FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall tumour response rate was evaluated based on modified Cheson criteria both by independent review and investigator assessment.
Maltese: Ir-rata ta' rispons totali għat-tumur ġiet stmata abbażi tal-kriterji modifikati Cheson kemm mill-analiżi indipendenti kif ukoll mill-istima tal-investigatur.
English: Therefore, administering siltuximab with CYP450 substrates that have a narrow therapeutic index has the potential to change therapeutic effects and toxicity of these medicinal products due to alteration in the CYP450 pathways.
Maltese: Għalhekk, l-għoti ta' siltuximab flimkien ma' sustrati ta' CYP450 li għandhom indiċi terapewtiċi stretti għandu l-ħila li jibdel l-effetti terapewtiċi u t-tossiċità ta' dawn il-prodotti mediċinali minħabba bidla fir-rotot ta' CYP450.
English: Renal and/or hepatic impairment
Maltese: Indeboliment tal-kliewi u/jew tal-fwied
English: The percent change from baseline in MCD-related signs and symptoms and MCD-related overall symptom score at each cycle was calculated.
Maltese: Intervall ta' kunfidenza ta' 95% għall-proporzjon ta' periklu d Rispons sħiħ għas-sintomi huwa ddefinit bħala tnaqqis ta' 100% fil-punteġġ globali tas-sintomi fil-linja bażi ta' MCD
English: A consistent treatment effect favouring siltuximab treated patients across all major secondary endpoints was shown in the hyaline vascular subgroup.
Maltese: Intwera effett konsistenti ta' kura li ffavorixxa pazjenti kkurati b'siltuximab matul l-iskopijiet kollha finali sekondarji maġġuri fis-sottigrupp ta' hyaline vaskulari.
English: Secondary efficacy endpoints
Maltese: Skopijiet sekondarji finali ta' effikaċja
English: Study 2 In addition to Study 1, efficacy data are available in patients with CD from a single arm Phase 1 study
Maltese: Barra Studju 1, dejta dwar l-effikaċja hija disponibbli f'pazjenti b'CD minn studju tal-Fażi 1 (Studju 2) b'fergħa waħda.
English: Siltuximab crossed the placenta during gestation whereby fetal serum concentrations of siltuximab at gestation day (GD) 140 were similar to maternal concentrations.
Maltese: Siltuximab għadda mill-plaċenta waqt it-tqala fejn il-konċentrazzjonijiet ta' siltuximab fis-serum tal-fetu fil-jum 140 ta' tqala (GD - gestation day) kienu jixbhu lkonċentrazzjonijiet tal-omm.
English: Select efficacy results from Study 1 in the hyaline vascular subgroup are summarised in Table 4.
Maltese: Riżultati ta' effikaċja magħżula minn Studju 1 fis-sottogrupp ta' hyaline vaskulari huma miġbura fil-qosor f'Tabella 4.
English: Powder for concentrate for solution for infusion (powder for concentrate).
Maltese: Trab għall-konċentrat għal soluzzjoni għall-infużjoni (trab għall-konċentrat).
English: Cerenia is a medicine that contains the active substance maropitant.
Maltese: Cerenia huwa mediċina li fih is-sustanza attiva maropitant.
English: This summary was last updated in April 2015.
Maltese: April 2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cerenia on 29/09/2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha lil Cerenia fid-29/09/2006.
English: It is available as tablets (16, 24, 60 and 160 mg) for dogs, and as a solution for injection (10 mg/ml) under the skin or into a vein for dogs and cats.
Maltese: Jiġi bħala pilloli (16 mg, 24 mg, 60 mg and 160 mg) għall-klieb u f'soluzzjoni għal titqiba taħt il-ġilda (10 mg/ml) għall-klieb u l-qtates.
English: What is Cerenia?
Maltese: X'inhu Cerenia?
English: Cerenia blocks neurokinin-1 (NK1) receptors, which are found on the surface of certain cells in the part of the brain that controls nausea and vomitingand are activated by the attachment of a chemical in the body called ‘substance P'.
Maltese: Cerenia jimblokka r-riċetturi tan-neurokinin 1 (NK1), li jinsabu fil-wiċċ ta' ċerti ċelloli fil-parti tal-moħħ li jikkontrolla n-nawżja u r-remettar u huma attivati bit-twaħħil ta' kimika fil-ġisem imsejħa 'Sustanza P'.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (parti wkoll mill-EPAR).
English: Why has Cerenia been approved?
Maltese: Għaliex ġie approvat Cerenia?
English: Dogs:
Maltese: Klieb:
English: Only one out of 16 dogs given Cerenia vomited after receiving morphine, whilst 14 out of 15 dogs given placebo vomited, and in this group, nine of the dogs that vomited did so more than once.
Maltese: Kelb biss minn 16 li ngħata Cerenia rremetta wara li ngħata l-morfina, filwaqt li 14 minn 15-il kelb li ngħataw il-plaċebo rremettew, u f'dan il-grupp, disa' mill-klieb li rremettew, irremettew iktar minn darba.
English: For the prevention of vomiting, Cerenia was studied in dogs which received either Cerenia or a placebo (a dummy tablet or injection) before another substance known to trigger vomiting (such as certain cancer medicines) was given to them.
Maltese: Kwantu għall-prevenzjoni tar-remettar, Cerenia ġie studjat fuq klieb li ngħataw Cerenia jew plaċebo (pillola finta jew titqiba mingħajr l-ebda sustanza attiva) qabel ma ngħataw sustanza oħra li tqabbad ir-remettar (bħal dawk użati fil-mediċini ta' ċerti kanċers).
English: Other reported side effects were decreased activity levels and tiredness.
Maltese: Xi effetti sekondarji oħrajn kienu tnaqqis fil-livelli tal-attività u għejja.
English: Dogs were treated with either 1 mg/kg (injection given under the skin) or 2 mg/kg (tablet) once daily up to five days.
Maltese: Il-klieb ġew ikkurati b'1 mg/kg (titqiba) jew b'2 mg/kg (pillola) darba kuljum sa ħamest ijiem.
English: What is the risk associated with Cerenia?
Maltese: X'inhu r-riskju assoċjat ma' Cerenia?
English: Handling Cerenia does not represent a particular risk for people.However, maropitant can produce short lived eye irritation and in the case of accidental eye exposure, the eyes should be flushed with plenty of water and medical attention sought.
Maltese: Madankollu, il-maropitant jista' jipproduċi irritazzjoni fl-għajn għal ftit ħin u f'każ ta' esponiment fl-għajnejn, l-għajnejn għandhom jitlaħalħu b'ħafna ilma u minnufih għandha titfittex attenzjoni medika.
English: Dogs received either Cerenia soluton for injection or placebo 45 minutes before the administration of morphine for sedation and pain relief prior to anaesthesia .
Maltese: Il-klieb ingħataw jew is-soluzzjoni għal injezzjoni ta' Cerenia inkella plaċebo 45 minuta qabel ingħataw il-morfina għall-irqad u t-taffija tal-uġigħ qabel l-anestesija.
English: Cerenia is used to prevent (tablets and solution for injection) and treat (solution for injecton) nausea caused by chemotherapy in dogs.
Maltese: Cerenia jintuża fil-prevenzjoni (pilloli u soluzzjoni għall-injezzjoni) u l-kura (soluzzjoni għallinjezzjoni) tan-nawżja kkawżata minn kimoterapija fil-klieb
English: Cerenia tablets are given to dogs at a dose of 2 mg maropitant per kg bodyweight once daily to prevent or treat vomiting for up to 14 days.
Maltese: Il-pilloli ta' Cerenia jingħataw lill-klieb f'doża ta' 2 mg ta' maropitant għal kull kg tal-piż korporju darba kuljum biex jipprevjeni jew jikkura r-remettar sa mhux aktar minn 14-il jum.
English: For the prevention of vomiting, Cerenia was studied in cats which received either Cerenia or placebo before another substance known to trigger vomiting was given to them.
Maltese: Kwantu għall-prevenzjoni tar-remettar, Cerenia ġie studjat fi qtates li ngħataw Cerenia jew plaċebo qabel ma ngħataw sustanza oħra li tqabbad ir-remettar.
English: In the study looking at the effect of Cerenia before and after surgery, Cerenia was effective at preventing vomiting asociated with the use of morphine.
Maltese: Fl-istudju li ffoka fuq l-effett ta' Cerenia qabel u wara l-intervent kirurġiku, Cerenia kien effettiv filprevenzjoni tar-remettar assoċjat mal-użu tal-morfina.
English: A large number of studies with Cerenia were carried out either in laboratory dogs and cats or in animal patients at veterinary practices in several European countries and in the USA.
Maltese: Sar għadd kbir ta' studji fuq Cerenia fi klieb u fi qtates f'laboratorji jew f'annimali pazjenti fi kliniċi veterinarji f'diversi bliet fl-Ewropa u fl-Istati Uniti.
English: The animals received either Cerenia tablets at a dose of 8 mg/kg bodyweight or a placebo for up to two consecutive days.
Maltese: Effett sekondarju komuni tal-pilloli li ntużaw f'dożi għoljin ta' 8 mg/kg fil-klieb (kontra l-ħass ħażin miċċaqliq) kien remettar qabel beda l-vjaġġ bil-karozza.
English: For the treatment of vomiting, the effect of Cerenia (or a placebo) was examined in sick dogs that were vomiting for various reasons, for example because of a gastrointestinal infection.
Maltese: Kwantu għall-kura tar-remettar, l-effett ta' Cerenia (jew plaċebo) ġie eżaminat fi klieb morda li kienu qed jirremettu minħabba diversi raġunijiet, bħal infezzjoni gastrointestinali.
English: How has Cerenia been studied?
Maltese: Kif ġie studjat Cerenia?
English: Cerenia solution for injection is used in dogs both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine.
Maltese: Studju ieħor involva l-klieb u ffoka fuq il-prevenzjoni tan-nawżja u r-remettar qabel u wara intervent kirurġiku.
English: Cerenia tablets are given to dogs at a dose of 8 mg maropitant per kg bodyweight once daily to prevent vomiting due to motion sickness for a maximum of two consecutive days.
Maltese: L-annimali ngħataw pilloli ta' Cerenia f'doża ta' 8 mg/kg piż tal-ġisem jew inkella plaċebo sa perjodu massimu ta' jumejn konsekuttivi.
English: The active substance in Cerenia, maropitant, is broken down in the liver and therefore it is recommended to be used with caution in animals with liver disease.
Maltese: Is-sustanza attiva f'Cerenia, il-maropitant, titkisser mill-fwied u għaldaqstant huwa rrakomandat li lmediċina tingħata bi prudenza lill-annimali li jkollhom xi mard fil-fwied.
English: Invented name Strength
Maltese: Numru ta' l-EU Isem inventat Qawwa
English: Further information on Dectova can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dectova.
Maltese: ema.europa.eu/medicines/human/EPAR/dectova.
English: Other information about Dectova
Maltese: Informazzjoni oħra dwar Dectova
English: Dectova is given as an infusion (drip) into a vein.
Maltese: Dectova jingħata bħala infużjoni (dripp) ġol-vina.
English: The recommended dose for adults is 600 mg twice daily for 5 to 10 days while for children the dose is adjusted based on weight.
Maltese: Id-doża rakkomandata għall-adulti hija 600 mg darbtejn kuljum għal 5 sa 10 ijiem filwaqt li għat-tfal id-doża hija aġġustata skont il-piż.
English: Dectova has been shown to work as well as Tamiflu (the standard of care for complicated flu) in one main study involving 626 patients who had been hospitalised.
Maltese: Dectova ntwera li jaħdem tajjeb daqs Tamiflu (l-istandard tal-kura għal influwenza kkumplikata) fi studju ewlieni wieħed li involva 626 pazjent li kienu ddaħħlu l-isptar.
English: What are the risks associated with Dectova?
Maltese: X'inhuma r-riskji assoċjati ma' Dectova?
English: Dectova contains the active substance zanamivir.
Maltese: Dectova fih is-sustanza attiva żanamivir.
English: Dectova is an antiviral medicine used to treat complicated and potentially life-threatening influenza (flu) caused by either the influenza A or B virus in adults and children from 6 months of age.
Maltese: Dectova huwa mediċina antivirali li tintuża għall-kura ta' influwenza kkumplikata u li potenzjalment tista' tkun ta' theddida għall-ħajja kkawżata mill-virus tal-influwenza A jew B fl-adulti u fit-tfal minn 6 xhur 'il fuq.
English: What information is still awaited for Dectova?
Maltese: Liema informazzjoni għadha mistennija għal Dectova?
English: Lower doses are given to adults and children with reduced kidney function.
Maltese: Dożi aktar baxxi jingħataw lill-adulti u lit-tfal b'funzjoni tal-kliewi mnaqqsa.
English: Dectova works on neuraminidases of both influenza A (the most common type) and influenza B viruses.
Maltese: Dectova jaħdem fuq in-newraminidażi kemm tal-virus talinfluwenza A (it-tip l-aktar komuni) kif ukoll tal-virus tal-influwenza B.
English: The most common side effects with Dectova (which may affect up to 1 in 10 people) are diarrhoea, raised levels of transaminases (liver enzymes), liver injury and rash.
Maltese: L-effetti sekondarji l-aktar komuni b'Dectova (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma dijarea, żieda fil-livelli ta' transaminażi (enzimi tal-fwied), ħsara fil-fwied u raxx.
English: Dectova is expected to be effective against some flu strains that do not respond to other flu treatments.
Maltese: Dectova huwa mistenni li jkun effettiv kontra xi razez tal-influwenza li ma jirrispondux għal kuri oħrajn tal-influwenza.
English: As for all medicines, data on the use of Dectova are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Dectova hija ssorveljata kontinwament.
English: Evidence from laboratory and other clinical studies also supported the effectiveness of Dectova.
Maltese: Evidenza mil-laboratorju u minn studji kliniċi oħra jappoġġjaw ukoll l-effikaċja ta' Dectova.
English: The active substance in Dectova, zanamivir, prevents the flu virus from spreading by blocking some of the enzymes on the surface of the virus called neuraminidases.
Maltese: Is-sustanza attiva f'Dectova, iż-żanamivir, tipprevjeni lill-virus tal-influwenza milli jinfirex billi timblokka xi wħud mill-enzimi fuq il-wiċċ tal-virus imsejħa newraminidażi.
English: It took around 5.1 days for symptoms to resolve or patients to leave the hospital with Dectova compared with 5.6 days with Tamiflu.
Maltese: B'Dectova s-sintomi damu madwar 5.1 jiem biex jitfejqu jew biex il-pazjenti jitilqu mill-isptar meta mqabbla ma' 5.6 ijiem b'Tamiflu.
English: Since Dectova has been authorised under exceptional circumstances, the company that markets the medicine will conduct two observational studies in patients with complicated influenza to obtain further data on the effectiveness.
Maltese: Minħabba li Dectova ġie awtorizzat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed il-mediċina fis-suq se twettaq żewġ studji ta' osservazzjoni f'pazjenti b'influwenza kkumplikata sabiex tikseb aktar data dwar l-effikaċja.
English: The main measure of effectiveness was how long it took for patients to leave hospital or for 4 out of the following 5 flu symptoms to resolve: fever, decreased levels of oxygen in the blood, raised breathing rate, raised heart rate and abnormal blood pressure.
Maltese: Il-kejl ewlieni tal-effikaċja kien kemm damu l-pazjenti biex jitilqu mill-isptar jew kemm damu biex jitfejqu 4 minn dawn il-5 sintomi tal-influwenza li ġejjin: deni, livelli mnaqqsa ta' ossiġenu fid-demm, żieda fir-rata tat-teħid tan-nifs, żieda fir-rata tal-qalb u pressjoni tad-demm anormali.
English: The medicine is used when the virus is resistant to other flu treatments or when other antiviral treatments, including inhaled zanamivir are not suitable for the patient.
Maltese: Il-mediċina tintuża meta l-virus ikun reżistenti għal kuri oħrajn tal-influwenza jew meta kuri antivirali oħrajn, inkluż iż-żanamivir inalata ma jkunux adegwati għall-pazjent.
English: However, because uncertainties remain about the size of the effect of Tamiflu (and by extension the size of Dectova's effect), Dectova has been authorised under ‘exceptional circumstances'.
Maltese: Madankollu, minħabba li għad hemm inċertezzi dwar id-daqs tal-effett ta' Tamiflu (u b'estensjoni ta' dan, id-daqs tal-effett ta' Dectova), Dectova ġie awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni'.
English: Although Tamiflu was used as the comparator, there is some uncertainty about how effective this medicine is in complicated influenza as it has not been compared with placebo (a dummy treatment) in hospitalised influenza patients.
Maltese: Għalkemm Tamiflu ntuża bħala komparatur, hemm xi inċertezza dwar kemm hi effettiva din il-mediċina f'influwenza kkumplikata peress li ma tqabblitx ma' plaċebo (kura finta) f'pazjenti bl-influwenza li ddaħħlu l-isptar.
English: How does Dectova work?
Maltese: Kif jintuża Dectova?
English: What measures are being taken to ensure the safe and effective use of Dectova?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Dectova?
English: Notes:
Maltese: Noti:
English: “Paediatric patients
Maltese: “Pazjenti pedjatriċi
English: Section 4.1 (Indication):
Maltese: Taqsima 4.1 (Indikazzjoni):
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©.EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©.
English: Section 4.2 (Posology):
Maltese: Taqsima 4.2 (Pożoloġija):
English: The CHMP appointed Dr. Broich (DE) as Rapporteur and Dr. Prieto (ES) as CoRapporteur.
Maltese: Is-CHMP ħatar lil Dr. Broich (DE) bħala Rapporteur u lil Dr. Prieto (ES) bħala Ko-Rapporteur.
English: This is equivalent to 0.1 ml/kg BW of the 1.0 M solution”.
Maltese: Dan hu ekwivalenti għal 0.1 ml/kg BW tassoluzzjoni tal-1.0 M ”.
English: Gadograf/Gadovist International Non-Proprietary Name (INN): Gadobutrol
Maltese: Gadograf/Gadovist Isem Internazzjonali
English: Gadovist/Gadograf 1.0 mmol/ml contains gadobutrol, a neutral macrocyclic gadolinium (Gd) complex with contrast-enhancing properties, which is used for magnetic resonance imaging (MRI).
Maltese: Gadovist/Gadograf 1.0 mmol/ml fih gadobutrol, kumpless newtrali makroċikliku ta' gadolinju (Gd) b'karatteristiċi li jsaħħu l-kuntrast, użat għall-ħruġ ta' immaġni bir-reżonanza manjetika (MRI).
English: After finalisation of the procedure the Spanish Agency for Medicines and Health Products initiated a referral for arbitration to the CHMP under article 36.1 of Directive 2001/83/EC.
Maltese: Wara t-tmiem tal-proċedura l-Aġenzija Spanjola għall-Mediċini u għall-Prodotti tas-Saħħa bdiet riferiment għal arbitraġġ lis-CHMP skond l-Artikolu 36.1 tadDirettiva 2001/83/KE.
English: BACKGROUND INFORMATION*
Maltese: TAGĦRIF TA' SFOND*
English: Concerns were further raised with regards to the Paediatric Indication and the use of the comparator Magnevist.
Maltese: Tqajjem tħassib ukoll dwar l-Indikazzjoni Pedjatrika u dwar l-użu tal-komparatur Magnevist.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 36(1) REFERRAL
Maltese: IL-KUMITAT GĦALL-PRODOTTI MEDIĊINALI GĦAL UŻU MILL-BNIEDEM OPINJONI WARA RIFERIMENT SKOND L-ARTIKOLU 36(1)
English: Gadovist/Gadograf was approved for “Contrast enhancement in cranial and spinal magnetic resonance imaging” in Germany in January 2000 and subsequently in June 2000 in the EU and Norway via the mutual recognition procedure (MRP).
Maltese: Gadovist/Gadograf kien approvat għal "Tisħiħ tal-kuntrast fl-immaġini bir-reżonanza manjetika (MRI) tal-kranju u tas-sinsla” fil-Ġermanja f'Jannar 2000 u sussegwetament f'Ġunju 2000 fl-UE u fin-Norveġja permezz tal-proċedura ta' rikonoxximent reċiproku (MRP).
English: Having considered the grounds for the referral triggered by Spain, the CHMP, during its May 2006 plenary meeting, adopted a List of Questions and a TT for a referral procedure under Article 36.
Maltese: Wara li kkunsidra r-raġunijiet għar-riferiment imressaq minn Spanja is-CHMP, waqt il-laqgħa plenarja tiegħu ta' Mejju ta' l-2006 adotta Lista ta' Mistoqsijiet u TT għall-proċedura tarriferiment skond l-Artikolu 36.
English: A label extension to the indication “Contrast-enhanced Magnetic resonance angiography” (CE-MRA) followed in November
Maltese: Wara dan kien hemm estensjoni tat-tikketta għall-indikazzjoni “Anġografija birreżonanza Manjetika imsaħħa bil-kuntrast” (CE-MRA) f'Novembru.
English: In June 2005, a MR procedure started for a type II variation to add the indication of “Contrast enhanced MRI of other body regions: liver, kidneys” and the following posology and method of administration/dosage: “CE-MRI of other body regions: The recommended dose for adults is 0.1 mmol per kilogram body weight (mmol/kg BW).
Maltese: F'Ġunju ta' l-2005, inbdiet proċedura ta' rikonoxximent reċiproku għal varjazzjoni tat-tieni tip biex tiżdied l-indikazzjoni ta' “MRI imsaħħaħ bil-kuntrast għal partijiet oħra tal-ġisem: ilfwied, il-kliewi” u l-pożoloġija u l-metodu ta' amministrazzjoni/doża li ġejjin: “CE-MRI ta' partijiet oħra tal-ġisem:
English: The Applicant was asked to justify the choice of this comparator and the clinical utility of Gadovist/Gadograf with respect to diagnostic thinking, therapeutic management and clinical outcome.
Maltese: L-Applikant intalab jiġġustifika l-għażla ta' dan il-komparatur u l-utilità klinika ta' Gadovist/Gadograf fir-rigward tal-ħsieb dijanjostiku, tal-ġestjoni terapewtika u tar-riżultat kliniku.
English: Gadograf is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Maltese: Gadograf mhux rakkomandat għall-użu f'pazjenti ta' taħt it-18-il sena minħabba nuqqas ta' dejta fuq l-effikaċja u s-sigurtà.
English: Magnevist is not approved "to classify focal lesions [of liver or kidney] as benign or malignant" throughout the EU and it was questioned whether it would support the granting of an indication for which Magnevist has not been approved.
Maltese: Magnevist mhux approvat biex "jikklassifika l-leżjonijiet fokali [tal-fwied jew tal-kliewi] bħala beninji jew malinji" madwar l-UE u saret mistoqsija lill-UE jekk hija kinitx se tappoġġja l-għoti ta' indikazzjoni fl-UE kollha li għaliha Magnevist ma kienx ġie approvat.
English: “Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant”.
Maltese: “MRI tal-fwied u tal-kliewi msaħħaħ bil-Kuntrast f'pazjenti li jkollhom evidenza jew suspett kbir ta' leżjonijiet fokali biex jikklassifika dawn il-leżjonijiet fokali bħala beninji jew malinji”.
English: The questions identified pertained to insufficient data on the evaluation of disseminated liver disease that could justify an extrapolation to the general population undergoing examinations of liver and kidney.
Maltese: Il-kwistjonijiet identifikati kellhom x'jaqsmu ma' dejta insuffiċjenti fuq l-evalwazzjoni ta' mard tal-fwied disseminat li jista' jiġġustifika estrapolazzjoni għall-popolazzjoni ġenerali li jkunu qed isirulha eżamijiet tal-fwied u tal-kliewi.
English: In its response the Applicant addressed the issue of clinical utility by comparing Gadovist-enhanced with Magnevistenhanced MRI and underlined the diagnostic efficacy of Gadovist/Gadograf.
Maltese: Fit-tweġiba tiegħu, l-Applikant indirizza l-kwistjoni ta' lutilità klinika billi qabbel MRI imsaħħaħ b'Gadovist ma' MRI imsaħħaħ b'Magnevist u saħaq dwar l-effikaċja dijanjostika ta' Gadovist/Gadograf.
English: 500 mg Powder for concentrate for solution for infusion
Maltese: 500mg Trab għal konċentrat għal soluzzjoni għallinfużjoni użu għal ġol-vini kunjett (ħġieġ)
English: Strength Pharmaceutical Form Route of Administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata
English: Intravenous use vial (glass)
Maltese: Il-pakkett li jmiss malprodott
English: Invented name Strength Pharmaceutical Form Route of administration
Maltese: Isem inventat Qawwa Għamla Farmaċewtika
English: Packaging Package size
Maltese: Daqs talpakkett
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/153044/2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 ta' Marzu 2018 EMA/153044/2018
English: • Alternative treatment options are available.
Maltese: • Hemm disponibbli għażliet ta' kura alternattiva.