), angioedema (swelling beneath the skin), nausea (feeling sick), pruritus (itching), rash, alopecia (hair loss), fever, chills, asthenia (weakness), headache and decreased levels of IgG (a type of antibody).
Meta jintuża fit- trattament ta 'linfoma mhux ta' Hodgkin, l- effetti sekondarji l- aktar komuni b' MabThera (li dehru f' iktar minn pazjent 1 minn kull 10) huma infezzjonijiet batteriċi, infezzjonijiet virali, bronkite (infjammazzjoni tal- passaġġi tan- nifs fil- pulmun), newtropenija (livelli baxxi ta 'newtrofili, tip ta' ċellula tad- demm bajda), lewkopenija (livelli baxxi ta 'lewkoċiti, tip ieħor ta' ċellula tad- demm bajda), newtropenija febbrili (newtropenija bid- deni), reazzjonijiet relatati mal- infużjoni (l - iktar deni u tertir), anġjoedema (nefħa taħt il- ġilda), nawżea (dardir), ħakk, raxx, alopeċja (telf ta 'xagħar), deni, tertir, astenija (debbolezza), uġigħ ta' ras u livelli iktar baxxi ta 'IgG (tip ta' antikorp).
When used to treat rheumatoid arthritis, the most common side effect (seen in more than 1 patient in 10) is infection.
Meta jintuża fit- trattament tal- artrite rewmatojde, l- effett sekondarju l- aktar komuni (li deher f' iktar minn pazjent 1 minn kull 10) huwa infezzjoni.
For the full list of all side effects reported with MabThera, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b' MabThera, ara l- Fuljett ta 'Tagħrif.
MabThera should not be used in people who may be hypersensitive (allergic) to rituximab, mouse proteins, or any of the other ingredients.
MabThera m' għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal rituximab, proteini tal- ġurdien, jew għal kwalunkwe sustanza oħra tiegħu.
In addition, patients with rheumatoid arthritis should not receive MabThera if they have an active severe infection, severe heart failure or severe heart disease.
Barra minn hekk, il- pazjenti bl- artrite rewmatojde m' għandhomx jingħataw MabThera jekk ikollhom infezzjoni gravi, insuffiċjenza kardijaka gravi jew mard tal- qalb gravi.
2/ 3 Why has MabThera been approved?
2/ 3 Għaliex ġie approvat MabThera?
The Committee for Medicinal Products for Human Use (CHMP) decided that MabThera’ s benefits are greater than its risks for the treatment of non-Hodgkin’ s lymphoma and rheumatoid arthritis.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'MabThera huma ogħla mir- riskji tiegħu għat- trattament ta' linfoma mhux ta 'Hodgkin u tal- artrite rewmatojde.
The Committee recommended that MabThera be given marketing authorisation.
Il- Kumitat irrakkomanda li MabThera jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about MabThera:
Informazzjoni oħra dwar MabThera:
The European Commission granted a marketing authorisation valid throughout the European Union for MabThera to Roche Registration Limited on 2 June 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha għal MabThera lil Roche Registration Limited fit- 2 ta 'Ġunju 1998.
The marketing authorisation was renewed on 2 June 2003 and on 2 June 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 2 ta 'Ġunju 2003 u fit- 2 ta' Ġunju 2008.
The full EPAR for MabThera is available here.
L- EPAR sħiħ għal MabThera jista 'jiġi kkonsultat hawn.
Concentrate for solution for infusion
Konċentrat għal soluzzjoni għall - infużjoni
10 ml (10 mg/ ml)
10 ml (10 mg/ ml) 2
2 vials
kunjetti
1 vial
Kunjett wieħed
MabThera 100 mg (10 mg/ ml) concentrate for solution for infusion
MabThera 100 mg (10 mg/ ml) konċentrat għal soluzzjoni għal infużjoni
Each solution contains 10 mg/ ml of Rituximab.
Kull soluzzjoni fiha 10 mg/ ml ta ’ Rituximab.
Each single-use vial containing 100 mg of Rituximab.
Kull kunjett għall- użu ta ’ darba fih 100 mg ta ’ Rituximab.
Rituximab is a genetically engineered chimeric mouse/ human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy- chain variable region sequences.
Rituximab huwa antikorp monoklonali magħmul minn inġinerija ġenetika kimeriku tal- ġurdien u tal - bniedem li jirrappreżenta immunoglobulin glikosilat b’ sekwenzi ta ’ reġġjun kostanti ta ’ IgG1 uman, u sekwenzi ta ’ reġjun varjabbli ta ’ light- chain u heavy- chain tal- ġrieden.
The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
L- antikorp huwa magħmul permezz ta ’ koltura ta ’ suspensjoni ta ’ ċelluli mammiferi (ovarju tal- ħamster Ċiniż) u ppurifikat bi kromatografija ta ’ l- affinità u skambju tal- jone, inkluża l- inattivazzjoni virali speċifika u proċeduri tat - tneħħija.
Concentrate for solution for infusion.
Konċentrat għal soluzzjoni għal infużjoni
Clear, colourless liquid.
Likwidu ċar, mingħajr kulur.
Non-Hodgkin’ s lymphoma (NHL)
Limfoma mhux ta ’ Hodgkin
MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
MabThera huwa indikat għall- kura ta ’ pazjenti b’ limfoma follikulari fl- istadju III- IV li ma kinux ikkurati qabel flimkien ma ’ kimoterapija.
MabThera maintenance therapy is indicated for patients with relapsed/ refractory follicular lymphoma responding to induction therapy with chemotherapy with or without MabThera.
It- terapija ta ’ manteniment b’ MabThera hija indikata għal pazjenti b’ limfoma follikulari li reġgħet tfaċċat/ refrattarja li jirrispondu għal terapija ta ’ induzzjoni bi jew mingħajr MabThera.
MabThera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
Monoterapija b’ MabThera hija ndikata għall- kura ta ’ pazjenti b’ limfoma follikulari fi stadju III- IV li huma kimoreżistenti jew li reġgħet tfaċċat għat- tieni darba jew aktar wara l- kimoterapija.
MabThera is indicated for the treatment of patients with CD20 positive diffuse large B cell non- Hodgkin’ s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
MabThera jiġi indikat għall- kura ta ’ pazjenti b’ limfoma mhux ta ’ Hodgkin ta ’ ċellula B kbira f’ tixrid pożittiv CD20 flimkien ma ’ kimoterapija CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone).
Chronic lymphocytic leukaemia
Lewkimja limfoċitika kronika
MabThera is indicated for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.
MabThera huwa indikat għall- kura preferita ta ’ pazjenti b’ lewkimja limfoċitika kronika (CLL) flimkien ma ’ kimoterapija.
See section 5.1 for further information.
Ara sezzjoni 5. 1 għal aktar informazzjoni.
Rheumatoid arthritis
2 Artrite rewmatika
MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-
MabThera flimkien ma ’ methotrexate huwa indikat għall- kura ta ’ pazjenti adulti b’ artrite rewmatika attiva severa li kellhom rispons inadegwat jew intolleranza għal mediċini anti- rewmatiċi oħra li jimmodifikaw il- marda (DMARD) fosthom terapija ta ’ inibizzjoni waħda jew aktar tal- fattur tan - nekrosi tat- tumuri (TNF).
MabThera infusions should be administered under the close supervision of an experienced physician, and in an environment where full resuscitation facilities are immediately available.
L- infużjonijiet ta ’ MabThera għandhom jingħataw taħt superviżjoni mill- qrib ta ’ tabib b’ esperjenza u f’ ambjent fejn ikun hemm disponibbli b’ mod immedjat faċilitajiet sħaħ ta ’ risuxxitazzjoni.
Non-Hodgkin’ s lymphoma
Limfoma mhux ta ’ Hodgkin
Dosage adjustments during treatment No dose reductions of MabThera are recommended.
Aġġustamenti fid- doża waqt il- kura Mhux irrakkomandat tnaqqis fid- doża ta ’ MabThera.
When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Meta MabThera jingħata flimkien ma ’ kimoterapija, għandu jiġi applikat tnaqqis tad- doża stàndard għall- prodotti mediċinali kimoterapewtiċi.
Combination therapy The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular NHL is:
Limfoma follikulari mhux ta ’ Hodgkin Terapija kombinata Id- doża rrakkomandata ta ’ MabThera f’ taħlita ma ’ kimoterapija għall- kura ta ’ induzzjoni ta ’ pazjenti b’ NHL follikulari li ma kienux ikkurati jew li reġgħet tfaċċat il- marda/ reżistenti hija ta ’:
375 mg/ m2 body surface area per cycle, for up to 8 cycles.
375 mg/ m2 ta ’ l- erja tas- superfiċje tal- ġisem kull ċiklu, sa 8 ċikli.
Mabthera should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Mabthera għandu jingħata fl- ewwel ġurnata ta ’ kull ċiklu ta ’ kimoterapija, wara l- għoti fil- vini tal - komponent glucocorticoid tal- kimoterapija jekk japplika.
Monotherapy/ Maintenance The recommended dose of MabThera used as a maintenance treatment for patients with relapsed/ refractory follicular NHL who have responded to induction treatment with chemotherapy, with or without MabThera is:
Monoterapija/ manteniment Id- doża rrakkomandata ta ’ MabThera użata bħala kura ta ’ manteniment għal pazjenti b’ NHL li reġgħet tfaċċat/ reżistenti li rrispondew għall- kura ta ’ induzzjoni b’ kimoterapija, bi jew bla MabThera hija:
375 mg/ m2 body surface area once every 3 months until disease progression or for a maximum period of two years.
375 mg/ m2 ta ’ l- erja tas- superfiċje tal- ġisem darba kull 3 xhur sal- progressjoni tal- marda jew għall - perijodu massimu ta ’ sentejn.
The recommended dose of MabThera monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is:
Id- doża rrakkomandata ta ’ monoterapija b’ MabThera wżata bħala kura ta ’ induzzjoni għall- pazjenti adulti b’ limfoma follikulari ta ’ stadju III- IV li huma kimoreżistenti jew li qegħdin fit- tieni jew aktar episodju ta ’ rkadar wara kimoterapija hija:
375 mg/ m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
375 mg/ m2 ta ’ l- erja tas- superfiċje tal- ġisem, mogħtija bħala infużjoni fil- vini darba fil- ġimgħa għal erba ’ ġimgħat.
For retreatment with MabThera monotherapy for patients who have responded to previous treatment with MabThera monotherapy for relapsed/ refractory follicular NHL, the recommended dose is:
Għal kura mill- ġdid b’ monoterapija b’ MabThera għall- pazjenti li rrispondew għal kura minn qabel b’ monoterapija b’ MabThera għal NHL follikulari li reġgħet tfaċċat/ reżistenti, id- doża rakkomandata hija:
375 mg/ m2 body surface area, administered as an intravenous infusion once weekly for four weeks (see section 5.1).
375 mg/ m2 ta ’ l- erja tas- superfiċje tal- ġisem, mogħtija bħala infużjoni fil- vini darba fil- ġimgħa għal erba ’ ġimgħat (ara sezzjoni 5. 1).
Diffuse large B cell non-Hodgkin's lymphoma MabThera should be used in combination with CHOP chemotherapy.
Limfoma mhux ta ’ Hodgkin mifruxa taċ- ċelluli B kbar MabThera għandu jintuża flimkien ma ’ kimoterapija CHOP.
The recommended dosage is 375 mg/ m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP.
Id- doża rakkomandata hija ta ’ 375 mg/ m2 ta ’ arja tas- superfiċje tal- ġisem, amministrata fl- ewwel ġurnata ta ’ kull ċiklu ta 'kimoterapija għal 8 ċikli wara l- infużjoni fil- vini tal- komponent glukokortikojdi ta ’ CHOP.
Safety and efficacy of MabThera have not been established in combination with other chemotherapies in diffuse large B cell non- Hodgkin’ s lymphoma.
Is- sigurtà u l- effikaċja ta ’ MabThera ma ġewx stabbiliti flimkien ma ’ kimoterapiji oħrajn f’ limfoma mhux ta ’ Hodgkin mifruxa taċ- ċelluli B kbar.
Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome.
Għall- pazjenti b’ CLL huwa rrakkomandat profilassi b’ idratazzjoni adegwata u l- għoti ta ’ urikostatiċi minn 48 siegħa qabel il- bidu tat- terapija biex jitnaqqas ir- riskju tas- sindrome tal- lisi tat- tumur.
For CLL patients whose lymphocyte counts are > 25 x 109/ L it is recommended to administer prednisone/ prednisolone 100 mg intravenous shortly before infusion with MabThera to decrease the rate and severity of acute infusion reactions and/ or cytokine release syndrome.
3 100 mg prednisone/ prednisolone fil- vini eżatt qabel infużjoni b’ MabThera biex titnaqqas ir- rata u s - severità ta ’ reazzjonijiet akuti għall- infużjoni u/ jew is- sindrome tar- reħa taċ- ċitokina.
3 The recommended dosage of MabThera in combination with chemotherapy is 375 mg/ m2 body surface area administered on day 1 of the first treatment cycle followed by 500 mg/ m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Id- dożaġġ irrakkomandata ta ’ MabThera flimkien ma ’ kimoterapija huwa 375 mg/ m2 ta ’ erja tas - superfiċje tal- ġisem mogħti fl- ewwel ġurnata ta ’ l- ewwel ċiklu ta ’ kura segwit minn 500 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem mogħti fl- ewwel ġurnata ta ’ kull ċiklu sussegwenti għal total ta ’ 6 ċikli.
The chemotherapy should be given after MabThera infusion.
Il - kimoterapija għandha tingħata wara infużjoni ta ’ MabThera.