FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 " Nivolumab BMS contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: Is-sustanzi(i) l-oħra hi (huma) sodium citrate dihydrate, sodium chloride (ara sezzjoni 2 “Nivolumab BMS fih sodium”), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet.
English: Nivolumab 3 mg/kg (events : 86/135), median and 95% CI : 9.23 (7.33, 13.27)
Maltese: Nivolumab 3 mg/kg (avvenimenti: 86/135), medjan u 95% CI: 9.23 (7.33, 13.27) Docetaxel (avvenimenti: 113/137), medjan u 95% CI: 6.01 (5.13, 7.33)
English: For storage conditions after preparation of the infusion, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-preparazzjoni tal-infużjoni, ara sezzjoni 6.3.
English: Efficacy results (CA209017)
Maltese: (CA209017 u CA209063)
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 340 mOsm/kg.
Maltese: Is-soluzzjoni għandha pH ta' madwar 6.0 u osmolalità ta' madwar 340 mOsm/kg.
English: Each vial contains either 40 mg (in 4 mL) or 100 mg (in 10 mL) of nivolumab.
Maltese: Kull kunjett fih 40 mg (f'4 mL) jew 100 mg (f'10 mL) nivolumab.
English: Lonza Biologics, Inc.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Lonza Biologics, Inc.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur talawtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal
English: See “Description of selected adverse reactions; laboratory abnormalities” below.
Maltese: Ara “Deskrizzjoni ta' reazzjonijiet avversi magħżula; anormalitajiet tal-laboratorju” iktar ‘il quddiem.
English: The median age was 63 years (range: 39-85) with 44% ≥65 years of age and 11% ≥75 years of age.
Maltese: L-età medjana kienet ta' 63 sena (medda: 39-85) b'44% li għandhom ≥65 sena u 11% li għandhom ≥75 sena.
English: In addition, symptom improvement and overall health status were assessed using the Lung Cancer Symptom Score (LCSS) average symptom burden index and the EQ-5D Visual Analogue Scale (EQ-VAS), respectively.
Maltese: Analoga Viżwali EQ-5D (EQ-VAS - EQ-5D Visual Analogue Scale), rispettivament.
English: The majority of patients were white (93%) and male (76%).
Maltese: Ilmaġġoranza tal-pazjenti kienu bojod (93%) u rġiel (76%).
English: The final infusion concentration should range between 1 and 10 mg/mL.
Maltese: Il-konċentrazzjoni tal-infużjoni finali għandha tvarja bejn 1 u 10 mg/mL.
English: Median time to onset was 25.1 weeks (range: 4.1-31.1).
Maltese: 1 ġimgħat (medda: 4.1-31.1).
English: Median time to onset was 5.6 weeks (range: 0.1-91.0).
Maltese: Iż-żmien medjan għall-feġġa kien ta' 5.6 ġimgħat (medda: 0.1-91.0).
English: The following immune-related adverse reactions were reported in less than 1% of patients treated with nivolumab in clinical trials across doses and tumour types: pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, hypopituitarism, and myasthenic syndrome.
Maltese: Ir-reazzjonijiet avversi li ġejjin relatati mal-immunità ġew irrappurtati f'inqas minn 1% tal-pazjenti kkurati b'nivolumab fi provi kliniċi dwar id-dożi u tipi ta' tumuri: pankreatite, uveite, demyelination, newropatija awtoimmuni (li tinkludi paresi tan-nerv tal-wiċċ u abducens tal-għajn), is-sindromu ta' Guillain-Barré, ipopitwitariżmu, u sindrome mijasteniku.
English: Key secondary efficacy outcome measures were investigator-assessed objective response rate (ORR) and progression-free survival (PFS).
Maltese: Il-miżuri sekondarji ewlenin tal-eżitu tal-effikaċja kienu r-rata ta' rispons oġġettiv ivvalutut mill-investigatur (ORR - objective response rate) u sopravivenza mingħajr progress (PFS - progression-free survival).
English: The rate of disease-related symptom improvement, as measured by LCSS, was similar between the nivolumab group (18.5%) and the docetaxel group (21.2%).
Maltese: Ir-rata ta' titjib fis-sintomi relatati mal-marda, kif imkejla mil-LCSS, kienet simili bejn il-grupp ta' nivolumab (18.5%) u l-grupp ta' docetaxel (21.2%).
English: Grade 3 or 4 elevation in AST, ALT, or
Maltese: Ebda każ ta' Grad 3-5
English: In the pooled dataset of two studies in squamous NSCLC (CA209017 and CA209063), the most frequent adverse reactions (≥ 10% of patients) were fatigue (33%), decreased appetite (15%), and nausea (12%).
Maltese: Fis-sett ta' dejta kondiviż ta' żewġ studji f'NSCLC skwamużi (CA209017 u CA209063), l-iktar reazzjonijiet avversi spissi (≥ 10% tal-pazjenti) kienu għeja (33%), tnaqqis fl-aptit (15%), u dardir (12%).
English: There was no worsening to Grade 3 or 4 in increased ALT, increased alkaline phosphatase, and increased creatinine.
Maltese: Ma kien hemm ebda aggravar għal Grad 3 jew 4 f'żieda fl-ALT, żieda fl-alkaline phosphatase, u żieda fil-creatinine.
English: Nivolumab BMS infusion is compatible with: PVC containers
Maltese: Settijiet tal-infużjoni tal-PVC
English: Nivolumab has not been studied in patients with moderate (total bilirubin > 1.5 × to 3 × ULN and any AST) or severe hepatic impairment (total bilirubin > 3 × ULN and any AST) (see section 4.2).
Maltese: Nivolumab ma ġiex studjat f'pazjenti b'indeboliment tal-fwied moderat (bilirubina totali > 1.5 × sa 3 × ULN u kwalunkwe AST) jew sever (bilirubina totali > 3 × ULN u kwalunkwe AST) (ara sezzjoni 4.2).
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: The effect of renal impairment on the CL of nivolumab was evaluated in patients with mild (GFR < 90 and ≥ 60 mL/min/1.73 m2; n = 379), moderate (GFR < 60 and ≥ 30 mL/min/1.73 m2; n = 179), or severe (GFR < 30 and ≥ 15 mL/min/1.73 m2; n = 2) renal impairment compared to patients with normal renal function (GFR ≥ 90 mL/min/1.73 m2; n = 342) in population PK analyses.
Maltese: L-effett tal-indeboliment tal-kliewi fuq is-CL ta' nivolumab ġie evalwat f'pazjenti b'indeboliment tal-kliewi ħafif (GFR < 90 u ≥ 60 mL/min/1.73 m 2; n = 379), moderat 2; n = 179), jew sever (GFR < 30 u ≥ 15 mL/min/1.73 m 2; n = 2)
English: Administer the Nivolumab BMS infusion intravenously over a period of 60 minutes.
Maltese: Agħti l-infużjoni ta' Nivolumab BMS ġol-vina fuq 60 minuta.
English: Vistor hf.
Maltese: Tħawwadx ilkunjett.
English: Study CA209063 was a single-arm, open-label study conducted in 117 patients with locally advanced or metastatic squamous-NSCLC after two or more lines of therapy; otherwise similar inclusion criteria as study CA209017 were applied.
Maltese: Studju CA209063 kien studju b'fergħa waħda, open-label li sar fuq 117-il pazjent b'NSCLC skwamuż lokalment avvanzat jew metastatiku wara żewġ linji ta' terapija jew aktar; inkella ġew applikati kriterji ta' inklużjoni simili għal dawk tal-istudju CA209017.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: Data for the following immune-related adverse reactions are based on patients who received nivolumab 3 mg/kg in two NSCLC studies (CA209017 and CA209063, see section 5.1).
Maltese: Dejta għar-reazzjonijiet avversi relatati mas-sistema immunitarja li ġejjin hija bbażata fuq pazjenti li rċevew 3 mg/kg f'żewġ studji NSCLC (CA209017 u CA209063, ara sezzjoni 5.1).
English: The following side effects have been reported in clinical trials with nivolumab:
Maltese: Fil-provi kliniċi b'nivolumab ġew irrapportati l-effetti sekondarji li ġejjin:
English: Immune-related endocrinopathies
Maltese: Endokrinopatiji relatati mas-sistema immuni
English: To further investigate the associative analyses between PDL-1 and PDL-2 expression conducted in Study CA209-066.
Maltese: Sabiex tiġi investigata aktar l-analiżi assoċjattiva bejn l-espressjoni PDL-1 u PDL-2 imwettqa fl-Istudju CA209-066.
English: A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, tumour type, tumour size, and hepatic impairment.
Maltese: Analiżi PK tal-popolazzjoni ma ssuġġeriet ebda differenza fis-CL ta' nivolumab fuq il-bażi ta' età, sess, razza, tip ta' tumur, daqs tat-tumur, u indeboliment tal-fwied.
English: o Immune-related nephritis or renal dysfunction
Maltese: Nefrite u disfunzjoni renali relatati mas-sistema immunitarja
English: Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80
Maltese: Pentetic acid (diethylenetriaminepentaacetic acid) Sodium hydroxide (għall-aġġusament tal-pH) Hydrochloric acid (għall-aġġusament tal-pH)
English: Body weight normalised dosing produced approximately uniform steady-state trough concentration over a wide range of body weights (34-162 kg).
Maltese: Dożaġġ normalizzat għall-piż tal-ġisem ipproduċa konċentrazzjoni minima fi stat fissi tul medda wiesgħa ta' piżijiet tal-ġisem (34-162 kg).
English: Grade 2 cases were reported in 3.6% (9/248) of patients.
Maltese: Każijiet ta' Grad 2 ġew irrapportati f'3.6% (9/248) tal-pazjenti.
English: Recommended treatment modifications for Nivolumab BMS
Maltese: Modifiki rrakkomandati tal-kura għal Nivolumab BMS
English: Severe nephritis or renal dysfunction has been observed with nivolumab treatment (see section 4.8).
Maltese: Ġiet osservata nefrite severa jew disfunzjoni renali b'kura b'nivolumab (ara sezzjoni 4.8).
English: Nivolumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Maltese: Nivolumab huwa mistenni jiġi degradat f'peptidi żgħar u aċidi aminiċi permezz ta' passaġġi kataboliċi bl-istess mod bħal IgG endoġena.
English: Two patients (1 with Grade 2 rash and 1 with Grade 3 rash) required permanent discontinuation of nivolumab.
Maltese: Żewġ pazjenti (1 b'raxx ta' Grad 2 u 1 b'raxx ta' Grad 3) kienu jeħtieġu t-twaqqif permanenti ta' nivolumab.
English: Median time to onset of these endocrinopathies was 17.8 weeks (range: 6.1-33.1).
Maltese: Iż-żmien medjan għall-feġġa ta' dawn l-endokrinopatiji kien ta' 17.8 ġimgħat (medda: 6.1-33.1).
English: One vial of 4 mL contains 40 mg of nivolumab.
Maltese: Kull kunjett ta' 4 mL fih 40 mg nivolumab.
English: • Periodic safety update reports
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà (Periodic Safety Update Report, PSUR)
English: Severe infusion reactions have been reported in clinical trials (see section 4.8).
Maltese: Reazzjonijiet severi għall-infużjoni ġew irrapportati fi provi kliniċi (ara sezzjoni 4.8).
English: In CA209017 and CA209063, the incidence of pneumonitis, including interstitial lung disease, was 5.2% (13/248).
Maltese: F'CA209017 u CA209063, l-inċidenza ta' pulmonite, inkluż mard pulmonari intersitzjali, kienet ta' 5.2% (13/248).
English: Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Maltese: Nivolumab huwa prodott fiċ-ċelloli tal-ovarji tal-ħamster Ċiniż b'teknoloġija tad-DNA rikombinanti.
English: Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, symptomatic interstitial lung disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the clinical trials of NSCLC (see sections 4.5 and 5.1).
Maltese: Pazjenti b'punteġġ tal-prestazzjoni fil-linja bażi ta' ≥ 2, b'metastasi attivi fil-moħħ jew mard awtoimmuni, mard interstizjali sintomatiku tal-pulmun, u pazjenti li kienu qegħdin jirċievu immunosuppressanti sistemiċi qabel ma daħlu fl-istudju ġew esklużi mill-provi kliniċi ta' NSCLC (ara sezzjonijiet 4.5 u 5.1).
English: To further investigate at post-approval the relation between PDL-1 and PDL-2 expression in Phase 1 (CA209009, CA209038 and
Maltese: 3. Sabiex tiġi investigata aktar, f'fażi wara l-approvazzjoni, ir-relazzjoni bejn l-espressjoni PDL-1 u PDL-2 fil-Fażi 1 (CA209009, CA209038
English: 30th September 2017
Maltese: 30 ta' Settembru 2017
English: The effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis in the first trimester through delivery, at exposure levels either 8 or 35 times higher than those observed at the clinical dose of 3 mg/kg of nivolumab (based on AUC).
Maltese: L-effetti ta' nivolumab fuq l-iżvilupp qabel u wara t-twelid fix-xadini ġew evalwati wara li ngħataw nivolumab darbtejn fil-ġimgħa malli feġġet l-organoġenesi fl-ewwel trimestru sal-ħlas, b'livelli ta' esponiment ta' 8 jew 35 darba ogħla minn dawk osservati bid-doża klinika ta' 3 mg/kg ta' nivolumab (fuq il-bażi tal-AUC).
English: Excipient with known effect Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
Maltese: Kull mL tal-konċentrat fih 0.1 mmol (jew 2.5 mg) sodju.
English: PVC infusion sets In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Maltese: Filtri fil pajp b'riti tal polyethersulfone b'daqsijiet tal pori ta' 0.2 μm sa 1.2 μm.
English: In CA209017 and CA209063, the incidence of rash was 12.1% (30/248).
Maltese: F'CA209017 u CA209063, l-inċidenza ta' raxx kienet ta' 12.1% (30/248).
English: Nivolumab BMS 10 mg/mL concentrate for solution for infusion nivolumab
Maltese: Nivolumab BMS 10 mg/mL konċentrat sterili
English: Elderly
Maltese: Dawn
English: Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body's natural defences).
Maltese: Nivolumab jeħel ma' proteina fil-mira msejħa riċettur ta' mewta-1 programmata (PD-1) li tista' titfi lattività taċ-ċelloli T (tip ta' ċelloli tad-demm bojod li jifforma parti mis-sistema immunitarja, id-difiża naturali tal-ġisem).
English: A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (N = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks.
Maltese: Total ta' 272 pazjenti ntgħażlu b'mod każwali sabiex jirċievu jew 3 mg/kg nivolumab (N = 135) mogħti ġol-vina għal 60 minuta kull ġimagħtejn jew docetaxel (n = 137) 75 mg/m kull 3 ġimgħat.
English: Median time to onset was 11.6 weeks (range: 2.6-85.1).
Maltese: Iż-żmien medjan biex titfaċċa kien ta' 11.6 ġimgħat (medda: 2.6-85.1).
English: No Grade 3-5 thyroid disorders were reported.
Maltese: Ebda disturb tat-tirojde ta' Grad 3-5 ma ġie rrapportat.
English: In CA209017 and CA209063, the incidence of nephritis or renal dysfunction was 3.2% (8/248).
Maltese: F'CA209017 u CA209063, l-inċidenza ta' nefrite jew ta' disfunzjoni renali kienet ta' 3.2% (8/248).
English: Nivolumab BMS will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 60 minutes, every 2 weeks.
Maltese: Nivolumab BMS ser jingħatalek bħala infużjoni (bi dripp) ġo vina (b'mod intravenuż) tul perijodu ta' 60 minuta, kull ġimagħtejn.
English: 10 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a grey flip-off seal (aluminium).
Maltese: 10 mL ta' konċentrat f'kunjett tal-10mL (ħġieġ tat-Tip I) b'tapp (lastku tal-butyl miksi) u siġill griż li jinqala' bis-seba' (aluminju).
English: In CA209017 and CA209063, the incidence of hypersensitivity/infusion reactions was 1.6% (4/248).
Maltese: F'CA209017 u CA209063, l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva/għall-infużjoni kienet 1.6% (4/248).
English: For Grade 2 (symptomatic) pneumonitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Maltese: Għal pulmonite (sintomatika) tal-Grad 2, nivolumab għandu jitwaqqaf u l-kortikosterojdi għandhom jibdew b'doża ta' 1 mg/kg/kuljum ta' ekwivalenti ta' methylprednisolone.
English: Neutralising antibodies were detected in only 5 (1.0% of the total) of the positive anti-product-antibody patients.
Maltese: Antikorpi newtralizzanti ġew osservati biss f'5 (1.0% tat-total) pazjenti li rriżultaw pożittivi għal antikorpi kontra l-prodott.
English: Patients should be monitored for signs and symptoms of hepatitis such as transaminase and total bilirubin elevations.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sintomi u sinjali ta' epatite bħal żieda fit-transaminasi u fil-bilirubina totali.
English: Persistent diarrhoea or colitis should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Maltese: Dijarea jew kolite persistenti għanda tiġi ġestita b'kortikosterojdi f'doża ta' 0.5 sa 1 mg/kg/kuljum f'ekwivalenti ta' methylprednisolone.
English: The observed OS benefit was consistently demonstrated across subgroups of patients.
Maltese: Il-benefiċċju OS osservat intwera b'mod konsistenti fis-sottogruppi tal-pazjenti.
English: Nivolumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Maltese: Nivolumab għandu jitwaqqaf għal raxx ta' Grad 3 u jitwaqqaf għal kollox għal raxx ta' Grad 4.
English: Renal impairment
Maltese: Ħawwad l-infużjoni
English: Two patients, including the one patient with a Grade 3 case (tubulointerstitial nephritis), received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 0.8 mg/kg (range: 0.5-1.2) for a median duration of 5.3 weeks (range: 0.9-9.7).
Maltese: Żewġ pazjenti, inkluż il-pazjent b'każ ta' Grad 3 (nefrite tubulointerstizjali), ingħataw kortikosterojdi b'doża għolja (tal-inqas 40 mg ta' ekwivalenti għall-prednisone) f'doża inizjali medjana ta' 0.8 mg/kg (medda: 0.5-1.2) għal tul medju ta' 5.3 ġimgħat (medda: 0.9-9.7).
English: The recommended dose of Nivolumab BMS is 3 mg/kg administered intravenously over 60 minutes every 2 weeks.
Maltese: Id-doża rrakkomandata ta' Nivolumab BMS hija ta' 3 mg/kg mogħtija ġol-vina għal 60 minuta kull ġimagħtejn.
English: Three patients, including the one patient with Grade 3 adrenal insufficiency, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 1.1 mg/kg (range: 0.5-1.3) for 2.7 weeks (range: 0.6-4.6).
Maltese: Tliet pazjenti, inkluż il-pazjent b'insuffiċjenza adrenali ta' Grad 3, ingħataw kortikosterojdi b'doża għolja (tal-inqas 40 mg ta' ekwivalenti għall-prednisone) f'doża inizjali medjana ta' 1.1 mg/kg (medda: 0.5-1.3) għal 2.7 ġimgħat (medda: 0.6-4.6).
English: The recommended dose is 3 mg of nivolumab per kilogram of your body weight.
Maltese: Id-doża rrakkomandata hija ta' 3 mg ta' nivolumab għal kull kilogramma tal-piż tal-ġisem tiegħek.
English: Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PDL1 positive (tumour membrane expression cut off of 1%, 5% or 10%).
Maltese: Il-benefiċċju tassopravivenza ġie osservat irrispettivament minn jekk il-pazjenti kellhomx tumuri li kienu kklassifikati bħala PD-L1 negattivi jew PD-L1 pożittivi (cut off għall-espressjoni tal-membrana tat-tumur ta' 1%, 5% jew 10%).
English: Nivolumab BMS must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment.
Maltese: Nivolumab BMS irid jingħata bir-reqqa f'pazjenti b'indeboliment tal-fwied moderat (bilirubina totali > 1.5 × sa 3 × il-limitu superjuri tan-normal [ULN] u kwalunkwe AST) jew sever (bilirubina totali > 3 × ULN u kwalunkwe AST).
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, diabetes mellitus, and diabetic ketoacidosis have been observed with nivolumab treatment.
Maltese: Ġew osservati endokrinopatiji, li jinkludu ipotirojdiżmu, ipertirojdiżmu, insuffiċjenza adrenali severa ipofiżite, dijabete mellitus, u ketoaċidożi dijabetika b'kura b'nivolumab.
English: Nivolumab is a human monoclonal antibody, as such pharmacokinetic interaction studies have not been conducted.
Maltese: Nivolumab huwa antikorp monoklonali uman minħabba li studji ta' interazzjoni farmakokinetika bħal dawn ma sarux.
English: The Kaplan-Meier curves for OS are shown in Figure 1.
Maltese: Il-kurvi Kaplan-Meier għal OS qed jintwerew f'Figura 1.
English: Your doctor may give you other medicines in order to prevent complications and reduce your symptoms,
Maltese: jagħtik mediċini oħra sabiex jiġu evitati kumplikazzjonijiet u jonqsu s-sintomi tiegħek,
English: The remaining offspring of nivolumab-treated females survived to scheduled termination, with no treatment-related clinical signs, alterations to normal development, organ-weight effects, or gross and microscopic pathology changes.
Maltese: L-ulied li fadal tan-nisa kkurati b'nivolumab baqgħu jgħixu sat-terminazzjoni skedata, mingħajr ebda sinjal kliniku, alterazzjoni fl-iżvilupp normali, effetti fuq il-piż tal-organi, jew bidla grossa u mikroskopika fil-patoloġija marbutin mal-kura.
English: As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of nivolumab.
Maltese: Peress li l-antikorpi monoklonali mhumiex immetabolizzati minn enzimi taċ-ċitokroma P450 (CYP) jew enzimi oħrajn li jimmetabolizzaw il-mediċini, l-inibizzjoni jew l-induzzjoni ta' dawn l-enzimi minn prodotti mediċinali koamministrati oħrajn mhix antiċipata li jaffettwa l-farmakokinetika ta' nivolumab.
English: Median time to onset was 8.1 weeks (range: 0.3-51.9).
Maltese: Il-medjan taż-żmien għall-bidu kien ta' 8.1 ġimgħat. 0.3-51.9).
English: One vial of 10 mL contains 100 mg of nivolumab.
Maltese: Kull kunjett ta' 10 mL fih 100 mg nivolumab.
English: For symptomatic adrenal insufficiency, nivolumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Maltese: Għal insuffiċjenza adrenali sintomatika, nivolumab għandu jitwaqqaf, u għandha tinbeda sostituzzjoni fiżjoloġika tal-kortikosterojdi skont kif ikun meħtieġ.
English: Grade 2 and Grade 3 cases were reported in 2.8% (7/248) and 1.6% (4/248) of patients, respectively.
Maltese: Każijiet ta' Grad 2 u Grad 3 ġew irrapportati f'2.8% (7/248) u 1.6% (4/248) talpazjenti, rispettivament.
English: BATCH NUMBER Lot
Maltese: KARTUNA TA' BARRA
English: Eleven patients received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 1.1 mg/kg (range: 0.5-4.0) for a median total duration of 4.3 weeks (range: 0.6-13.1).
Maltese: Ħdax-il pazjent ingħataw kortikosterojdi b'doża għolja (tal-inqas 40 mg ta' ekwivalenti għall-prednisone) f'doża inizjali medjana ta' 1.1 mg/kg (medda: 0.5-4.0) għal tul medju totali ta' 4.3 ġimgħat (medda: 0.6-13.1).
English: The Grade 3 case required permanent discontinuation of nivolumab.
Maltese: Il-każ ta' Grad 3 kellu bżonn ta' twaqqif permanenti ta' nivolumab.
English: Mannitol (E421)
Maltese: TWISSIJA(IET) SPEĊJALI
English: In CA209017 and CA209063, the incidence of diarrhoea or colitis was 9.3% (23/248).
Maltese: F'CA209017 u CA209063, l-inċidenza ta' dijarea jew kolite kienet ta' 9.3% (23/248).
English: The geometric mean clearance (CL), terminal half-life, and average exposure at steady state at 3 mg/kg every 2 weeks of nivolumab were 9.5 mL/h, 26.7 days, and 75.3 µg/mL, respectively, based on a population PK analysis.
Maltese: It-tneħħija ġeometrika medja (geometric mean clearance [CL]) u l-half-life terminali, u esponiment medju fl-istat fiss ta' 3 mg/kg kull ġimagħtejn ta' nivolumab kienu 9.5 mL/h, 26.
English: s r.o.
Maltese: IL-PROVVISTA U L