FrancophonIA/ELRC3.0 huggingface dataset:
English: There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs.
Maltese: Hemm relazzjoni lineari bejn id-doża mogħtija u l-konċentrazzjoni fil-plażma osservata fil-firxa tad-doża terapewtika fil-klieb.
English: SPECIAL WARNINGS
Maltese: Id-Danimarka
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA' L-AWTORIZZAZZJONI
English: Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Maltese: Injezzjoni waħda ġol-vina jew taħt il-ġilda b'dożaġġ ta' 0.2 mg ta' meloxicam/kg ta' piż tal-ġisem (i.e. 0.4 ml/10 kilogrammi ta' piż tal-ġisem), qabel l-operazzjoni, pereżempju meta jkun qed jingħata lloppju.
English: Cats: Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA
English: Do not use after the expiry date stated on the carton and the vial after EXP. Shelf-life after first opening the container: 28 days.
Maltese: Tużax wara d-data ta' l-iskadenza fuq il-kartuna u l-kunjett wara EXP.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with
Maltese: Fin-nuqqas ta' studji dwar kompattibilita, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
English: Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
Maltese: Injezzjoni waħda taħt il-ġilda b'dożaġġ ta' 0.3 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 0.06 ml/kg ta' piż tal-ġisem), qabel l-operazzjoni, pereżempju meta jkun qed jingħata l-loppju.
English: Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for repeated oral administration has been established.
Maltese: Tużax terapija orali wara din li jkun fiha meloxicam jew NSAIDs oħra fil-qtates, peress li ebda doża sikura għall-għoti ripetuta mill-ħalq me ġiet stabbilita.
English: EMA/670094/2015 EMEA/H/C/002145
Maltese: EMA/H/C/002145
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Glybera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Glybera jista' jinstab fis-sit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR for Glybera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Glybera is a medicine that contains the active substance alipogene tiparvovec.
Maltese: Glybera huwa mediċina li fiha s-sustanza attiva alipogene tiparvovec.
English: This is a summary of the European public assessment report (EPAR) for Glybera.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Glybera.
English: Other common side effects reported include headache, tiredness, hyperthermia (high body temperature), contusion (bruising) and increased levels of the enzyme creatine kinase in the blood (a measure of damage to muscle tissue).
Maltese: Effetti sekondarji komuni oħrajn inkludew uġigħ ta' ras, għejja, ipertermija (temperatura għolja tal-ġisem), kontużjoni (tbenġil) u livelli ogħla tal-enzim kreatina kinażi fid-demm (kejl ta' ħsara fit-tessut tal-muskolu).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Glybera on 25 October 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Glybera fil-25 ta' Ottubru 2012.
English: Glybera is a type of advanced therapy medicine called a ‘gene therapy product'.
Maltese: Glybera huwa tip ta' mediċina ta' terapija avvanzata msejħa ‘prodott ta' terapija tal-ġeni'.
English: Because the number of patients with lipoprotein lipase deficiency is low, the disease is considered ‘rare', and Glybera was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 March 2004.
Maltese: Minħabba li l-għadd ta' pazjenti b'defiċjenza ta' lipoproteina lipażi huwa żgħir, il-marda hija kkunsidrata ‘rari', u Glybera kien ikklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fit-8 ta' Marzu 2004.
English: Glybera has been studied in 27 patients with lipoprotein lipase deficiency on a low-fat diet.
Maltese: Glybera ġie studjat f'27 pazjent b'defiċjenza ta' lipoproteina lipażi fuq dieta b'ammont baxx ta' xaħam.
English: Why has Glybera been approved?
Maltese: Għaliex ġie approvat Glybera?
English: What information is still awaited for Glybera?
Maltese: Liema informazzjoni għadha mistennija għal Glybera?
English: The active substance in Glybera, alipogene tiparvovec, is derived from a virus that has been modified so it can carry the lipoprotein lipase gene into the body's cells.
Maltese: Is-sustanza attiva fi Glybera, l-alipogene tiparvovec, tinkiseb minn virus li ġie mmodifikat sabiex ikun jista' jġorr il-ġene ta' lipoproteina lipażi fiċ-ċelloli tal-ġisem.
English: What is Glybera?
Maltese: X'inhu Glybera?
English: What is the risk associated with Glybera?
Maltese: X'inhu r-riskju assoċjat ma' Glybera?
English: Glybera must not be used in patients with immunodeficiency (weakened immunity), increased risk of bleeding and muscle disease.
Maltese: Glybera m'għandux jintuża f'pazjenti b'immunodefiċjenza (immunità dgħajfa), b'riskju akbar ta' fsada u mard tal-muskoli.
English: Glybera is given as a single treatment involving multiple injections into the muscles of the upper and lower legs.
Maltese: Glybera jingħata bħala kura singola li tinvolvi injezzjonijiet multipli fil-muskoli tan-naħa ta' fuq u ta' isfel tar-riġlejn.
English: When injected into the muscles, it corrects the lipoprotein lipase deficiency by enabling the muscle cells to produce the enzyme.
Maltese: Meta tkun injettata fil-muskoli, hija tirranġa d-defiċjenza ta' lipoproteina lipażi billi tippermetti liċ-ċelloli tal-muskoli jipproduċu l-enzim.
English: The company will also provide patients and healthcare professionals with educational materials, including information on how to administer Glybera and how to manage risks with the medicine.
Maltese: Il-kumpanija se tipprovdi wkoll lill-pazjenti u lill-professjonisti fil-kura tas-saħħa materjal edukattiv, inkluż informazzjoni dwar kif għandu jingħata Glybera u kif għandhom jiġu mmaniġġjati rriskji bil-mediċina.
English: A risk management plan has been developed to ensure that Glybera is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Glybera jintuża bl-aktar mod sigur possibbli.
English: After careful consideration of all the evidence and the circumstances of the disease, including its extreme rarity, the CHMP concluded that the results from studies showed that the benefits of Glybera outweigh its risks in patients with severe or multiple pancreatitis attacks despite following a low-fat diet.
Maltese: Wara konsiderazzjoni bir-reqqa tal-evidenza kollha u ċ-ċirkostanzi tal-marda, inkluża r-rarità estrema tagħha, is-CHMP ikkonkluda li r-riżultati mill-istudji wrew li l-benefiċċji ta' Glybera huma akbar mirriskji tiegħu f'pazjenti b'attakki severi jew multipli ta' pankreatite minkejja li jsegwu dieta b'ammont baxx ta' xaħam.
English: The modified viral material used in Glybera does not cause infections and cannot make copies of itself.
Maltese: Il-materjal virali modifikat użat fi Glybera ma jikkawżax infezzjonijiet u ma jistax jagħmel kopji tiegħu nnifsu.
English: For the full list of all side effects reported with Glybera, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtata bi Glybera, ara l-fuljett ta' tagħrif.
English: Patients will also be provided with a patient alert card.
Maltese: Din hija tip ta' mediċina li taħdem billi tittrasferixxi ġeni fil-ġisem.
English: Glybera should only be prescribed and given under the supervision of a doctor with expertise in treating lipoprotein lipase deficiency and in gene therapy.
Maltese: Glybera għandu jingħata biss b'riċetta ta' tabib u taħt is-sorveljanza ta' tabib b'esperjenza fil-kura taddefiċjenza ta' lipoproteina lipażi u fit-terapija tal-ġeni.
English: The majority of patients who received Glybera also received immunosuppressive treatment.
Maltese: Il-parti l-kbira tal-pazjenti li rċevew Glybera ngħataw ukoll kura immunosoppressiva.
English: Glybera has been authorised under ‘exceptional circumstances' as it has not been possible to obtain complete information about the medicine, because of the rarity of the disease.
Maltese: Glybera ġie awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni' għax ma kienx possibbli li tinġabar linformazzjoni kollha dwar il-mediċina, minħabba r-rarità tal-marda.
English: Glybera is used to treat adults with lipoprotein lipase deficiency who have severe or multiple attacks of pancreatitis (inflammation of the pancreas) despite maintaining a low-fat diet.
Maltese: Glybera jintuża fil-kura tal-adulti b'defiċjenza ta' lipoproteina lipażi li jkollhom attakki severi jew multipli ta' pankreatite (infjammazzjoni tal-frixa) minkejja li joqogħdu fuq dieta b'ammont baxx ta' xaħam.
English: How has Glybera been studied?
Maltese: Kif ġie studjat Glybera?
English: Under the terms of the authorisation, the company is required to provide further data on fat levels in the blood after meals and on the immune response to Glybera in new patients.
Maltese: Skont it-termini tal-awtorizzazzjoni, il-kumpanija hija meħtieġa li tipprovdi aktar data dwar il-livelli tax-xaħam fid-demm wara l-ikel u dwar ir-reazzjoni immunitarja għal Glybera f'pazjenti ġodda.
English: The company will also provide data from a registry to monitor the outcome of patients treated with Glybera, and will add a step to the manufacturing of the product to improve the safety profile.
Maltese: Ilkumpanija se tipprovdi wkoll data minn reġistru biex tissorvelja l-eżitu tal-pazjenti kkurati b'Glybera, u se żżid pass ieħor mal-manifattura tal-prodott sabiex ittejjeb il-profil tas-sigurtà.
English: For more information on the dose of Glybera to be given, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar id-doża ta' Glybera li għandha tingħata, ara ssommarju tal-karatterstiċi tal-prodott (parti wkoll mill-EPAR).
English: Lipoprotein lipase deficiency is a rare disease in which patients have a defect in the gene for lipoprotein lipase, an enzyme responsible for breaking down fats.
Maltese: Id-defiċjenza tal-lipoproteina lipażi hija marda rari li fiha l-pazjenti jkollhom difett fil-ġene għal lipoproteina lipażi , enzim responsabbli mit-tkissir tax-xaħam.
English: For three days before Glybera treatment and for twelve weeks after, patients are given immunosuppressive treatment to reduce the reaction of the body's immune system against the medicine.
Maltese: Għal tlett ijiem qabel il-kura bi Glybera u għal tnax-il ġimgħa wara, il-pazjenti jingħataw kura immunosoppressiva sabiex tonqos ir-reazzjoni tas-sistema immunitarja tal-ġisem kontra l-mediċina.
English: Due to the multiple injections required, it is advisable to give it with a spinal or regional anaesthetic (medicines which numb certain parts of the body to block pain).
Maltese: Minħabba l-injezzjonijiet multipli meħtieġa, huwa rakkomandat li dawn jingħataw b'anestetiku spinali jew reġjonali (mediċini li jraqqdu ċerti partijiet tal-ġisem biex ma jinħassx l-uġigħ).
English: The data showed a reduction in blood fat levels after meals in some patients.
Maltese: Id-data uriet tnaqqis fil-livelli tax-xaħam fid-demm wara l-ikel f'ċerti pazjenti.
English: The most common side effect reported with Glybera was pain in the legs following the injections, which occurred in a third of patients.
Maltese: L-effett sekondarju l-aktar komuni rrapportat bi Glybera kien l-uġigħ fir-riġlejn wara l-injezzjonijiet, li seħħ f'terz tal-pazjenti.
English: Unit-dose blister
Maltese: Il-pakkett li jmiss mal-prodott
English: Blister (unit-dose)
Maltese: Folja (doża waħda) 120X1 pillola
English: • QTc interval 500 msec.
Maltese: • Intervall tal-QTc 500 msek.
English: o That GILENYA is not recommended in patients with: o Second degree Mobitz Type II or higher AV block o Sick-sinus syndrome o Sino-atrial heart block o QTc prolongation >470 msec (females) or >450 msec (males) o Ischaemic cardiac disease including angina pectoris o Cerebrovascular disease o History of myocardial infarction o Congestive heart failure o History of cardiac arrest o Severe sleep apnoea o History of symptomatic bradycardia o History of recurrent syncope o Uncontrolled hypertension
Maltese: o Li GILENYA mhuwiex irrakkomandat f'pazjenti b': o Mobitz tat-Tip II tat-tieni livell jew imblokk tal-AV ogħla o Sindrome tas-sinus marid o Imblokk tal-qalb sinoatrijali o Prolungament tal-QTc >470 msek (nisa) jew ta' >450 msek (irġiel) o Mard kardijaku iskemiku inkluż angina pectoris o Mard ċelebrovaskulari o Storja ta' infart mijokardijaku o Insuffiċjenza konġestiva tal-qalb o Storja ta' arrest kardijaku o Apnea qawwija tal-irqad o Storja ta' bradikardija sintomatika o Storja ta' sinkope rinkorrenti o Pressjoni għolja mhux ikkontrollata
English: • Heart rate <45 bpm.
Maltese: • Ir-rata tat-taħbit tal-qalb <45 bpm.
English: o GILENYA may increase the risk of infections.
Maltese: o GILENYA jista' jżid ir-riskju ta' infezzjonijiet.
English: o The teratogenic risk of GILENYA: the importance of avoiding pregnancy when undergoing treatment with GILENYA and the need for a negative pregnancy test result prior to treatment initiation.
Maltese: o Ir-riskju teratoġeniku għal GILENYA: l-importanza li tkun evitata tqala waqt it-trattament b'GILENYA u l-bżonn ta' test negattiv tat-tqal qabel it-tnedija tat-trattament.
English: Continuous (real time) ECG monitoring is recommended.
Maltese: Hu rrakkomandat monitoraġġ kontinwu b'ECG (f'ħin reali).
English: o The need for liver function monitoring at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter.
Maltese: o Il-bżonn li jkun hemm monitoraġġ tal-funzjoni tal-fwied fix-xhur 1, 3, 6, 9 u 12 matul it-terapija b'GILENYA u wara minn żmien għal żmien.
English: o GILENYA is not recommended in patients concomitantly taking Class Ia or Class III antiarrhythmic medicines.
Maltese: o GILENYA mhuwiex irrakkomandat f'pazjenti li jieħdu medicine antiarritmiċi ta' Klassi
English: • Physician's checklist prior to prescribing GILENYA
Maltese: • Lista ta' affarijiet li t-tabib irid jiċċekkja qabel jikteb riċetta għal GILENYA
English: o The need for a liver function test prior to treatment initiation and for liver function monitoring at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter.
Maltese: o Il-bżonn li jkun hemm test tal-funzjoni tal-fwied qabel it-tnedija tat-trattament u tal-monitoraġġ tal-funzjoni tal-fwied fix-xhur 1, 3, 6, 9 u 12 matul it-terapija b'GILENYA u wara minn żmien għal żmien.
English: • Information about the Fingolimod Pregnancy Exposure Registry
Maltese: • Informazzjoni dwar ir-Reġistru ta' Tqaliet Esposti għal Fingolimod
English: Concomitant treatment with immunosuppressant or immune-modulating medicines should be avoided.
Maltese: Għandu jkun evitat trattament konkomitanti b'mdeiċini immunosupressanti jew immunomodulanti.
English: o The need for a full ophthalmological assessment 3-4 months after starting GILENYA therapy for the early detection of visual impairment due to drug-induced macular oedema.
Maltese: o Il-bżonn ta' evalwazzjoni kompluta oftalmoloġika 3-4 xhur wara t-tnedija tat-terapija b'GILENYA sabiex jinstabu minn kmieni sinjali ta' nuqqas ta' vista minħabb edema makulari b'rabta mal-mediċina.
English: o GILENYA reduces peripheral blood lymphocyte counts.
Maltese: o GILENYA jnaqqas l-ammonti ta' limfoċiti periferali fid-demm.
English: o The need to report immediately symptoms indicating low heart rate (such as dizziness, vertigo, nausea or palpitations) after the first dose of GILENYA.
Maltese: o Il-bżonn li jsir rapport minnufih tas-sintomi li jindikaw rata baxxa tat-taħbit tal-qalb (bħalma huma sturdament, mejt, dardir jew palpitazzjonijiet) war l-ewwel doża ta' GILENYA.
English: o Perform a liver function test prior to treatment initiation.
Maltese: o Agħmel test tal-funzjoni tal-fwied qabel ma jinbeda t-trattament.
English: Suspension of treatment during serious infections should be considered.
Maltese: Għandu jitqies twaqqif tattrattament matul infezzjonijiet.
English: o Where at the 6-hour time point:
Maltese: o Fejn malli għaddew is-6 sigħat:
English: There is a need to check the patient's peripheral lymphocyte count (CBC) prior to initiation and to monitor during treatment with GILENYA.
Maltese: Hemm bżonn li wieħed jiċċekkja l-ammont ta' limfoċiti periferali (CBC) fil-pazjenti qabel ma jinbeda t-trattament b'GILENYA u waqtu.
English: Until 6 hours after first dose (or if the last dose of GILENYA was more than two weeks previously) o Monitor the patient for 6 hours after the first dose of GILENYA has been administered for signs and symptoms of bradycardia, including hourly pulse and blood pressure checks.
Maltese: Sa 6 sigħat wara l-ewwel doża (jew jekk l-aħħar doża ta' GILENYA ngħatat aktar minn ġimagħtejn qabel) o Immonitorja l-pazjent għal 6 sigħat wara li ngħatat l-ewwel doża ta' GILENYA għal sinjali u sintomi ta' bradikardija, inkluż evalwazzjoni kull siegħa tal-polz u l-pressjoni tad-demm.
English: o Monitoring requirements at treatment initiation Before first dose o Perform baseline ECG prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
Maltese: o Kejjel il-pressjoni tad-demm qabel l-ewwel doża ta‘ GILENYA (jew meta l-aħħar doża ta‘ GILENYA kienet aktar minn ġimagħtejn qabel).
English: • Patient reminder card
Maltese: • Kartuna li tfakkar lil pazjent
English: o GILENYA is not recommended in patients with cardiac disease or those taking medicines concomitantly known to decrease heart rate and they should tell any doctor they see that they are being treated with GILENYA.
Maltese: o GILENYA mhuwiex irrakkomandat f'pazjenti li qed jieħdu flimkien medicine li huma magħrufa li jnaqqsu r-rata tat-taħbit tal-qalb.
English: If GILENYA treatment is considered in these patients anticipated benefits must outweigh potential risks and a cardiologist must be consulted to determine appropriate monitoring, at least overnight extended monitoring is recommended.
Maltese: Jekk it-trattament b'GILENYA jitqies f'dawn il-pazjenti l-benefiċċji mbassra għandhom jegħlbu r-riskji li jista' jkun hemm u wieħed għandu jikkonsulta kardjologu biex jiddetermina monitoraġġ xieraq, huwa rrakkomanda li jkun hemm għall-inqas estensjoni tal-monitoraġġ matul il-lejl.
English: The full EPAR and risk management plan summary for Nivolumab BMS can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Nivolumab BMS is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Nivolumab BMS hija antikorp monoklonali.
English: The medicine contains the active substance nivolumab.
Maltese: Il-mediċina fiha s-sustanza attiva nivolumab.
English: This is a summary of the European public assessment report (EPAR) for Nivolumab BMS.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nivolumab BMS.
English: Nivolumab BMS is a cancer medicine used to treat adults with a type of lung cancer called squamous non-small cell lung cancer (NSCLC).
Maltese: Nivolumab BMS huwa mediċina kontra l-kanċer li tintuża fil-kura ta' adulti b'tip ta' kanċer tal-pulmun imsejjaħ kanċer tal-pulmun b'ċelloli skwamużi mhux żgħar (NSCLC).
English: Nivolumab BMS is also commonly associated with side effects related to the activity of the immune system on body organs.
Maltese: Nivolumab BMS ġeneralment huwa assoċjat ukoll ma' effetti sekondarji relatati mal-attività tas-sistema immunitarja fuq l-organi tal-ġisem.
English: The average survival among 135 patients given Nivolumab BMS was around 9 months, whereas among the 137 patients given docetaxel it was 6 months.
Maltese: Is-sopravivenza medja fost 135 pazjent li ngħataw Nivolumab BMS kienet ta' madwar 9 xhur, filwaqt li fost il-137 pazjent li ngħataw docetaxel kienet ta' 6 xhur.
English: The recommended dose is 3 mg of nivolumab per kilogram body weight given into a vein over 60 minutes, every two weeks for as long as the patient continues to benefit from it. Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Maltese: Id-doża rakkomandata hija ta' 3 mg ta' nivolumab għal kull kilogramma tal-piż tal-ġisem mogħtija fil-vina għal perjodu ta' 60 minuta, kull ġimagħtejn sakemm il pazjent jibqa' jibbenefika minnha.
English: Nivolumab BMS have been shown to improve patients' survival in one main study involving 272 patients with previously treated squamous NSCLC that was advanced or had spread throughout the body.
Maltese: Nivolumab BMS intwera li jtejjeb is-sopravivenza tal-pazjenti fi studju ewlieni wieħed li involva 272 pazjent li kellhom NSCLC skwamuż ikkurat qabel li kien avvanzat jew li kien infirex mal-ġisem kollu.
English: How is Nivolumab BMS used?
Maltese: Kif jaħdem Nivolumab BMS?
English: The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms of side effects.
Maltese: Il-kumpanija ser tipprovdi wkoll kard ta' twissija b'informazzjoni dwar ir-riskji tal-mediċina għall-pazjenti, kif ukoll struzzjonijiet dwar meta għandhom jikkuntattjaw lit-tabib tagħhom jekk ikollhom sintomi ta' effetti sekondarji.
English: The antigen to which nivolumab has been designed to attach is a receptor called ‘programmed cell death-1' (PD-1), which switches off the activity of certain cells of the immune system (the body's natural defences) called T cells.
Maltese: L-antiġen li teħel miegħu n-nivolumab tfassal biex jeħel ma' u jimblokka riċettur imsejjaħ ‘mewt ipprogrammata taċ-cellola-1' ('programmed cell death-1') (PD-1), li jwaqqaf l-attività ta' ċerti ċelloli tas-sistema immunitarja (id-difiżi naturali tal-ġisem) imsejħin ċelloli T. Meta teħel ma' PD-1, innivolumab timblokka r-riċettur u tipprevenih milli jwaqqaf dawn iċ-ċelloli immunitarji.
English: The most common side effects with Nivolumab BMS (which may affect more than 1 in 10 people) are tiredness, decreased appetite, and nausea (feeling sick), which are mostly mild or moderate in severity.
Maltese: L-effetti sekondarji l-aktar komuni b'Nivolumab BMS (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma għeja, nuqqas ta' aptit, u nawżja (tħossok ma tiflaħx), li normalment huma ħfief jew
English: A risk management plan has been developed to ensure that Nivolumab BMS is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Nivolumab BMS jintuża bl-aktar mod sigur possibbli.
English: In addition, the company that markets Nivolumab BMS will provide educational packs for doctors who are expected to prescribe the medicine, containing information on how it should be used and how to manage side effects, particularly side effects related to the activity of the immune system.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Nivolumab BMS fis-suq ser tipprovdi pakketti edukattivi għat-tobba li huma mistennija jippreskrivu Nivolumab BMS, li fihom informazzjoni dwar kif għandha tintuża l-mediċina u kif għandhom jiġu ġestiti l-effetti sekondarji, b'mod partikolari effetti sekondarji relatati mal-attività tas-sistema immunitarja.