FrancophonIA/ELRC3.0 huggingface dataset:
English: This occurred within one hour of the first infusion and was reversed within 30 minutes after the inhalation of nitric oxide.
Maltese: Dan kien ikkurat fi żmien tletin minuta b'teħid bin-nifs ta' nitric oxide.
English: If after the second course of treatment, the ductus arteriosus is still not closed, a surgery may then be proposed.
Maltese: Jekk wara t-tieni kors ta' kura, id-ductus arteriosus ma jkunx għadu għalaq, allura tista' tiġi proposta operazzjoni.
English: If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Maltese: Jekk ikun hemm bżonn, il-volum ta' l-injezzjoni jista' jiġi mibdul jew b'soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride għall-injezzjoni jew soluzzjoni ta' 50 mg/ml (5%) ta' glukożju għall-injezzjoni.
English: Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professional.
Maltese: Pedea ser jingħata biss fit-taqsima ta' kura intensiva ta' trabi li għadhom kif twieldu minn professjonista kkwalifikat fil-kura tas-saħħa.
English: In preterm newborn infants less than 27 weeks of gestational age, the closure rate of the ductus arteriosus (33 to 50%) was shown to be low at the recommended dose regimen (see section 5.1).
Maltese: Fi trabi tat-twelid li twieldu qabel iż-żmien u li għandhom anqas minn 27 ġimgħa ta' ġestazzjoni, irrata ta' għeluq tad-ductus arteriosus (33 sa 50%) intwera li hu inqas bil-kors tad-doża rakkomandata (ara sezzjoni 5.1).
English: Pedea is supplied in packs of 4 x 2 ml ampoules.
Maltese: Soluzzjoni ta' 2 ml f'kunjett tal-ħġieġ bla kulur ta' tip I. Pedea ssibu f'pakketti ta' 4 kunjetti x 2 ml.
English: The concomitant use of Pedea with the following medicinal products is not recommended: - diuretics: ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients.
Maltese: - dijuretiċi: ibuprofen jista' jnaqqas l-effett ta' dijuretiċi; dijuretiċi jistgħu jżidu r-riskju ta' nefrotossiċità ta' NSAIDs f'pazjenti deidratati.
English: This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Maltese: Dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħrajn ħlief soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride soluzzjoni għall-injezzjoni jew 50 mg/ml (5%) soluzzjoni ta' glukożju.
English: A course of therapy is defined as three intravenous injections of Pedea given at 24-hour intervals.
Maltese: Kors ta' terapija jfisser tliet injezzjonijiet ġol-vina ta' Pedea mogħtija f'intervalli ta' 24 siegħa.
English: - your baby may be given corticosteroids to prevent inflammation.
Maltese: - it-tarbija tiegħek tista' tingħata kortikosterojdi sabiex tiġi evitata l-infjammazzjoni.
English: Ref. EMEA/307582/2009 EMEA/H/C/895
Maltese: EMEA/307582/2009 EMEA/H/C/895
English: London, 29 May 2009 Doc.
Maltese: Londra, 29 ta' Mejju 2009 Dok. ta' Ref.
English: What is Lunivia?
Maltese: X'inhu Lunivia?
English: Lunivia is a medicine that contains the active substance eszopiclone.
Maltese: Lunivia huwa mediċina li fiha s-sustanza attiva eszopiclone.
English: It is a purified form of one of the two ‘enantiomers' (mirror-image forms) of the substance zopiclone.
Maltese: Hija forma purifikata ta' wieħed miż-żewġ ‘enantijomeri' (immaġni identika) tas-sustanza zopiclone.
English: The active substance in Lunivia, eszopiclone, belongs to a group of medicines that are related to the benzodiazepines.
Maltese: Is-sustanza attiva f'Lunivia, eszopiclone, tappartjeni għal grupp ta' mediċini li huma relatati malbenzodijazepini (benzodiazepines).
English: It activates receptors in the brain called gamma-aminobutyric acid A (GABA-A) receptors, which are involved in bringing about sleep.
Maltese: Jaħdem billi jaġixxi fuq ir-riċetturi tal-aċidu gamma-aminobutiriku (gamma-aminobutyric ) A (GABA-A), involuti meta persuna jaqbadha n-ngħas.
English: The studies looked at ‘transient' insomnia (in this case, insomnia caused by spending a night in an unfamiliar setting), at primary insomnia (insomnia with no other cause) and at insomnia caused by other conditions (major depression, generalised anxiety disorder, the menopause and rheumatoid arthritis).
Maltese: L-istudji ħarsu lejn insonnja ‘tranżitorja' (f'dan il-każ, insonnja kkawżata milli wieħed iqatta' lejl f'post mhux familjari), f'insonnja primarja (insonnja li ma għandhiex kawża oħra) u insonnja kkawżata minn kundizzjonijiet oħrajn (depressjoni qawwija, disturb tal-ansjetà ġeneralizzat, il-menopawża u l-artrite rewmatojde).
English: All of the studies compared Lunivia with placebo (a dummy treatment).
Maltese: L-istudji kollha qabblu Lunivia ma' plaċebo (trattament finta).
English: The evaluation had finished and the CHMP had given a positive opinion.
Maltese: L-evalwazzjoni waslet fi tmiemha u s-CHMP kien ħareġ opinjoni negattiva.
English: As a consequence, Lunivia would not have been able to benefit from 10 years of ‘market exclusivity'.
Maltese: Bħala konsegwenza, Lunivia ma kienx ikun jista' jibbenefika minn 10 snin ta' ‘esklussività fuq is-suq'.
English: Questions and answers on the withdrawal of the marketing authorisation application for Lunivia eszopiclone
Maltese: Mistoqsija u tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Lunivia eszopiclone
English: Although it is chemically different from the benzodiazepines, eszopiclone acts on the same receptors in the brain.
Maltese: Minkejja li kimikament differenti mill-benzodijazepini, eszopiclone jaġixxi fuq l-istess riċetturi talmoħħ.
English: What was Lunivia expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Lunivia?
English: Zopiclone has been available in the European Union (EU) as a treatment for insomnia since the mid-1980s.
Maltese: Zopiclone ilu disponibbli fl-Unjoni Ewropea (UE) għattrattament tal-insonnja min-nofs is-snin tmenin.
English: On 13 May 2009, Sepracor Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lunivia, for the treatment of insomnia.
Maltese: Fit-13 ta' Mejju 2009, Sepracor Ltd. uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Lunivia, għat-trattament tal-insonnja.
English: The effects of Lunivia were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Lunivia għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Lunivia was expected to be used to treat adults with insomnia, including difficulty falling asleep, waking up during the night and waking up early, usually for short periods.
Maltese: Lunivia jintuża għat-trattament tal-insonnja fl-adulti, inkluża d-diffikultà biex jorqdu, għal meta jqumu matul il-lejl jew kmieni, normalment għal perjodi qosra.
English: What are the consequences of the withdrawal for patients in clinical trials using Lunivia?
Maltese: X'inhuma l-konsegwenzi tar-rifjut għall-pazjenti fil-provi kliniċi li jkunu qed jużaw Lunivia?
English: Based on the review of the data and the company's response to the CHMP's lists of questions, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Lunivia for the treatment of insomnia.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fiżżmien l-irtirar, is-CHMP kien ta opinjoni negattiva u ma rrakkomandax li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq għal Lunivia għat-trattament tal-insonnja.
English: The company had requested a re-examination of the CHMP's opinion, but after re-examining the opinion, the Committee had confirmed its earlier opinion.
Maltese: Il-kumpanija rtirat qabel ma l-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni.
English: Florgane 300 mg/ml suspension for injection has been authorised for use in cattle as a hybrid of Nuflor 300 mg/ml solution for injection using the decentralised procedure with Germany as a reference Member State and Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxemburg, the Netherlands, Poland, Portugal, Romania, Slovakia, Spain and the United Kingdom as concerned Member States.
Maltese: Florgane 300 mg/ml sospensjoni għal injezzjoni ġie awtorizzat għall-użu fil-baqar bħala ibridu ta' Nuflor 300 mg/ml soluzzjoni għal injezzjoni permezz tal-proċedura deċentralizzata bil-Ġermanja bħala Stat Membru ta' referenza u l-Awstrija, ilBelġju, il-Bulgarija, ir-Repubblika Ċeka, id-Danimarka, Franza, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Litwanja, il-Lussemburgu, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, Spanja u r-Renju Unit bħala Stati Membri kkonċernati.
English: INN Pharmaceutical form
Maltese: INN Għamla farmaċewtika
English: Slovakia
Maltese: Slovakkja
English: Florfenicol is structurally related to thiamphenicol and has a similar pharmacological profile.
Maltese: Florfenicol huwa strutturalment relatat ma' thiamphenicol u għandu profil farmakoloġiku simili.
English: France1
Maltese: Franza1
English: • it is considered there is no increase in the risk of development of antimicrobial resistance;
Maltese: • huwa meqjus li ma hemm l-ebda żieda fir-riskju ta' żvilupp ta' reżistenza antimikrobika;
English: The product is presented in four multidose vial sizes of 50 ml, 100 ml, 250 ml and 500ml.
Maltese: Il-prodott jiġi ppreżentat f'erba' daqsijiet ta' kunjetti b'bosta dożi ta' 50 ml, 100 ml, 250 ml u 500ml.
English: Spain1
Maltese: Spanja1
English: Lithuania
Maltese: Litwanja
English: Benefit-risk assessment
Maltese: Evalwazzjoni tar-riskju
English: The application in question, submitted via the decentralised procedure, is a so called “hybrid application” according to Article 13(3) of Directive 2001/82/EC.
Maltese: L-applikazzjoni in kwistjoni, sottomessa permezz tal-proċedura deċentralizzata, hija hekk imsejħa “applikazzjoni ibrida” skont l-Artikolu 13(3) tad-Direttiva 2001/82/KE.
English: The reference product was Nuflor Swine Injectable Solution 300 mg/ml.
Maltese: Il-prodott ta' referenza kien Nuflor Swine Injectable Solution 300 mg/ml.
English: The reference veterinary medicinal product is Nuflor Swine Injectable Solution 300 mg/ml.
Maltese: Il-prodott mediċinali veterinarju ta' referenza huwa Nuflor Swine Injectable Solution 300 mg/ml.
English: Indirect or additional benefits
Maltese: Benefiċċji indiretti jew addizzjonali
English: For the claimed bacteria species good susceptibility against florfenicol with MIC90 valules for P. multocida and A. pleuropneumoniae of 0.5 µg/ml was determined.
Maltese: Għall-ispeċi tal-batterji ddikjarata ġiet determinata suxxettibilità tajba kontra florfenicol b'valuri MIC90 għal P. multocida u A. pleuropneumoniae ta' 0.5 µg/ml.
English: Relevance of the dose for the development of antimicrobial resistance
Maltese: Rilevanza tad-doża għall-iżvilupp ta' reżistenza antimikrobika
English: In a GCP-compliant randomised blinded controlled clinical field study Florgane 300 mg/ml proved to be non-inferior in the treatment of swine respiratory disease associated with A. pleuropneumoniae and P. multocida at both single IM doses of 22.5 mg/kg and 30 mg/kg bw when compared to a control product containing 300 mg florfenicol/ml administered at a dose of 15 mg/kg bw IM twice 48 hours apart.
Maltese: Fi studju kliniku każwali, blindat, ikkontrollat fuq il-post li kien konformi mal-PKT (GCP), Florgane 300 mg/ml wera li ma kienx inferjuri fil-kura ta' mard respiratorju tal-majjali assoċjat ma' A. pleuropneumoniae u P. multocida kemm f'dożi uniċi ta' 22.5 mg/kg kif ukoll ta' 30 mg/kg tal-piż talġisem ġol-muskolu meta mqabbla ma' prodott ta' kontroll li kien fih 300 mg florfenicol/ml mgħoti f'doża ta' 15 mg/kg tal-piż tal-ġisem ġol-muskolu darbtejn 48 siegħa 'l bogħod minn xulxin.
English: Since florfenicol per definition is a time-dependent antimicrobial, T>MIC is the most appropriate pharmacokinetic/pharmacodynamic surrogate.
Maltese: Peress li skont id-definizzjoni florfenicol huwa antimikrobiku li jiddependi fuq iż-żmien, T>MIC huwa ssostitut farmakokinetiku/farmakodinamiku l-aktar xieraq.
English: Luxembourg Emdoka bvba John Lijsenstraat 16
Maltese: Lussemburgu Emdoka bvba John Lijsenstraat 16
English: Florfenicol is bacteriostatic and exerts timedependent activity.
Maltese: Florfenicol huwa batterjostatiku u jeżerċita attività li tiddependi fuq iż-żmien.
English: • the CVMP reviewed all available data submitted by the applicant to support the use of the product in the target species pigs for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol at the dose of 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection;
Maltese: • is-CVMP irreveda d-dejta kollha disponibbli ppreżentata mill-applikant biex jappoġġja l-użu tal prodott fil-majjali bħala speċi fil-mira għall-kura ta' infezzjonijiet respiratorji kkawżati minn razez ta' Actinobacillus pleuropneumoniae u Pasteurella multocida suxxettibbli għal florfenicol fid-doża ta' 22.5 mg florfenicol/kg tal-piż tal-ġisem mgħoti ġol-muskolu bħala injezzjoni unika;
English: The proposed dose is 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection.
Maltese: Id-doża proposta hija ta' 22.5 mg florfenicol/kg tal-piż tal-ġisem li tingħata ġol muskolu bħala injezzjoni unika.
English: Belgium Emdoka bvba John Lijsenstraat 16
Maltese: Il-Belġju Emdoka bvba John Lijsenstraat 16
English: Florgane 300 mg/ml suspension for injection contains florfenicol as active ingredient.
Maltese: Florgane 300 mg/ml sospensjoni għal injezzjoni fih florfenicol bħala sustanza attiva.
English: Florgane 300 mg/ml suspension for injection differs from the reference veterinary medicinal product by a single administration, a different pharmaceutical form and composition.
Maltese: Florgane 300 mg/ml sospensjoni għal injezzjoni jvarja mill-prodott mediċinali veterinarju ta' referenza minħabba għotja unika, għamla u kompożizzjoni farmaċewtika differenti.
English: Quality, Target animal safety, User safety, Environmental risk and Residues were not assessed in this referral procedure.
Maltese: Il-Kwalità, is-Sigurtà tal-annimal fil-mira, is-Sigurtà għall-utent, ir-Riskju ambjentali u r-Residwi ma ġewx evalwati f'din il-proċedura ta' riferiment.
English: However, no pharmacokinetic data of the terminal phases are available which could allow for a robust comparison between Florgane 300 mg/ml suspension for injection and conventional formulations in regard to duration of sub-therapeutic concentrations.
Maltese: Madankollu, ma hemm l-ebda dejta farmakokinetika disponibbli tal-fażijiet terminali li tista' tippermetti tqabbil robust bejn Florgane 300 mg/ml sospensjoni għal injezzjoni u formulazzjonijiet konvenzjonali fir-rigward tat-tul ta' konċentrazzjonijiet sub-terapewtiċi.
English: Florgane 300 mg/ml will not differ from the previous florfenicol formulations as far as the plasma elimination phase and sub-therapeutic periods are concerned.
Maltese: Florgane 300 mg/ml mhux se jkun differenti mill-formulazzjonijiet preċedenti ta' florfenicol safejn il-fażi tal-eliminazzjoni mill-plasma u l-perjodi sub-terapewtiċi huma kkonċernati.
English: Czech Republic Emdoka bvba John Lijsenstraat 16
Maltese: Id-Danimarka Emdoka bvba John Lijsenstraat 16
English: Based on a GLP-compliant dose titration study using pigs artificially infected with A. pleuropneumoniae two doses of florfenicol were selected for further evaluation in a clinical field study, which was supported by pharmacokinetic/pharmacodynamic analysis.
Maltese: Abbażi ta' studju ta' titrazzjoni tad-doża konformi mal-PLT (GLP) li uża majjali artifiċjalment infettati b'A. pleuropneumoniae żewġ dożi ta' florfenicol intgħażlu għal evalwazzjoni ulterjuri fi studju kliniku fuq il-post, li kien appoġġjat minn analiżi farmakokinetika/farmakodinamika.
English: Resistance
Maltese: Anness
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the clinical efficacy of Florgane 300 mg/ml suspension for injection at a single intramuscular dose of 22.5 mg/kg bw in the treatment of swine respiratory disease.
Maltese: Dan ir-riferiment skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE kien sar minħabba tħassib li lapplikant ma kienx wera b'mod sodisfaċenti l-effikaċja klinika ta' Florgane 300 mg/ml sospensjoni għal injezzjoni f'doża unika ta' 22.5 mg/kg tal-piż tal-ġisem ġol-muskolu għall-kura ta' mard respiratorju tal-majjali.
English: Evaluation and conclusion on the benefit-risk balance
Maltese: Evalwazzjoni u konklużjoni dwar il-bilanċ tal-benefiċċju-riskju
English: Pharmacokinetic data suggest that the elimination of the active ingredient is independent of the formulation and the dosage as long as the absorption phase is completed.
Maltese: Dejta farmakokinetika tissuġġerixxi li l-eliminazzjoni tas-sustanza attiva hija indipendenti mill-formulazzjoni u mid-doża sakemm il-fażi ta' assorbiment tkun kompluta.
English: Annex III
Maltese: III
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Maltese: Lista tal-isem, għamla farmaċewtika, qawwa tal-prodott veterinarju mediċinali, speċi tal-annimali, mod ta' kif jingħata, applikant fl-Istati Membri
English: This extension application was submitted as a decentralised procedure under Article 13(3) of Directive 2001/82/EC, as amended, to the above-mentioned Member States as for the initial application for cattle.
Maltese: Din l-applikazzjoni għal estensjoni ġiet sottomessa bħala proċedura deċentralizzata skont lArtikolu 13(3) tad-Direttiva 2001/82/KE, kif emendata, lill-Istati Membri msemmija hawn fuq l-istess bħall-applikazzjoni inizjali għall-baqar.
English: During the decentralised procedure potential serious risks were identified by Denmark regarding the sustained concentration above the Minimum Inhibitory Concentration (MIC) at the site of infection for the necessary duration.
Maltese: Matul il-proċedura deċentralizzata, id-Danimarka identifikat riskji serji potenzjali fir-rigward talkonċentrazzjoni sostnuta 'l fuq mill-Konċentrazzjoni Inibitorja Minima (MIC) fis-sit tal-infezzjoni għattul ta' żmien meħtieġ.
English: Considering the MIC data from most recent isolates, obtained from pigs suffering from respiratory disease in the last 5 years florfenicol exhibited consistent MICs with MIC90 ranges of 0.25-1 µg/ml for
Maltese: Meta titqies id-dejta tal-MIC mill-iżolati l-aktar reċenti, li nkisbet minn majjali li kienu jbatu minn mard respiratorju fl-aħħar 5 snin florfenicol wera MICs konsistenti b'firxiet tal-MIC90 ta' 0.25-1 µg/ml għal A. pleuropneumoniae u ta' 0.5 µg/ml għal P. multocida.
English: The overall conclusion is that that the efficacy dataset as a whole is adequate to support the efficacy of the product in target species pigs at the dose of 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Maltese: Il-konklużjoni ġenerali hija li l-ġabra tad-dejta dwar l-effikaċja hija adegwata biex tappoġġa l-effikaċja tal-prodott fil-majjali bħala speċi fil-mira fid-doża ta' 22.5 mg florfenicol/kg tal-piż tal-ġisem li jingħata ġol-muskolu bħala injezzjoni unika għall-kura ta' infezzjonijiet respiratorji kkawżati minn razez ta' Actinobacillus pleuropneumoniae u Pasteurella multocida suxxettibbli għal florfenicol.
English: Plasmid mediated resistance has only been scarcely identified among porcine respiratory pathogens without indication of spreading.
Maltese: Reżistenza medjata minn Plasmid kienet biss minimament identifikata fost il-patoġeni respiratorji talporċini mingħajr indikazzjoni ta' tixrid.
English: Resistance to florfenicol remains very low among porcine respiratory pathogens while Nuflor Swine Injectable Solution 300 mg/ml has been used for more than one decade in pigs in swine respiratory disease.
Maltese: Ir-reżistenza għal florfenicol tibqa' baxxa ħafna fost patoġeni respiratorji tal-porċini filwaqt li Nuflor Swine Injectable Solution 300 mg/ml ilu jintuża għal aktar minn għaxar snin fil-majjali f'mard respiratorju tal-majjali.
English: Assessment of the data submitted
Maltese: Evalwazzjoni tad-dejta sottomessa
English: The intended use in pigs is for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Maltese: L-użu maħsub fil-majjali huwa għall-kura ta' infezzjonijiet respiratorji kkawżati minn razez ta' Actinobacillus pleuropneumoniae u Pasteurella multocida suxxettibbli għal florfenicol.
English: The Member States concerned failed to reach an agreement in respect of the extension of the marketing authorisation of Florgane 300 mg/ml suspension for injection for cattle to the target species pigs and consequently the matter was referred to the CVMP on 19 April 2012.
Maltese: L-Istati Membri kkonċernati naqsu milli jilħqu ftehim fir-rigward tal-estensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq għal Florgane 300 mg/ml sospensjoni għal injezzjoni għall-baqar lill-majjali bħala speċi fil-mira u konsegwentement il-kwistjoni ġiet riferuta lisCVMP fid-19 ta' April 2012.
English: Swine respiratory disease is one of the most important diseases of pig production resulting from infection of susceptible pigs with virus and obligatory and facultative pathogenic bacteria, which require effective therapeutic treatment.
Maltese: Il-mard respiratorju tal-majjali huwa wieħed mill-mard l-aktar importanti tal-produzzjoni tal-majjali li jirriżulta minn infezzjoni ta' majjali suxxettibbli b'virus u batterji patoġeniċi fakultattivi u obbligatorji, li jeħtieġ kura terapewtika effettiva.
English: Further information on Opdivo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/opdivo.
Maltese: Aktar informazzjoni dwar Opdivo tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/opdivo.
English: Opdivo contains the active substance nivolumab.
Maltese: Opdivo fih is-sustanza attiva nivolumab.
English: Other information about Opdivo
Maltese: Informazzjoni oħra dwar Opdivo
English: Classical Hodgkin lymphoma
Maltese: Limfoma ta' Hodgkin klassika
English: Urothelial cancer
Maltese: Kanċer uroteljali
English: • melanoma, a type of skin cancer.
Maltese: • melanoma, tip ta' kanċer tal-ġilda.
English: After 24 months, 66.5% of patients given the combination were alive compared with 52.9% in the sunitinib group.
Maltese: Wara 24 xahar, 66.5 % tal-pazjenti li ngħataw il-kombinazzjoni kienu ħajjin meta mqabbla ma' 52.9 % fil-grupp tas-sunitinib.
English: Opdivo received a marketing authorisation valid throughout the EU on 19 June 2015.
Maltese: Opdivo rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fid-19 ta' Ġunju 2015.
English: In addition, 41.6% of patients (177 out of 423) responded to the treatment with the combination compared with 26.5% (112 out of 416) of those receiving sunitinib.
Maltese: Barra minn hekk, 41.6 % tal-pazjenti (177 minn 423) irrispondew għall-kura bil-kombinazzjoni meta mqabbla ma' 26.5 % (112 minn 416) ta' dawk li rċevew sunitinib.
English: Opdivo is also commonly associated with side effects related to the activity of the immune system on body organs.
Maltese: Opdivo ġeneralment huwa assoċjat ukoll ma' effetti sekondarji relatati mal-attività tas-sistema immunitarja fuq l-organi tal-ġisem.
English: What are the risks associated with Opdivo?
Maltese: X'inhuma r-riskji assoċjati ma' Opdivo?
English: Why is Opdivo authorised?
Maltese: Għaliex ġie approvat Opdivo?