qanastek/EMEA-V3 huggingface dataset:
A course of MabThera consists of two 1000 mg intravenous infusions.
Kors ta ’ MabThera jikkonsisti minn żewġ infużjonijiet fil- vini ta ’ 1000 mg.
The recommended dosage of MabThera is 1000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
Id- doża rrakkomandata ta ’ MabThera hija ta ’ 1000 mg permezz ta ’ infużjoni fil- vini segwita minn infużjoni fil- vini oħra ta ’ 1000 mg ġimagħtejn wara.
Disease activity should be regularly monitored.
L- attività tal- marda għandha tiġi mmonitorjata b’ mod regolari.
There are limited clinical data on the safety and efficacy of further courses of therapy with MabThera.
Teżisti dejta klinika limitata dwar is - sigurtà u l- effikaċja ta ’ aktar korsijiet ta ’ terapija b’ MabThera.
In a small observational cohort, approximately 600 patients with evidence of continued disease activity received 2-5 repeated courses of treatment 6- 12 months after the previous course.
Fi grupp ta ’ osservazzjoni żgħir, madwar 600 pazjent b’ evidenza ta ’ attività kontinwa tal- marda rċevew 2- 5 korsijiet ripetuti ta ’ kura 6 - 12- il xahar wara l- kors preċedenti.
(See sections 4.8 and 5.1).
(Ara sezzjoni 4. 8 u 5. 1).
Human anti chimeric antibodies (HACA) develop in some patients after the first course of MabThera (see section 5.1).
Antikorpi antikimeriċi umani (HACA – human anti chimeric antibodies) jiżviluppaw f’ xi pazjent wara l- ewwel kors ta ’ MabThera (ara sezzjoni 5. 1).
The presence of HACA may be associated with the worsening of infusion or allergic reactions after the second infusion of subsequent courses.
Il- preżenza ta ’ HACA tista ’ tkun assoċjata mat- taħżin tar- reazzjonijiet għall- infużjoni jew allerġiċi wara t- tieni infużjoni ta ’ korsijiet suċċessivi.
Furthermore, in one case with HACA, failure to deplete B-cells after receipt of further treatment courses has been observed.
Barraminhekk, f’ każ wieħed b’ HACA, kien osservat falliment li jitnaqqsu ċ- ċelluli B wara r - riċeviment ta ’ aktar korsijiet ta ’ kura.
Thus, the benefit/ risk balance of therapy with MabThera should be carefully considered before administering subsequent courses of Mabthera.
Għalhekk, il- bilanċ bejn il- vantaġġ u r- riskju ta ’ terapija b’ MabThera għandu jiġi kkunsidrat sewwa qabel ma jingħataw korsijiet suċċessivi ta ’ MabThera.
If a repeat course of treatment is considered it should not be given at an interval less than 16 weeks.
Jekk jiġi kkunsidrat kors ripetut ta ’ kura, dan m’ għandux jingħata f’ intervall ta ’ anqas minn 16- il ġimgħa.
Background therapy with glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with MabThera.
It- terapija ta ’ sfond bi glukokortikojdi, saliċilati, mediċini anti- infjammatorji mhux sterojds, jew analġeżiċi tista ’ titkompla matul il- kura b’ MabThera.
Rheumatoid arthritis patients should receive treatment with 100 mg intravenous methylprednisolone 30 minutes prior to MabThera to decrease the rate and severity of acute infusion reactions (see method of administration).
Pazjenti b’ artrite rewmatika għandhom jirċievu kura b’ 100 mg methylprednisolone fil- vini 30 minuta qabel MabThera sabiex titnaqqas ir- rata u s- severità tar- reazzjonijiet akuti għall- infużjoni (ara l - metodu ta ’ kif jingħata).
First infusion of each course The recommended initial rate for infusion is 50 mg/ hr; after the first 30 minutes, it can be escalated in 50 mg/ hr increments every 30 minutes, to a maximum of 400 mg/ hr.
L- ewwel infużjoni ta ’ kull kors Ir- rata inizjali rakkomandata għall- infużjoni hija ta ’ 50 mg/ siegħa; wara l- ewwel 30 minuta, din tista ’ tiżdied f’ inkrementi ta ’ 50 mg/ siegħa kull 30 minuta, sa massimu ta ’ 400 mg/ siegħa.
Second infusion of each course Subsequent doses of MabThera can be infused at an initial rate of 100 mg/ hr, and increased by 100 mg/ hr increments at 30 minutes intervals, to a maximum of 400 mg/ hr.
It- tieni infużjoni ta ’ kull kors Dożi sussegwenti ta ’ MabThera jistgħu jiġu infużi b’ rata inizjali ta ’ 100 mg/ siegħa, u jiżdiedu b’ inkrementi ta ’ 100 mg/ siegħa f’ intervalli ta ’ 30 minuta, sa massimu ta ’ 400 mg/ siegħa.
Paediatric use MabThera is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Użu fit- tfal MabThera mhux irrakkomandat għall- użu fit- tfal u l- adoloxxenti peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Elderly No dose adjustment is required in elderly patients (aged > 65 years).
Anzjani M’ hemmx bżonn ta ’ aġġustament fid- doża f’ pazjenti anzjani (età > 65 sena).
Method of Administration Premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy for treatment of non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia.
Metodu ta ’ l- Għoti Jekk MabThera ma jingħatax flimkien ma ’ kimoterapija li fiha l- glukokortikojdi għandha tiġi kkunsidrata medikazzjoni minn qabel bil- glukokortikojdi għall- kura ta ’ limfoma mhux ta ’ Hodgkin u ta ’ lewkimja limfoċitika kronika.
Premedication consisting of an anti-pyretic and an antihistaminic, e. g. paracetamol and diphenhydramine, should always be administered before each infusion of MabThera.
Medikazzjoni minn qabel li tikkonsisti minn mediċina kontra d- deni u antistaminiku, e. ż. paracetamol u diphenhydramine, għandha dejjem tingħata qabel kull infużjoni ta ’ MabThera.
First infusion The recommended initial rate for infusion is 50 mg/ hr; after the first 30 minutes, it can be escalated in 50 mg/ hr increments every 30 minutes, to a maximum of 400 mg/ hr.
4 L- ewwel infużjoni Ir- rata inizjali rrakkomandata għall- infużjoni hija ta ’ 50 mg/ siegħa; wara l- ewwel 30 minuta, din tista ’ tiżdied f’ żjidiet ta ’ 50 mg/ siegħa kull 30 minuta, sa massimu ta ’ 400 mg/ siegħa.
4 Subsequent infusions Subsequent doses of MabThera can be infused at an initial rate of 100 mg/ hr, and increased by 100 mg/ hr increments at 30 minutes intervals, to a maximum of 400 mg/ hr.
Infużjonijiet sussegwenti Dożi sussegwenti ta ’ MabThera jistgħu jiġu infużi b’ rata inizjali ta ’ 100 mg/ siegħa, u miżjuda b’ żjidiet ta ’ 100 mg/ siegħa f’ intervalli ta ’ 30 minuta, sa massimu ta ’ 400 mg/ siegħa.
The prepared MabThera solution should be administered as an intravenous infusion through a dedicated line.
Is- soluzzjoni ppreparata ta ’ MabThera għandha tingħata bħala infużjoni fil- vina permezz ta ’ pajp separat.
It should not be administered as an intravenous push or bolus.
M’ għandiex tingħata bħala push jew bolus fil- vini.
Patients should be closely monitored for the onset of cytokine release syndrome (see section 4.4).
Il- pazjenti għandhom jiġu monitorati mill- qrib għad- dehra tas- sindrome tar- reħa taċ- ċitokina (ara sezzjoni 4. 4).
Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately.
Pazjenti li jiżviluppaw evidenza ta ’ reazzjonijiet severi, speċjalment qtugħ ta ’ nifs sever, bronkospażmu jew ipoxja għandu jkollhom l- infużjoni imwaqqfa immedjatament.
Patients with non-Hodgkin’ s lymphoma should then be evaluated for evidence of tumour lysis syndrome including appropriate laboratory tests and, for pulmonary infiltration, with a chest x-ray.
Pazjenti b’ limfoma mhux ta ’ Hodgkin imbagħad għandhom jiġu evalwati għall- evidenza tas- sindrome tal- lisi tat- tumur inkluż testijiet tal- laboratorju xierqa, u għall- infiltrati pulmonari, b’ x- ray tas- sider.
In all patients, the infusion should not be restarted until complete resolution of all symptoms, and normalisation of laboratory values and chest x-ray findings.
Fil- pazjenti kollha, l- infużjoni m’ għandhiex tissokta mill- ġdid qabel is- sintomi kollha jgħaddu għal kollox, u l- valuri tal - laboratorju u s- sejbiet ta ’ l- x- ray tas- sider jirritornaw għan- normal.
At this time, the infusion can be initially resumed at not more than one-half the previous rate.
F’ dan iż- żmien l- infużjoni tista ’ tissokta mill- ġdid, inizjalment b’ mhux aktar minn nofs ir- rata preċedenti.
If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis.
Jekk l- istess reazzjonijiet avversi severi jerġgħu jseħħu għat- tieni darba, għandha tiġi kkunsidrata serjament id- deċiżjoni li titwaqqaf il- kura, skond il- każ.
Mild or moderate infusion-related reactions (section 4.8) usually respond to a reduction in the rate of infusion.
Reazzjonijiet ħfief jew moderati relatati ma ’ l- infużjoni (sezzjoni 4. 8) ġeneralment jirrispondu għal tnaqqis fir- rata ta ’ l- infużjoni.
The infusion rate may be increased upon improvement of symptoms.
Kif jitjiebu s- sintomi, r- rata ta ’ l- infużjoni tista ’ tiġi miżjuda.
Contraindications for use in non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia
Kontra- indikazzjonijiet għall- użu f’ limfoma mhux ta ’ Hodgkin u lewkimja limfoċitika kronika
Hypersensitivity to the active substance or to any of the excipients or to murine proteins.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi jew għall- proteini tal - ġrieden.
Active, severe infections (see section 4.4).
Infezzjonijiet attivi, severi (ara sezzjoni 4. 4).
Contraindications for use in rheumatoid arthritis
Kontra- indikazzjonijiet għall- użu f’ artrite rewmatika
Active, severe infections (see section 4.4).
Infezzjonijiet severi, attivi (ara sezzjoni 4. 4).
Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease.
Insuffiċjenza severa tal- qalb (New York Heart Association Klassi IV) jew mard tal- qalb serju, mhux ikkontrollat.
Progressive Multifocal Leukoencephalopathy
Lewkoenċefalopatija Multifokali Progressiva
Use of MabThera maybe associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML).
L- użu ta ’ MabThera jista ’ jkun assoċjat ma ’ riskju miżjud ta ’ Lewkoenċefalopatija Multifokali Progressiva (PML).
Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML.
Il- pazjenti għandhom jiġu sorveljati f’ intervalli regolari għal kull sinjal jew sintomu newroloġiku ġdid jew li rkada li jista ’ jissuġġerixxi PML.
If PML is suspected, further dosing must be suspended until PML has been excluded.
Jekk PML tkun issuspettata, aktar dożaġg għandu jitwaqqaf sakemm PML tiġi eskluża.
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
It- tabib għandu jivvaluta l- pazjent biex jiddetermina jekk is- sintomi humiex indikattivi ta ’ funzjoni newroloġika ħażina, u jekk ikun il- każ, jekk dawn is- sintomi humiex qed jissuġġerixxu possibiltà ta ’ PML.
Consultation with a Neurologist should be considered as clinically indicated.
Konsultazzjoni ma ’ Newrologu għandha tiġi kkunsidrata bħala klinikament indikata.
If any doubt exists, further evaluation, including MRI scan preferably with contrast, CSF testing for JC Viral DNA and repeat neurological assessments, should be considered.
Jekk ikun hemm xi dubju, għandhom jiġu kkunsidrati aktar valutazzjonijiet, inkluż scan ta ’ l- MRI preferibilment b’ kuntrast, ittestjar tas- CSF għal DNA JC Virali u valutazzjonijiet newroloġiċi ripetuti.
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e. g. cognitive, neurological or psychiatric symptoms).
5 It- tabib għandu joqgħod attent b’ mod partikolari għal sintomi li jissuġġerixxu PML li l- pazjent jista ’ ma jinnutax (e. ż. sintomi konoxxittivi, newroloġiċi jew psikjatriċi).
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Il- pazjenti għandhom jiġu avżati wkoll biex jinfurmaw lis- sieħeb/ sieħba tagħhom jew dawk li qed jieħdu ħsiebhom dwar il- kura tagħhom, peress li dawn jistgħu jinnutaw sintomi li l- pazjent ma jkunx jaf bihom.
If a patient develops PML the dosing of MabThera must be permanently discontinued.
Jekk il- pazjent jiżviluppa PML id- dożaġġ ta ’ MabThera għandu jitwaqqaf għal kollox.
5 Following reconstitution of the immune system in immunocompromised patients with PML, stabilisation or improved outcome has been seen.
Wara r- rikostituzzjoni tas- sistema immuni f’ pazjenti immunokompromessi b’ PML, kien osservat stabilizzazzjoni jew titjib fir- riżultat.
It remains unknown if early detection of PML and suspension of MabThera therapy may lead to similar stabilisation or improved outcome.
Għadu mhux magħruf jekk identifikazzjoni bikrija ta ’ PML u sospensjoni ta ’ terapija b’ MabThera jistax iwwassal għal stabilizzazzjoni jew titjib simili tar- riżultat.
Non-Hogkin’ s lymphoma and chronic lymphocytic leukaemia
Limfoma mhux ta ’ Hodgkin u lewkimja limfoċitika kronika
Patients with a high tumour burden or with a high number (≥ 25 x 109/ l) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should only be treated with extreme caution.
Pazjenti b’ piż ta ’ tumur għoli jew b’ numru għoli (≥25 x 109/ l) ta ’ ċelluli malinni fiċ- ċirkulazzjoni bħal pazjenti b’ CLL, li jistgħu jkunu f’ riskju akbar ta ’ sindrome tar- reħa taċ- ċitokina gravi b’ mod speċjali, għandhom jiġu trattati biss jekk b’ attenzjoni estrema.
These patients should be very closely monitored throughout the first infusion.
Dawn il- pazjenti għandhom ikunu monitorati mill- qrib ħafna matul l- ewwel infużjoni.
Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle.
Għall- ewwel infużjoni f’ dawn il- pazjenti għandu jiġi kkunsidrat l- użu ta ’ rata ta ’ infużjoni mnaqqsa jew dożaġġ maqsum fuq jumejn waqt l- ewwel ċiklu.
Severe cytokine release syndrome is characterised by severe dyspnea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema.
Is- sindrome tar- reħa taċ- ċitokina hija kkaratterizzata minn dispnea severa, spiss akkumpanjata minn bronkospażmi u ipossija, flimkien mad- deni, irjiħat, rogħda, urtikarja, u anġjoedima.
This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphaetemia, acute renal failure, elevated Lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Din is- sindrome tista ’ tiġi assoċjata ma ’ xi karatteristiċi tas- sindrome tal- lisi tat- tumur bħall- iperuriċemija, iperkalimja, ipokalċimja, iperfosfatimja, insuffiċjenza akuta tal- kliewi, Lactate dehydrogenase (LDH) elevat u jista ’ jkun assoċjat mal- kollass respiratorju akut u l- mewt.
The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray.
Il- kollass respiratorju akut jista ’ jkun akkompanjat minn episodji bħall- infiltrazzjoni interstizjali pulmonari jew edima, li jkunu jidhru fuq raġġi X tas- sider.
The syndrome frequently manifests itself within one or two hours of initiating the first infusion.
Is- sindrome spiss tidher fi żmien siegħa jew sagħtejn mill- ewwel infużjoni.
Patients with a history of pulmonary insufficiency or those with pulmonary tumour infiltration may be at greater risk of poor outcome and should be treated with increased caution.
Pazjenti b’ passat ta ’ insuffiċjenza pulmonari jew dawk b’ infiltrazzjoni ta ’ tumur pulmonari jistgħu jkunu f’ riskju akbar ta ’ riżultat fqir u għandhom jiġu trattati b’ aktar attenzjoni.
Patients who develop severe cytokine release syndrome should have their infusion interrupted immediately (see section 4.2) and should receive aggressive symptomatic treatment.
Għal pazjenti li jiżviluppaw sindrome tar- reħa ta ’ ċitokina gravi l- infużjoni għandha tiġi interrotta immedjatament (ara sezzjoni 4. 2) u għandhom jingħataw kura sintomatika aggressiva.
Since initial improvement of clinical symptoms may be followed by deterioration, these patients should be closely monitored until tumour lysis syndrome and pulmonary infiltration have been resolved or ruled out.
Minħabba li t- titjib inizjali ta ’ sintomi kliniċi jista ’ jkun segwit minn deterjorament, dawn il- pazjenti għandhom ikunu monitorati mill- qrib sakemm is- sindrome tal- lisi tat- tumur u l- infiltrazzjoni pulmonari jkunu ġew riżolti jew eliminati.
Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
Aktar kura wara li s- sinjali u s- sintomi tal- pazjenti ma jibqgħux evidenti rari rriżultat f’ sindrome tar- reħa taċ - ċitokina gravi.
Infusion related adverse reactions including cytokine release syndrome (see section 4.8) accompanied by hypotension and bronchospasm have been observed in 10% of patients treated with MabThera.
Reazzjonijiet avversi li għandhom x’ jaqsmu ma ’ l- infużjoni, inkluż is- sindrome tar - reħa taċ- ċitokina (ara sezzjoni 4. 8) flimkien ma ’ pressjoni baxxa u bronkospażmi ġew osservati f’ 10% tal- pazjenti trattati b’ MabThera.
These symptoms are usually reversible with interruption of MabThera infusion and administration of an anti-pyretic, an antihistaminic, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Dawn is- sintomi huma ġeneralment riversibbli bl- interruzzjoni ta ’ l - infużjoni ta ’ MabThera u l- amministrazzjoni ta ’ mediċina kontra d- deni, antistamina, u, xi kultant, ossiġnu, soluzzjoni ta ’ melħ fil- vini jew bronkodilaturi, u glukokortikojdi jekk meħtieġ.
Please see cytokine release syndrome above for severe reactions.
Jekk jogħġbok ara s- sindrome tar- reħa taċ- ċitokina hawn fuq għal reazzjonijiet severi.
Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins to patients.
Wara l- amministrazzjoni fil- vini ta ’ proteini lill- pazjenti ġew irrapportati reazzjonijiet anafilattiċi u reazzjonijiet oħrajn ta ’ sensittività eċċessiva.
In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
B’ kuntrast mas- sindrome tar- reħa taċ- ċitokina, reazzjonijiet ta ’ sensittività eċċessiva veri tipikament jidhru f’ temp ta ’ minuti wara l- bidu ta ’ l - infużjoni.
Medicinal products for the treatment of hypersensitivity reactions, e. g., epinephrine (adrenaline), antihistamines and glucocorticooids, should be available for immediate use in the event of an allergic reaction during administration of MabThera.
Għandhom ikunu disponibbli għall- użu immedjat prodotti mediċinali għall- kura ta ’ reazzjonijiet ta ’ sensittività eċċessiva, eż. epinefrina (adrenalina), antiħistamini u glukokortikojdi, f’ każ li jkun hemm reazzjoni allerġika waqt l- amministrazzjoni ta ’ MabThera.
Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Manifestazzjonijiet kliniċi ta ’ anafilassi jistgħu jidhru simili għal manifestazzjonijiet tas- sindrome tar- reħa taċ- ċitokina (deskritt aktar ‘ il fuq).
Reactions attributed to hypersensitivity have been reported less frequently than those attributed to cytokine release.
Reazzjonijiet attribwiti għas- sensittività eċċessiva kienu rrapportati inqas spiss minn dawk attribwiti għar- reħa taċ- ċitokina.
Since hypotension may occur during MabThera infusion, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the MabThera infusion.
Minħabba li jista ’ jkun hemm pressjoni baxxa waqt l- infużjoni ta ’ MabThera, għandha tiġi kkunsidrata l- possibilità li jitwaqqfu l- mediċini ta ’ kontra l- pressjoni għolja 12- il siegħa qabel l- infużjoni ta ’ MabThera.
Angina pectoris, or cardiac arrhythmias such as atrial flutter and fibrillation heart failure or myocardial infarction have occurred in patients treated with MabThera.
6 Anġina pektoris, jew arritmija kardijaka bħal kollass tal- qalb minħabba taħbit u fibrillazzjoni atrijali jew infart mijokardijaku dehru f’ pazjenti trattati b’ MabThera.
Therefore patients with a history of cardiac disease and/ or cardiotoxic chemotherapy should be monitored closely.
Għaldaqstant pazjenti b’ passat ta ’ mard tal- qalb u/ jew kimoterapija kardjotossika għandhom ikunu monitorati mill- qrib.
Although MabThera is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/ l and/ or platelet counts < 75 x 109/ l as clinical experience in this population is limited.
Għalkemm MabThera mhux mijelosuppressiv fil- monoterapija, għandha tingħata attenzjoni meta tiġi kkunsidrata l- kura ta ’ pazjenti bin- newtrofils < 1. 5 x 109/ l u/ jew għadd platelet < 75 x 109/ l, minħabba li l- esperjenza klinika f’ din il- popolazzjoni hija limitata.
MabThera has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
MabThera ġie użat fuq 21 pazjent li għaddew minn trapjant awtologu tal- mudullun ta ’ l- għadam u gruppi f’ riskju oħrajn bil- funzjoni tal- mudullun presubilment imnaqqsa mingħajr effetti ta ’ mijelotossiċità.
6 Consideration should be given to the need for regular full blood counts, including platelet counts, during monotherapy with MabThera.
Għandha tingħata attenzjoni għall- bżonn tat- teħid regolari tad- demm, inkluż l- għadd platelet, waqt il - monoterapija b’ MabThera.
When MabThera is given in combination with CHOP or CVP (cyclophosphamide, vincristine, and prednisone) chemotherapy, regular full blood counts should be performed according to usual medical practice.
Meta MabThera tingħata flimkien ma ’ kimoterapija CHOP jew CVP (cyclophosphamide, vincristine, u prednisone), għandu jittieħed id- demm regolarment skond il - prattika medika ġenerali.
Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Waqt terapija b’ MabThera jista ’ jkun hemm infezzjonijiet severi, inkluż fatalitajiet (ara sezzjoni 4. 8).
MabThera should not be administered to patients with an active and/ or severe infection (e. g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
MabThera m’ għandux jingħata lill- pazjenti b’ infezzjoni attiva u/ jew severa (eż. tuberkulosi, sepsi u infezzjonijiet opportunistiċi, ara sezzjoni 4. 3).
Physicians should exercise caution when considering the use of MabThera in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
It- tobba għandhom jużaw kawtela meta jikkunsidraw l- użu ta ’ MabThera f’ pazjenti b’ passat ta ’ infezzjonijiet li jerġgħu jitfaċċaw jew kroniċi jew b’ kundizzjonijiet eżistenti li jistgħu jippredisponu aktar lill- pazjenti għall- infezzjoni serja (ara sezzjoni 4. 8).
Very rare cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
F’ individwi li kienu qed jirċievu rituximab kienu rrapportati każijiet rari ħafna ta ’ riattivazzjoni ta ’ epatite B, inkluż epatite fulminanti b’ riżultat fatali.
The majority of these subjects were also exposed to cytotoxic chemotherapy.
Il- biċċa l- kbira ta ’ dawn is- suġġetti kienu esposti wkoll għal kimoterapija ċitotossika.
The reports are confounded by both the underlying disease state and the cytotoxic chemotherapy.
Ir- rapporti huma konfużi kemm mill- istat tal- marda bażika u l - kimoterapija ċitotossika.
Patients with a history of hepatitis B infection should be carefully monitored for signs of active hepatitis B infection when rituximab is used in association with cytotoxic chemotherapy.
Il- pazjenti bi storja ta ’ infezzjoni ta ’ l- epatite B għandhom jiġu mmonitorjati bir- reqqa għal sinjali ta ’ infezzjoni attiva ta ’ l- epatite B meta rituximab jintuża flimkien ma ’ kimoterapija ċitotossika.
Very rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported during post-marketing use of MabThera in NHL and CLL (see section 4.8).
Każijiet rari ħafna ta ’ Lewkoenċefalopatija Multifokali Progressiva (PML) kienu rrapportati waqt l - użu ta ’ wara t- tqegħid fis- suq ta ’ MabThera f’ NHL u CLL (ara sezzjoni 4. 8).
The majority of patients had received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Il- maġġoranza ta ’ pazjenti kienu rċevew rituximab flimkien ma ’ kimoterapija jew bħala parti minn trapjant ematopoetiku ta ’ ċelluli staminali.
The safety of immunization with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Is- sigurtà ta ’ tilqim b’ vaċċini virali ħajjin, wara terapija b’ MabThera ma ġietx studjata għall- pazjenti b’ NHL u CLL u tilqim b’ vaċċini virali ħajjin mhux irrakkomandata.
Patients treated with MabThera may receive non-live vaccinations.
Pazjenti kkurati b’ MabThera jistgħu jirċievu tilqim mhux ħaj.
However with non-live vaccines response rates may be reduced.
Madankollu, ir- rati ta ’ rispons b’ vaċċini mhux ħajjin jistgħu jkunu mnaqqsa.
In a non-randomized study, patients with relapsed low-grade NHL who received MabThera monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs.
Fi studju mhux randomised, pazjenti b’ NHL ta ’ grad baxx li rkadat li rċevew monoterapija ta ’ MabThera meta mqabbel ma ’ kontrolli b’ saħħithom mhux ikkurati kellhom rata ta ’ rispons aktar baxxa għal tilqim b’ tetanus recall antigen (16% vs.
81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs.
81%) u b’ Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs.
69% when assessed for > 2-fold increase in antibody titer).
69% meta stmat għal żjieda ta ’ > darbtejn fit- titer ta ’ l- antikorp).
For CLL patients similar results are assumable considering similarities between both diseases but that has not been investigated in clinical trials.
Għall- pazjenti b’ CLL huma mistennija riżultati simili meta jiġu kkunsidrati similaritajiet bejn iż- żewġ mardiet iżda dan ma ġiex investigat fi provi kliniċi.
Mean pre-therapeutic antibody titers against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
Il- medja tat- titri ta ’ qabel it- terapija kontra sensiela ta ’ antigens (Streptococcus pneumoniae, influwenza A, ħosba, rubella, varicella) inżammu għal ta ’ l- inqas 6 xhur wara kura b’ MabThera.
Infusion reactions MabThera is associated with infusion reactions, which may be related to release of cytokines and/ or other chemical mediators.
Reazzjonijiet għall- infużjoni MabThera huwa assoċjat ma ’ reazzjonijiet għall- infużjoni, li jistgħu jkunu relatati mar- reħa ta ’ ċitokini u/ jew medjaturi kimiċi oħra.
Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of these events (see section 4.8).
Medikazzjoni minn qabel bi glukokortikojdi fil- vini naqqset b’ mod sinifikanti l- inċidenza u s- severità ta ’ dawn l- episodji (ara sezzjoni 4. 8).
Most infusion events reported were mild to moderate in severity.
Il- biċċa l- kbira ta ’ l- episodji ta ’ l- infużjoni rrapportati kienu ta ’ severità ħafifa għal moderata.
The proportion of affected patients decreases with subsequent infusions.
Il - proporzjon tal- pazjenti affettwati jonqos ma ’ infużjonijiet sussegwenti.
The reactions reported were usually reversible with a reduction in rate, or interruption, of MabThera infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
7 amministrazzjoni ta ’ mediċina kontra d- deni, antiħistamina, u kultant, ossiġnu, soluzzjoni ta ’ melħ fil - vini jew bronkodilaturi, u glukokortikojdi jekk meħtieġ.
In most cases, the infusion can be resumed at a 50% reduction in rate (e. g. from 100 mg/ h to 50 mg/ h) when symptoms have completely resolved.
Fil- maġġoranza tal- każi, l- infużjoni tista ’ titkompla bi tnaqqis ta ’ 50% fir- rata (jiġifieri minn 100 mg/ siegħa għal 50 mg/ siegħa) meta s- sintomi jkunu għebu għalkollox.
Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins, including MabThera, to patients.
Reazzjonijiet anafilattiċi u reazzjonijiet oħra ta ’ sensittività eċċessiva kienu rrapportati wara l- għoti fil - vini ta ’ proteini, fosthom MabThera, lil pazjenti.
Medicinal products for the treatment of hypersensitivity reactions, e. g., epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of MabThera.
Għandhom ikunu disponibbli għall- użu immedjat prodotti mediċinali għall- kura ta ’ reazzjonijiet ta ’ sensittività eċċessiva, eż. epinefrina (adrenalina), antistamini u glukokortikojdi, f’ każ li jkun hemm reazzjoni allerġika waqt l- amministrazzjoni ta ’ MabThera.
The presence of HACA may be associated with worsening infusion or allergic reactions after the second infusion of subsequent courses (see section 5.1).
Il- preżenza ta ’ HACA tista ’ tkun assoċjata mat- taħżin tar- reazzjonijiet għall- infużjoni jew allerġiċi wara t- tieni infużjoni ta ’ korsijiet suċċessivi (ara sezzjoni 5. 1).
7 In clinical studies 10/ 990 (1%) patients with rheumatoid arthritis who received a first infusion of MabThera at any dose experienced a serious reaction during the infusion (see section 4.8).
Fi studji kliniċi 10/ 990 (1%) pazjent b’ artrite rewmatika li rċevew l- ewwel infużjoni ta ’ MabThera fi kwalunkwe doża esperjenzaw reazzjoni serja matul l- infużjoni (ara sezzjoni 4. 8).
There are no data on the safety of MabThera in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
M’ hemmx informazzjoni dwar is- sigurtà ta ’ MabThera f’ pazjenti b’ insuffiċjenza tal- qalb moderata (NYHA klassi III) jew mard kardjovaskulari serju, mhux ikkontrollat.
In patients treated with MabThera, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Fil- pazjenti kkurati b’ MabThera, l- okkorrenza ta ’ kundizzjonijiet tal- qalb iskemiċi diġà eżistenti li jsiru sintomatiċi, bħal anġina pectoris, kienet osservata, l- istess bħall- fibrillazzjoni atrijali u t- taħbit tal- qalb irregolari.
Therefore, in patients with a known cardiac history, the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with MabThera and patients closely monitored during administration.
Għalhekk, f’ pazjenti bi storja kardijaka magħrufa, ir- riskju ta ’ kumplikazzjonijiet kardjovaskulari li jirriżultaw mir- reazzjonijiet għall- infużjoni għandhom jiġu kkunsidrati qabel il- kura b’ MabThera u l- pazjenti jiġu mmonitorjati mill- viċin waqt l- għoti.
Since hypotension may occur during MabThera infusion, consideration should be given to withholding anti-hypertensive medications 12 hours prior to the MabThera infusion.
Minħabba li jista ’ jkun hemm pressjoni baxxa waqt l- infużjoni ta ’ MabThera, għandha tiġi kkunsidrata l- possibilità li jitwaqqfu l- medikazzjonijiet ta ’ kontra l - pressjoni għolja 12- il siegħa qabel l- infużjoni ta ’ MabThera.
Infections Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Infezzjonijiet Infezzjonijiet serji, fosthom fatalitajiet, jistgħu jseħħu waqt terapija b’ MabThera (ara sezzjoni 4. 8).
MabThera should not be administered to patients with an active and/ or severe infection (e. g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e. g. in hypogammaglobulinemia or where levels of CD4 or CD8 are very low).
MabThera m’ għandux jingħata lil pazjenti b’ infezzjoni attiva u/ jew severa (eż. tuberkulożi, sepsis u infezzjonijiet opportunistiċi, ara sezzjoni 4. 3) jew pazjenti immunokompromessi severament (eż. f’ ipogammaglobulinemija jew fejn il- livelli ta ’ CD4 jew CD8 ikunu baxxi ħafna).
Physicians should exercise caution when considering the use of MabThera in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
It- tobba għandhom jużaw kawtela meta jikkunsidraw l- użu ta ’ MabThera f’ pazjenti bi storja ta ’ infezzjonijiet rikorrenti jew kroniċi jew b’ kundizzjonijiet bażiċi li jistgħu jippredisponu aktar lill- pazjenti għal infezzjoni serja (ara sezzjoni 4. 8).
Patients reporting signs and symptoms of infection following MabThera therapy should be promptly evaluated and treated appropriately.
Il- pazjenti li jirrappurtaw sinjali u sintomi ta ’ infezzjoni wara terapija b’ MabThera għandhom jiġu evalwati mill- ewwel u ttrattati b’ mod xieraq.
Before giving a subsequent course of MabThera treatment, patients should be re-evaluated for any potential risk for infections.
Qabel ma jingħataw kors suċċessiv ta ’ kura b’ MabThera, il- pazjenti għandhom jiġu evalwati mill- ġdid għal kwalunkwe riskju potenzjali ta ’ infezzjonijiet.
Very rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported following use of MabThera for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and Vasculitis.
Wara l- użu ta ’ MabThera għall- kura ta ’ artrite rewmatika u mard awtoimmuni inkluż Lupus Eritematosus Sistemika (SLE) u Vaskulite kienu irrapportati każijiet tari ħafna ta ’ Lewkoenċefalopatija Multifokali Progressiva (PML).
These cases involved patients with multiple risk factors for PML, including the underlying disease and long-term immunosuppressive therapy or chemotherapy.
Dawn il- każijiet kienu jinvolvu pazjenti b’ diversi fatturi ta ’ riskju għal PML, inkluż l- marda li hemm preżenti u terapija immunosoppressiva fit- tul jew kimoterapija.
In patients with non-Hodgkin’ s lymphoma receiving rituximab in combination with cytotoxic chemotherapy, very rare cases of hepatitis B reactivation have been reported (see non-Hodgkin’ s lymphoma).
F’ pazjenti b’ limfoma mhux ta ’ Hodgkin li rċevew rituximab flimkien ma ’ kimoterapija ċitotossika, ġew irrapportati każijiet rari ħafna ta ’ riattivazzjoni ta ’ l- epatite B (ara limfoma mhux ta ’ Hodgkin).
Immunization Physicians should review the patient’ s vaccination status and follow current immunization guidelines prior to MabThera therapy.
Tilqim It- tobba għandhom jirrevedu l- istat ta ’ tilqim tal- pazjent u jsegwu l- linji gwida ta ’ tilqim qabel terapija b’ MabThera.
Vaccination should be completed at least 4 weeks prior to first administration of MabThera.
It- tilqim għandu jitkompla ta ’ l- inqas 4 ġimgħat qabel l- ewwel għoti ta ’ MabThera.
The safety of immunization with live viral vaccines following MabThera therapy has not been studied.
Is- sigurtà ta ’ tilqim b’ vaċċini virali ħajjin wara terapija b’ MabThera ma ġietx studjata.
Therefore vaccination with live virus vaccines is not recommended whilst on MabThera or whilst peripherally B cell depleted.
Għalhekk tilqim b’ vaċċini ħajjin mhux irrakkomandat waqt terapija b’ MabThera jew waqt tnaqqis ta ’ ċelluli B fil- periferiji.
However, response rates to non- live vaccines may be reduced.
Madankollu, r- rati ta ’ rispons għall - vaċċini mhux ħajjin jistgħu jkunu mnaqqsa.
In a randomized study, patients with RA treated with MabThera and methotrexate had comparable response rates to tetanus recall antigen (39% vs.
Fi studju randomised, pazjenti b’ RA kkurati b’ MabThera u methotrexate kellhom rati ta ’ rispons komparabbli għat- tetanus recall antigen (39% vs.
42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs.
42%), u rati
82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs.
8 mnaqqsa għall- vaċċin ta ’ polysaccharide pnewmokokkali (43% vs 82% għal ta ’ l- inqas żewġ serotipi ta ’ antikorpi pnewmokokkali), u KLH neoantigen (47% vs.
93%), when given 6 months after MabThera/ Rituxan as compared to patients only receiving methotrexate.
93%), meta mogħtija 6 xhur wara MabThera meta mqabbel ma pazjenti li rċevew methotrexate biss.
Should non-live vaccinations be required whilst receiving MabThera therapy, these should be completed at least 4 weeks prior to commencing the next course of MabThera
Jekk waqt terapija b’ MabThera hemm il- ħtieġa ta ’ tilqim mhux ħaj, dawn għandhom jitkomplew ta ’ l- inqas 4 ġimgħat qabel il- bidu tal- kors li jmiss ta ’ MabThera
In the overall experience of MabThera repeat treatment over one year, the proportions of patients with positive antibody titers against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Fl- esperjenza globali ta ’ kura ripetuta ta ’ MabThera fuq medda ta ’ sena, il- proporzjon ta ’ pazjenti b’ titri ta ’ antikorpi pożittivi kontra tossojdi ta ’ S. pneumoniae, influwenza, ħosba, rubella, varicella u tetanus ġeneralment kienu simili għall- proporzjonijiet fil- linja bażi.
8 Concomitant/ sequential use of other DMARDs The concomitant use of MabThera and antirheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Użu konkomitanti/ sekwenzjali ta ’ DMARDs oħra L- użu konkomitanti ta ’ MabThera u terapiji anti- rewmatiċi għajr dawk speċifikati taħt l- indikazzjoni u l- pożoloġija għall- artrite rewmatika mhux rakkomandat.
There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).
Hemm tagħrif limitat mill- provi kliniċi biex tkun evalwata b’ mod sħiħ is- sigurtà ta ’ l- użu sekwenzjali ta ’ DMARDs oħra (inkluż inibituri TNF u bijoloġiċi oħra) wara MabThera (ara sezzjoni 4. 5).
The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with MabThera, however patients should be closely observed for signs of infection if biologic agents and/ or DMARDs are used following MabThera therapy.
It- tagħrif disponibbli jindika li r- rata ta ’ infezzjoni ta ’ rilevanza klinika ma tinbidilx meta terapiji bħal dawn jintużaw f’ pazjenti kkurati minn qabel b’ MabThera, madankollu l- pazjenti għandhom jiġu osservati b’ attenzjoni għal sinjali ta ’ infezzjoni jekk jintużaw sustanzi bijoloġiċi u/ jew DMARDs wara terapija b’ MabThera.
Malignancy Immunomodulatory drugs may increase the risk of malignancy.
Tumuri malinni Il- mediċini immunomodulatorji jistgħu jżidu r- riskju ta ’ tumuri malinni.
On the basis of limited experience with MabThera in rheumatoid arthritis patients (see section 4.8) a possible risk for the development of solid tumours cannot be excluded at this time, although present data do not seem to suggest any increased risk.
Fuq il- bażi ta ’ l- esperjenza limitata b’ MabThera f’ pazjenti b’ artrite rewmatika (ara sezzjoni 4. 8), riskju possibbli għall- iżvilupp ta ’ tumuri solidi ma jistax jiġi eskluż f’ dan il- mument, għalkemm l- informazzjoni preżenti donna ma tissuġġerix xi riskju akbar.
Currently, there are limited data on possible drug interactions with MabThera.
Attwalment, teżisti informazzjoni limitata dwar l- interazzjonijiet possibbli ta ’ mediċini oħra ma ’ MabThera.
Co-administration with methotrexate had no effect on the pharmacokinetics of MabThera in rheumatoid arthritis patients.
L- għoti flimkien ma ’ methotrexate ma kellu ebda effett fuq il- farmakokinetiċi ta ’ MabThera f’ pazjenti b’ artrite rewmatika.
Patients with human anti-mouse antibody or human anti-chimeric antibody (HAMA/ HACA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Pazjenti b’ titres ta ’ antikorpi umani ta ’ kontra l- ġrieden jew antikorpi anti- kimeriċi umani (HAMA/ HACA) jista ’ jkollhom reazzjonijiet allerġiċi jew ta ’ sensittività eċċessiva meta trattati flimkien ma ’ antikorpi monoklonali dijanjostiċi jew terapewtiċi oħrajn.
In a small cohort of patients with rheumatoid arthritis, 280 patients received subsequent therapy with other DMARDs of whom 185 received a biologic DMARD following MabThera.
Fi grupp żgħir ta ’ pazjenti b’ artrite rewmatika, 280 pazjent irċevew terapija suċċessiva b’ DMARDs oħra li fosthom 185 irċevew DMARD bijoloġiku wara MabThera.
In these patients the rate of clinically relevant infection while on MabThera only was 6.99 per 100 patient years compared to 5.49 per 100 patients years following treatment with the biologic DMARD.
F’ dawn il- pazjenti ir- rata ta ’ infezzjoni ta ’ rilevanza klinika waqt terapija b’ MabThera kienet ta ’ 6. 99 għal kull 100 sena tal- pazjent meta mqabbel ma 5. 49 għal kull 100 sena tal- pazjent wara kura b’ DMARD bijoloġiku.
Pregnancy IgG immunoglobulins are known to cross the placental barrier.
Tqala Immunoglobulini IgG huma magħrufa li jgħaddu mill- barriera tal- plaċenta.
B cell levels in human neonates following maternal exposure to MabThera have not been studied in clinical trials.
Il- livelli taċ- ċellula B fi trabi umani tat- twelid wara l- esponiment ta ’ l- omm għal MabThera ma ġewx studjati fi provi kliniċi.
There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
M’ hemmx tagħrif adegwat u kkontrollat tajjeb minn studji f’ nisa tqal, iżda ġew irrapportati tnaqqis temporanju taċ- ċelluli B u limfoċitopenija f’ xi trabi li twieldu lill- ommijiiet esposti għal rituximab waqt it- tqala.
For these reasons MabThera should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Għal dawn ir- raġunijiet, jekk il- benefiċċju potenzjali ma jkunx aktar mir- riskju potenzjali, MabThera m’ għandux jingħata lil nisa tqal.
Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during treatment and for 12 months following MabThera therapy.
9 Minħabba t- tul ta ’ żmien li fih jinżamm rituximab f’ pazjenti li jbatu minn telf taċ- ċellula B, nisa li potenzjalment jista ’ jkollhom it- tfal waqt il- kura u għal 12- il xahar wara t- terapija b’ MabThera għandhom jużaw metodi kontraċettivi effettivi.
Developmental toxicity studies performed in cynomolgus monkeys revealed no evidence of embryotoxicity in utero.
Studji dwar l- effett tossiku fuq l- iżvilupp li twettqu fuq xadini cynomolgus ma żvelaw l- ebda evidenza ta ’ effett tossiku fuq l- embriju in utero.
New born offspring of maternal animals exposed to MabThera were noted to have depleted B cell populations during the post natal phase.
Il- frieħ għadhom jitwieldu ta ’ annimali materni esposti għal MabThera kienu nnotati li jkollhom popolazzjonijiet imnaqqsa taċ- ċellula B matul il- fażi ta ’ wara t - twelid.
Lactation Whether rituximab is excreted in human milk is not known.
Treddigħ Mhux magħruf jekk rituximab jitneħħiex fil- ħalib uman.
However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with MabThera and for 12 months following MabThera treatment.
Madanakollu, minħabba li l- IgG matern jinfirex fil- ħalib uman, u rituximab instab fil- ħalib ta ’ xadini li jreddgħu, in- nisa m’ għandhomx ireddgħu waqt li jkunu qed jiġu kkurati b’ MabThera u għal 12- il xahar wara l- kura b’ MabThera.
9 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
No studies on the effects of MabThera on the ability to drive and use machines have been performed, although the pharmacological activity and adverse events reported to date do not indicate that such an effect is likely.
Ma sarux studji dwar l- effetti ta ’ MabThera fuq il- ħila biex issuq u tħaddem magni, għalkemm l - attività farmakoloġika u l- episodji avversi rrapportati sal- lum ma jindikawx li dan l- effett huwa probabbli.
Experience from non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia.
Esperjenza minn limfoma mhux ta 'Hodgkin u lewkimja limfoċitika kronika.
The overall safety profile of MabThera in non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia is based on data from patients from clinical trials and from post-marketing surveillance.
Il- profil ta ’ sigurtà globali ta ’ MabThera f’ limfoma mhux ta ’ Hodgkin u lewkimja limfoċitika kronika huwa bbażat fuq tagħrif minn pazjenti minn provi kliniċi u minn sorveljanza ta 'wara t- tqegħid fis- suq.
These patients were treated either with MabThera monotherapy (as induction treatment or maintenance treatment following induction treatment) or in combination with chemotherapy.
Dawn il- pazjenti kienu kkurati b’ MabThera bħala monoterapija (bħala kura ta ’ induzzjoni jew kura ta ’ manteniment wara kura ta ’ induzzjoni) jew flimkien ma ’ kimoterapija.
The most frequently observed adverse drug reactions (ADRs) in patients receiving MabThera were infusion-related reactions which occurred in the majority of patients during the first infusion.
L- aktar reazzjonijiet avversi tal- mediċina (ADRs) osservati b’ mod frekwenti f’ pazjenti li kienu qed jirċievu MabThera kienu reazzjonijiet relatati ma ’ l- infużjoni li waqt l- ewwel infużjoni seħħew fil - maġġoranza tal- pazjenti.
The incidence of infusion-related symptoms decreases substantially with subsequent infusions and is less than 1% after eight doses of MabThera.
L- inċidenza ta ’ sintomi relatati ma ’ l- infużjoni naqset b’ mod sostanzjali waqt l- infużjonijiet ta ’ wara u hija inqas minn 1% wara tmin dożi ta ’ MabThera.
Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trial in patients with CLL
Avvenimenti infettivi (fil- biċċa l- kbira kkawżati minn batterja jew virusis) seħħew f’ madwar 30- 55% tal- pazjenti waqt provi kliniċi f’ pazjenti b’ NHL u f’ 30- 50% tal- pazjenti waqt prova klinika f’ pazjenti b’ CLL.
The most frequent reported or observed serious adverse drug reactions were: • Infusion-related reactions (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4. • Infections, see section 4.4. • Cardiovascular events, see section 4.4.
L- aktar reazzjonijiet avversi serji tal- mediċina irrapportati jew osservati b’ mod frekwenti kienu: • Reazzjonijiet relatati ma ’ l- infużjoni (inkluż sindrome tar- reħa ta ’ ċitokina, sindrome tal- lisi tat - tumur), ara sezzjoni 4. 4. • Infezzjonijiet, ara sezzjoni 4. 4. • Avvenimenti kardjovaskulari, ara sezzjoni 4. 4.
Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
ADRs serji oħra irrapportati jinkludu riattivazzjoni ta ’ epatite B u PML (ara sezzjoni 4. 4.)
The frequencies of ADRs reported with MabThera alone or in combination with chemotherapy are summarised in the tables below.
Il- frekwenzi ta ’ ADRs irrapportati b’ MabThera waħdu jew flimkien ma ’ kimoterapija huma mqassra fit- tabelli taħt.
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100) and rare (≥ 1/ 10,000 to < 1/ 1000).
Il- frekwenzi huma definiti bħala komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 sa < 1/ 10) u mhux komuni (≥ 1/ 1, 000 sa < 1/ 100) u rari (≥ 1/ 10, 000 sa < 1/ 1000).
The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “ unknown”.
L- ADRs identifikati biss waqt is- sorveljanza ta ’ wara t- tqegħid fis- suq, u li għalihom il- frekwenza ma tistax tiġi stmata, huma mniżżla taħt “ mhux magħruf ”.
Table 1
10 Tabella 1.
ADRs reported in clinical trials or during postmarketing surveillance in patients with NHL and CLL disease treated with MabThera monotherapy/ maintenance or in combination with chemotherapy
ADRs irrapportati fil- provi kliniċi jew waqt sorveljanza ta ’ wara t- tqegħid fis - suq f’ pazjenti bil- mard NHL u CLL ikkurati b’ MabThera bħala monoterapija/ manteniment jew flimkien ma ’ kimoterapija