FrancophonIA/ELRC3.0 huggingface dataset:
English: In CA209017 and CA209063, the incidence of liver function test abnormalities was 1.2% (3/248).
Maltese: F'CA209017 u CA209063, l-inċidenza ta' abnormalitajiet fit-testijiet tal-funzjoni tal-fwied kienet ta' 1.2% (3/248).
English: In CA209017 and CA209063, the incidence of thyroid disorders, including hypothyroidism or thyroiditis, was 4.4% (11/248).
Maltese: F'CA209017 u CA209063, l-inċidenza ta' disturbi tat-tirojde, fosthom ipotirojdiżmu jew tirojdite, kienet ta' 4.4% (11/248).
English: Posology
Maltese: RESPONSABBLI
English: The estimated 1-year survival rate was 41%.
Maltese: Ir-rata ta' sopravivenza ta' sena stmata kienet 41%.
English: Each mL of this medicinal product contains 0.1 mmol (or 2.5 mg) sodium.
Maltese: Kull mL ta' dan il-prodott mediċinali fih 0.1 mmol (jew 2.5 mg) sodju.
English: Nivolumab BMS concentrate may be diluted with either: sodium chloride 9 mg/mL (0.9%) solution for injection; or 50 mg/mL (5%) glucose solution for injection.
Maltese: Il-konċentrat ta' Nivolumab BMS jista' jiġi dilwit b': sodium chloride 9 mg/mL (0.9%) soluzzjoni għal injezzjoni; jew 50 mg/mL (5%) soluzzjoni tal-glukożju għal injezzjoni.
English: Severe hepatitis has been observed with nivolumab treatment.
Maltese: Ġiet osservata epatite severa b'kura b'nivolumab.
English: Based on the severity of the adverse reaction, nivolumab should be withheld and corticosteroids administered.
Maltese: Abbażi tas-severità tarreazzjoni avversa, nivolumab għandu jitwaqqaf u jingħataw kortikosterojdi.
English: The volume of Nivolumab BMS concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the Nivolumab BMS concentrate strength is 10 mg/mL).
Maltese: Il-volum tal-konċentrat ta' Nivolumab BMS biex titħejja d-doża (mL) = id-doża totali f'mg, diviża b'10 (is-saħħa tal-konċentrat ta' Nivolumab BMS hija ta' 10 mg/mL).
English: Prior to launch of Nivolumab BMS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Nivolumab BMS f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (Marketing Authorisation Holder, MAH) għandu jiftiehem fuq il-kontenut u l-format tal-programm edukattiv, inklużi l-mezzi tal-komunikazzjoni, il-modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Severe diarrhoea or colitis has been observed with nivolumab treatment (see section 4.8).
Maltese: Dijarea jew kolite severa ġew osservati b'kura b'nivolumab (ara sezzjoni 4.8).
English: Signs and symptoms may include abnormal kidney function tests, or decreased volume of urine.
Maltese: Sinjali u sintomi jistgħu jinkludu testijiet tal-funzjoni tal-fwied mhux normali jew tnaqqis fil-volum ta' awrina.
English: The prescriber must discuss the risks of Nivolumab BMS therapy with the patient.
Maltese: Dak li jordna l-mediċina għandu jiddiskuti r-riskji ta' kura b' Nivolumab BMS mal-pazjent.
English: Resolution occurred in 5 patients (71%), including the Grade 3 case, with a median time to resolution of 5.9 weeks (range: 0.7- 37.6+); + denotes a censored observation.
Maltese: Riżoluzzjoni seħħet f'5 pazjenti (71%), inkluż il-każ ta' Grad 3, b'żmien medjan għal riżoluzzjoni ta' 5.9 ġimgħat (medda: 0.7-37.6+); + jindika osservazzjoni ċċensurata.
English: Grade 2 and Grade 3 cases were reported in 1.2% (3/248) and 0.4% (1/248) of patients, respectively.
Maltese: Każijiet ta' Grad 2 u Grad 3 ġew irrapportati f'1.2% (3/248) u 0.4% (1/248) tal-pazjenti, rispettivament.
English: For instructions on the handling of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar il-ġestjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Grade 2 and Grade 3 cases were reported in 2% (5/248) and 1.6% (4/248) of patients, respectively.
Maltese: Każijiet ta' Grad 2 u Grad 3 ġew irrapportati f'2% (5/248) u 1.6% (4/248) tal-pazjenti, rispettivament.
English: Uncommon (may affect up to 1 in 100 people) Bronchitis, infections of the upper respiratory tract A disease causing the inflammation or enlargement of a lymph node (Kikuchi lymphadenitis) Allergic reaction, reactions related to the administration of the medicine Adrenal glands not working properly, inflammation of the thyroid gland A condition in which the muscles become weak and tire easily (myasthenic syndrome), damage to the nerves in different parts of the body that can cause decreased feeling or affect movement
Maltese: Bronkite, infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju Marda li tikkawża l-infjammazzjoni jew it-twessigħ ta' glandoli limfatiċi (limfadenite Kikuchi) Reazzjoni allerġika, reazzjonijiet relatati mal-għoti tal-mediċina Il-glandoli adrenali mhumiex qegħdin jaħdmu sew, infjammazzjoni tal-glandola tat-tirojde Kundizzjoni fejn il-muskoli jsiru dgħajfin u jgħajjew faċilment (sindromu mijasteniku), ħsara fin-nervituri f'partijiet differenti tal-ġisem li tista' tikkawża nuqqas fis-sens tal-mess jew
English: In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.
Maltese: F'mudelli tal-ġrieden sinġeneiċi, l-imblukkar tal-attività ta' PD-1 irriżulta fi tkabbir imnaqqas tat-tumur.
English: If you become pregnant while using Nivolumab BMS tell your doctor.
Maltese: Jista' jkun hemm il-bżonn ta' aktar minn kunjett wieħed ta' Nivolumab BMS biex tinkiseb id-doża meħtieġa.
English: Immune-related colitis
Maltese: Pulmonite relatata massistema immunitarja
English: Single-arm phase 2 study (CA209063)
Maltese: Studju ta' fażi 2 b'fergħa waħda (CA209063)
English: For Grade 2 or 3 serum creatinine elevation, nivolumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Maltese: Għal elevazzjoni tal-kreatinina ta' Grad 2 jew 3 fis-serum, nivolumab għandu jiġi interrott u għandhom jinbdew il-kortikosterojdi b'doża ta' 0.5 sa 1 mg/kg/jum ta' ekwivalenti għall-methylprednisolone.
English: For symptomatic diabetes, nivolumab should be withheld, and insulin replacement should be initiated as needed.
Maltese: Għal dijabete sintomatika, nivolumab għandu jitwaqqaf, u għandha tinbeda terapija ta' sostituzzjoni tal-insulina skont il-ħtieġa.
English: withhold the next dose of Nivolumab BMS,
Maltese: jinterrompi d-doża li jmissek ta' Nivolumab BMS,
English: The total dose of Nivolumab BMS required can be infused directly as a 10 mg/mL solution or can be diluted to as low as 1 mg/mL with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection.
Maltese: Id-doża totali meħtieġa ta' Nivolumab BMS tista' tiġi infuża direttament bħala soluzzjoni ta' 10 mg/mL jew tista' tiġi dilwita bħala 1 mg/mL soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride jew soluzzjoni għall-injezzjoni ta' 50 mg/mL (5%) glukożju.
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Maltese: Linji gwida dettaljati għall-ġestjoni ta' reazzjonijiet avversi relatati mas-sistema immunitarja huma deskritti f'sezzjoni 4.4.
English: Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion.
Maltese: It-tħaddim ta' PD-1 ma' ligandi PD-L1 u PD-L2 li huma espressi f'ċelluli li jkun fihom antiġen u jistgħu jiġu espressi minn tumuri jew ċelloli oħrajn fil-mikroambjent tat-tumuri, jirriżulta f'inibizzjoni tal-proliferazzjoni taċ-ċelloli-T u s-sekrezzjoni taċ-ċitokina.
English: Corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents should also be considered if acute inflammation of the pituitary gland is suspected.
Maltese: Kortikosterojdi f'doża ta' 1 sa 2 mg/kg/jum ekwivalenti ta' methylprednisolone għandhom jiġu kkunsidrati wkoll jekk tiġi ssuspettata infjammazzjoni akuta talglandola pitwitarja.
English: Concentrate for solution for infusion.
Maltese: Konċentrat għal soluzzjoni għal infużjoni.
English: No dose adjustment is required for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża għal pazjenti anzjani (≥ 65 sena) (ara sezzjonijiet 5.1 u 5.2).
English: Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, pain in jaw, spinal pain.
Maltese: Uġigħ muskoluskeletrali huwa terminu kompost li jinkludi uġigħ fid -dahar, uġigħ fl-għadam, uġigħ fissider muskuloskeletriku, skumdità muskoloskeletrali, mijalġija, uġigħ fl-għonq, uġigħ fl-estremitajiet, uġigħ fil-ġogi, uġigħ spinali.
English: No clinically important differences in the CL of nivolumab were found between patients with mild or moderate renal impairment and patients with normal renal function.
Maltese: Ma nstabet ebda differenza klinikament importanti fis-CL ta' nivolumab bejn pazjenti b'indeboliment tal-kliewi ħafif jew moderat u pazjenti b'funzjoni normali tal-kliewi.
English: It is very important for you to keep all your appointments to receive Nivolumab BMS.
Maltese: Huwa ferm importanti li tmur għall-appuntamenti kollha tiegħek biex tirċievi Nivolumab BMS.
English: Grade 2 and Grade 3 cases were reported in 1.6% (4/248) and 0.8% (2/248) of patients, respectively.
Maltese: Każijiet ta' Grad 2 u Grad 3 ġew irrapportati f'1.6% (4/248) u 0.8% (2/248) tal-pazjenti, rispettivament
English: If not used immediately, chemical and physical in-use stability of Nivolumab BMS has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 4 hours at 20°C-25°C and room light (this 4-hour period of the total 24 hours should be inclusive of the product administration period).
Maltese: Jekk ma tintużax minnufih, l-istabbiltà kimika u fiżika waqt l-użu ta' Nivolumab BMS intweriet għal 24 siegħa f'temperatura ta' 2 sa 8°C protett mid-dawl u sa massimu ta' 4 sigħat f'temperatura ta' 20°C-25°C u dawl tal-kamra (dan il-perijodu ta' 4 sigħat mit-total ta' 24 siegħa għandu jkun jinkludi
English: Uncommon bronchitis, upper respiratory tract infection Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon histocytic necrotising lymphadenitis (Kikuchi lymphadenitis) Immune system disorders
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni bronkite, infezzjoni fil-parti ta' fuq tal-apparat respiratorju Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Mhux komuni limfadenite nekrotika istjosistika (limfadenite Kikuchi) reazzjoni anafilattika, sensittività eċċessiva, reazzjoni marbuta mal -infużjoni newropatija periferika, uġigħ ta ' ras, sturdament
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 372 6827 400
Maltese: BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. Tel.: + 48 22 5796666
English: Resolution occurred in 2 patients (67%) with a median time to resolution of 4.1 weeks (range: 2.9-22.3+); + denotes a censored observation.
Maltese: Riżoluzzjoni seħħet f'2 pazjenti (67%) b'żmien medjan għal riżoluzzjoni ta' 4.1 ġimgħat (medda: 2.9-22.3+); + jindika osservazzjoni
English: For Grade 4 serum creatinine elevation, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Għal elevazzjoni tal-kreatinina fis-serum ta' Grad 4, nivolumab għandu jitwaqqaf b'mod permanenti, u għandhom jimbdew il-kortikosterojdi b'doża ta' 1 sa 2 mg/kg/jum ta' ekwivalenti
English: Post-authorisation efficacy study (PAES): The MAH should submit an updated OS data for Study CA209017: a Phase 3, randomized study of nivolumab vs docetaxel in subjects with advanced or metastatic squamous NSCLC who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen.
Maltese: Il-MAH għandu jissottometti dejta OS aġġornata għallIstudju CA209017: studju randomizzat ta' Fażi 3 ta' nivolumab vs docetaxel f'individwi b'NSCLC skwamuż avvanzat jew metastatiku li esperjenzaw progressjoni tal-marda matul jew wara reġimen ta' kemoterapija bbażata fuq doublet tal-platinum preċedenti.
English: To further investigate at post-approval the possible change in PD-L1 status of the tumour during treatment and/or tumour progression in Studies CA209-009, CA209-038 and CA209-064.
Maltese: Sabiex tiġi investigata aktar, f'fażi wara l-approvazzjoni, il-bidla possibbli fl-istatus tal-PD-L1 tat-tumur matul il-kura u/jew ilprogressjoni tat-tumur l-Istudji CA209-009, CA209-038 u
English: See leaflet for further information.
Maltese: Ara l-fuljett ta' tagħrif għal iktar informazzjoni.
English: For Grade 3 or 4 pneumonitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Maltese: Għal pulmonite ta' Grad 3 jew 4, nivolumab għandu jitwaqqaf b'mod permanenti u l-kortikosterojdi għandhom jinbdew b'doża ekwivalenti għal 2 sa 4 mg/kg/jum ta'methylprednisolone.
English: If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 4 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Maltese: Jekk ma tintużax minnufih, is-soluzzjoni tista' tinħażen f'kundizzjonijiet tat-tkessiħ (2°C-8°C) u tiġi protetta mid-dawl sa 24 siegħa [massimu ta' 4 sigħat mill-24 siegħa totali jistgħu jkunu f'temperatura ambjentali (20°C-25°C) u dawl tal-kamra].
English: One patient required permanent discontinuation of nivolumab due to Grade 2 increases in transaminases.
Maltese: Pazjent wieħed kellu bżonn ta' twaqqif permanenti ta' nivolumab minħabba żidiet ta' Grad 2 f'transaminases.
English: Patients should be monitored for signs and symptoms of nephritis and renal dysfunction.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' nefrite u disfunzjoni renali.
English: However, the role of this biomarker (PD-L1 expression) has not been fully elucidated.
Maltese: Madankollu, ir-rwol ta' dan il-bijomarkatur (espressjoni PD-L1) ma ġietx spjegata
English: Diarrhoea (watery, loose or soft stools), mouth ulcers and cold sores (stomatitis), vomiting, stomach pain, constipation, dry mouth
Maltese: Dijarea (ippurgar mimli ilma, maħlul jew artab), ulċeri tal-ħalq u infafet tad-deni (stomatite), rimettar, uġigħ fl-istonku, stitikezza, ħalq xott
English: Nivolumab is associated with immune-related adverse reactions.
Maltese: Nivolumab huwa assoċjat l-aktar ma' reazzjonijiet avversi relatati mal-immunità.
English: Eight patients, including the 4 patients with a Grade 3 case, required permanent discontinuation of nivolumab due to pneumonitis.
Maltese: Tmien pazjenti, inkluż 4 pazjenti b'każ ta' Grad 3 kellhom bżonn ta' twaqqif permanenti ta' nivolumab minħabba pnewmonite.
English: To further investigate the value biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other methods / assays, and associated cut-offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1, PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, etc.) as predictive of nivolumab efficacy.
Maltese: Sabiex jiġu investigati aktar il-bijomarkaturi tal-valuri għajr l-istatus ta' espressjoni ta' PD-L1 fil-livell tal-membrana taċ-ċelloli tat-tumuri minn IHC (eż., metodi / assaġġi oħrajn, u cut-offs assoċjati, li jistgħu jirriżultaw aktar sensittivi u speċifiċi fit-tbassir tar-rispons għall-kura abbażi ta' PD-L1, PD-L2, limfoċiti li jinfiltraw it-tumur b'kejl taddensità CD8+T, firma RNA, eċċ.) bħala ta' tbassir tal-effikaċja ta' nivolumab.
English: Nivolumab BMS should also be permanently discontinued for Grade 2 or 3 immune-related adverse reactions that persist despite treatment modifications (see section 4.4) or for inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day.
Maltese: Nivolumab BMS għandu jitwaqqaf għal kollox wkoll għal reazzjonijiet avversi relatati mas-sistema immunitarja ta' Grad 2 jew 3 li jippersistu minkejja modifiki fil-kura (ara sezzjoni 4.4) jew jekk ma tkunx tista' titnaqqas id-doża ta' kortikosterojdi għal 10 mg prednisone jew ekwivalenti kuljum.
English: Disposal
Maltese: Interrompi
English: Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Maltese: Uża sett tal-infużjoni u filtru fil pajp, sterilizzat, mhux tal ħġieġ li ftit li xejn jillega l proteini miegħu (daqs tal pori ta' 0.2 μm sa 1.2 μm).
English: BRISTOL-MYERS SQUIBB, S.A.
Maltese: Bristol-Myers Squibb B.V.
English: These additional biomarker analyses are occurring in the context of Study CA209-038 and Study CA209-066.
Maltese: Dawn l-analiżi addizzjonali b'bijomarkaturi qegħdin iseħħu fil-kuntest tal-Istudju CA209-038 u Studju CA209-066.
English: No clinically important differences in the CL of nivolumab were found between patients with mild hepatic impairment and normal hepatic function.
Maltese: Ma nstabet ebda differenza klinikament importanti fis-CL ta' nivolumab bejn pazjenti b'indeboliment ħafif tal-fwied u funzjoni normali tal-fwied.
English: Very common increased AST,bincreased ALT,b increased alkaline phosphatase,b increased creatinine,b decreased lymphocytes,b decreased platelet count,b decreased haemoglobin,b hypercalcaemia,b hypocalcaemia,b hyperkalaemia,b hypokalaemia,b hypomagnesaemia,b hyponatraemiab
Maltese: Għalkemm l-istat tal-ECOG, ir-rata ta' filtrazzjoni glomerulari (glomerular filtration rate, GFR) tal-linja bażi, albumina, piż tal-ġisem, u indeboliment tal-fwied ħafif kellu effett fuq nivolumab CL, l-effett ma kienx klinikament
English: Three patients, including 2 patients with a Grade 3 case, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 0.6 mg/kg (range: 0.4-1.3) for a median duration of 2.0 weeks (range: 1.4-14.1).
Maltese: Tliet pazjenti, inklużi żewġ pazjenti b'każ ta' Grad 3, irċevew kortikosterojdi ta' doża għolja (tal-inqas 40 mg ta' ekwivalenti għal prednisone) f'doża inizjali medjana ta' 0.6 mg/kg (medda: 0.4-1.3) għal tul ta' żmien medjan ta' 2.0 ġimgħat (medda: 1.4-14.1).
English: There was no evidence of altered pharmacokinetic or toxicity profile associated with anti-product-antibody development.
Maltese: Ma kien hemm l-ebda evidenza ta' farmakokinetika jew profil ta' tossiċità mibdula assoċjata mal-iżvilupp tal-antikorpi kontra l-prodott.
English: No overall differences in safety or efficacy were reported between elderly ( ≥ 65 years) and younger patients (< 65 years).
Maltese: L-ebda differenzi ġenerali fis-sigurtà u l-effikaċja ma kienu osservati bejn pazjenti anzjani (≥ 65 sena) u pazjenti iżgħar (< 65 sena).
English: Inflammation of the intestines (colitis), ulcer of the small intestines Inflammation of muscles causing pain or stiffness
Maltese: Infjammazzjoni tal-imsaren (kolite), ulċera tal-intestini ż-żgħar
English: The preliminary results show that systemic immunosuppression after starting nivolumab treatment does not appear to preclude the response on nivolumab.
Maltese: Ir-riżultati preliminari juru li immunosuppressjoni sistemika wara li tinbeda l-kura b'nivolumab ma jidhirx li tipprekludi r-rispons fuq nivolumab.
English: For Grade 4 diarrhoea or colitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Għal dijarea jew kolite tal-Grad 4, nivolumab għandu jitwaqqaf b'mod permanenti, u għandhom jinbdew kortikosterojdi f'doża ta' 1 sa 2 mg/kg/kuljum f'ekwivalenti ta' methylprednisolone.
English: 100 mg/10 mL
Maltese: Kunjett tal-10 mL fih 100 mg nivolumab.
English: For Grade 3 diarrhoea or colitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Għal dijarea jew kolite tal-Grad 3, nivolumab għandu jitwaqqaf u għandhom jinbdew ilkortikosterojdi f'doża ta' 1 sa 2 mg/kg/kuljum f'ekwivalenti ta' methylprednisolone.
English: Other forms of interaction
Maltese: Forom oħra ta' interazzjoni
English: Nivolumab BMS is a medicine used to treat advanced non-small cell lung cancer (a type of lung cancer) in adults.
Maltese: Nivolumab BMS hu mediċina li tintuża għall-kura ta' kanċer avvanzat tal-pulmun ta' ċelluli mhux żgħar (tip ta' kanċer tal-pulmun) fl-adulti.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 10 mg of nivolumab.
Maltese: Kull mL konċentrat fih 10 mg nivolumab.
English: Although hyperparathyroidism was not reported in CA209017, immune-related hyperparathyroidism might be considered especially if associated with hypophosphataemia (reported in 6 hypercalcemic patients in this study).
Maltese: Għalkemm iperparatirojdiżmu ma ġiex irrapportat f'CA209017, iperparatirojdiżmu relatat malimmunità jista' jitqies b'mod speċjali jekk ikun assoċjat ma' ipofosfatemja (irrapportata f'6 pazjenti
English: Glass bottles
Maltese: Tħawdux.
English: These analyses will be conducted in Studies CA 209037 and CA209066 in patients with advanced melanoma.
Maltese: Dawn l-analiżi sejrin isiru fl-Istudji CA 209037 u CA209066 f'pazjenti b'melanoma
English: It is to be administered as an intravenous infusion over a period of 60 minutes.
Maltese: Għandu jingħata bħala infużjoni tul perijodu ta' 60 minuta.
English: Withhold Nivolumab BMS until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Maltese: Waqqaf Nivolumab BMS sakemm jitilqu s-sintomi, jitjiebu l-abnormalitajiet radjografiċi u titlesta l-ġestjoni bil-kortikosterojdi
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab treatment (see section 4.8).
Maltese: Bil-kura b'nivolumab ġiet osservata pulmonite severa jew marda interstizjali severa tal-pulmun, li jinkludu każi fatali (ara sezzjoni 4.8).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'nivolumab f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-kura ta' tumuri solidi malinni (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Maltese: Il-konċentrat ta' Nivolumab BMS jista' jiġi dilwit jew soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride; jew soluzzjoni għall-injezzjoni ta' 50 mg/mL (5%) glukożju.
English: However, based on its mechanism of action, foetal exposure to nivolumab may increase the risk of developing immune-related disorders or altering the normal immune response and immune-related disorders have been reported in PD-1 knockout mice.
Maltese: Madankollu, abbażi tal-mekkaniżmu ta' azzjoni tiegħu, l-espożizzjoni fetali għal nivolumab tista' żżid ir-riskju li jiġu żviluppati disturbi relatati mas-sistema immuni jew li jinbidlu r-risponsi immunitarji normali u disturbi relatati mas-sistema immuni ġew irrapportati fi ġrieden żgħar b'PD-1.
English: 6.1 List of excipients
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Severe rash has been observed with nivolumab treatment that may be immune-related (see section 4.8).
Maltese: Raxx sever ġie osservat bil-kura b'nivolumab li jista' jkun relatat mal-immunità (ara sezzjoni 4.8).
English: Common increased total bilirubin,b decreased absolute neutrophil count,b hypermagnesaemia,b, hypernatraemiab
Maltese: Minħabba li bosta prodotti mediċinali, inkluż antikorpi, jistgħu jiġu eliminati fil-ħalib tal-mara, riskju għat-trabi tat-twelid/trabi mhux eskluż.