FrancophonIA/ELRC3.0 huggingface dataset:
English: Vials contain 10 ml, 50 ml or 100 ml.
Maltese: Il-kunjetti fihom 10 ml, 50 ml jew 100 ml.
English: Excipient: Ethanol
Maltese: Ethanol
English: MANUFACTURER'S BATCH NUMBER LOT {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 20 mg/ml
Maltese: TAS-SUSTANZA(I) ATTIVA Meloxicam 20 mg/ml
English: The active substance in Recocam 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Recocam 20 mg/ml soluzzjoni għall-injezzjoni għall-frat, il-majjali u ż-żwiemel hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: MARKETING AUTHORISATION NUMBERS EU/2/11/133/001-003
Maltese: EU/2/11/133/001
English: Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Maltese: Meloxicam jiġi eliminat b'half-life ta' 26 siegħa u 17.5 sigħat wara li jingħata b'injezzjoni taħt il-ġilda fi frat żgħar u fi frat waqt it-treddigħ, rispettivament.
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Maltese: Għal terapija addizzjonali fit-trattament ta' settiċemija puwerperali u tossemija (sindromu mastitemetrite-agalaktja) flimkien ma' terapija antibijotika xierqa.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Maltese: Kodiċi ATC veterinarja: QM01AC06.
English: Marketing authorisation holder and manufacturer responsible for batch release: Bimeda Animal Health Limited,
Maltese: Bimeda Animal Health Limited
English: Horses:
Maltese: Frat:
English: 20 μg/kg 65 μg/kg 65 μg/kg
Maltese: Equidae μg/kg μg/kg μg/kg
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
Maltese: Frat: laħam u ġewwieni tal-annimali: 15-il jum; ħalib: 5 ijiem Majjali: laħam u ġewwieni tal-annimali: 5 ijiem
English: MRLs Target tissues
Maltese: MRL Tessuti mmirati
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard Box: 10 ml, 50 ml or 100 ml vials
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-Kartun: Kunjetti ta' 10 ml, 50 ml jew 100 ml
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Maltese: Meloxicam għandu wkoll proprjetajiet anti-endotossiċi għax intwera li jinibixxi l-produzzjoni ta' thromboxane B2 ikkaġunata mill-għoti ta' E. coli endotoxin fl-għoġġiela, baqar waqt it-treddigħ u majjali.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Maltese: Wara l-għoti ta' doża waħda taħt il-ġilda ta' 0.5 mg ta' meloxicam/kg, intlaħqu valuri Cmax ta' 2.1 µg/ml u 2.7 µg/ml wara 7.7 sigħat u 4 sigħat fi frat żgħar u fi frat waqt it-treddigħ, rispettivament.
English: A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Maltese: Nefħa ħafifa li tgħaddi malajr fis-sit tal-injezzjoni wara l-għoti taħt il-ġilda, f'inqas minn 10% talbaqar li kienu ttrattati fi studji kliniċi.
English: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).
Maltese: Injezzjoni waħda ġol-vina b'doża ta' 0.6 mg ta' meloxicam / kg ta' piż tal-ġisem (jiġifieri 3.0 ml/ 100 kg ta' piż tal-ġisem).
English: Overdose (symptoms, emergency procedures, antidotes): In the case of overdose, symptomatic treatment should be initiated.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antodoti): F'każ ta' doża eċċessiva, għandu jinbeda trattament sintomatiku.
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No. 37/2010 indicates that no MRLs are required.
Maltese: L-addittivi elenkati f'sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 .
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Maltese: VETERINARJU Recocam 20 mg/ml soluzzjoni għall-injezzjoni għall-frat, majjali u żwiemel. meloxicam
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.
Maltese: Wara l-għoti ta' żewġ dożi fil-muskoli ta' 0.4 mg ta' meloxicam/kg, intlaħaq valur Cmax ta' 1.9 µg/ml wara siegħa fil-majjali.
English: For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, oral suspensions of meloxicam may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Maltese: Għall-użu sabiex tittaffa l-infjammazzjoni u għas-solliev tal-uġigħ f'mard muskoluskeletali li jkun kemm akut kif ukoll kroniku, jistgħu jintużaw suspensjonijiet orali ta' meloxicam għat-tkomplija tattrattament f'dożaġġ ta' 0.6 mg ta' meloxicam / kg ta' piż tal-ġisem, 24 siegħa wara l-għoti talinjezzjoni.
English: Active substance: Meloxicam20 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Meloxicam 20 mg/ml
English: Horses: meat and offal: 5 days
Maltese: Majjali: Laħam u ġewwieni tal-annimali: 5 ijiem
English: 6.5 Nature and composition of immediate packaging Pack size of 1 Type I clear glass vial with Teflon coated bromobutyl rubber stoppers and sealed with an aluminium flip-off tear-off seal.
Maltese: .6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar-rimi li huwa derivat minn dawn il-prodotti Kwalunkwe prodott mediċinali veterinarju li ma ġiex użat jew materjal għar-rimi li huwa derivat minn dan il-prodott mediċinali veterinarju għandhom jintremew skont kif jitolbu r-regolamenti tal-pajjiż.
English: PACKAGE SIZE
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Maltese: Injezzjoni waħda fil-muskolu b'doża ta' 0.4 mg ta' meloxicam / kg ta' piż tal-ġisem (jiġifieri 2.0 ml/100 / kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, kif ikun xieraq.
English: Horses: IV
Maltese: IV
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħda taħt il-ġilda jew ġol-vina, b'doża ta' 0.5 mg ta' meloxicam / kg ta' piż tal-ġisem (jiġifieri 2.5 ml / 100 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta' idratazzjoni mill-ġdid, skont kif ikun xieraq.
English: Pack size of 1 Type I clear glass vial with Teflon coated bromobutyl rubber stoppers and sealed with an aluminium flip-off tear-off seal.
Maltese: Għall-użu sabiex tittaffa l-infjammazzjoni u għas-solliev tal-uġigħ f'mard muskolu-skeletriku li jkun kemm akut kif ukoll kroniku.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses
Maltese: VETERINARJU Recocam 20 mg/ml soluzzjoni għall-injezzjoni għall-baqar, majjali u żwiemel.
English: The full EPAR for Bondenza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ ta' Bondenza jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Bondenza
Maltese: Informazzjoni oħra dwar Bondenza
English: Previously known as Ibandronic Acid Roche.
Maltese: Preċedentement magħruf bħala Ibandronic Acid Roche.
English: The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5-mg once-daily tablets.
Maltese: Iż-żewġ studji l-oħra qabblu kemm il-pilloli ta' 150 mg li jittieħdu darba fix-xahar (1,609 pazjenti) u kemm linjezzjonijiet (1,395 pazjent) mal-pilloli ta' 2.5 mg li jittieħdu kuljum.
English: The active substance in Bondenza, ibandronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Bondenza, l-aċidu ibandroniku, hija bisfosfonat.
English: ibandronic acid
Maltese: Bondenza aċidu ibandroniku
English: It is available as tablets (150 mg) and as a solution for injection in a prefilled syringe (3 mg).
Maltese: Jiġi f'pilloli (150 mg) u f'soluzzjoni għall-injezzjoni f'siringa diġà mimlija (3 mg).
English: This is a summary of the European public assessment report (EPAR) for Bondenza.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Bondenza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic Acid Roche on 23 February 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ibandronic Acid Roche fit-23 ta' Frar 2004.
English: In the first study, daily treatment with Bondenza 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
Maltese: Fl-ewwel studju, it-trattament li sar kuljum b'Bondenza f'għamla ta' pilloli ta' 2.5 mg naqqas ir-riskju ta' ksur ġdid fis-sinsla tad-dahar b'62% apparagun mal-plaċebo..
English: Bondenza is a medicine that contains the active substance ibandronic acid.
Maltese: Bondenza huwa mediċina li fiha s-sustanza attiva aċidu ibandroniku.
English: The most common side effects with Bondenza (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms.
Maltese: L-effetti sekondarji l-iżjed komuni bil-kura b'Bondenza (li dehru f'bejn pazjent 1 u 10 f'100) huma artralġja (uġiegħ fil-ġogi) u sintomi li jixbhu lil dawk tal-influwenza.
English: What is Bondenza?
Maltese: X'inhu Bondenza?
English: (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.)
Maltese: (F'żoni fejn ikun hemm ilma aħrax, jiġifieri fejn l-ilma tal-vit ikun fih hemm ħafna kaljċu maħlul, jista' jintuża ilma tal-flixkun b'kontenut minerali baxx.)
English: How has Bondenza been studied?
Maltese: Kif ġie studjat Bondenza?
English: Why has Bondenza been approved?
Maltese: Għaliex ġie approvat Bondenza?
English: The name of the medicine was changed to Bondenza on 18 August 2004.
Maltese: L-isem tal-mediċina nbidel u sar Bondenza fit-18 ta' Awwissu 2004.
English: Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets.
Maltese: Matul sentejn, id-densità tal-għadam fis-sinsla tad-dahar żdiedet b'7% bil-pilloli li jittieħdu kull xahar u b'6% bl-injezzjonijiet, apparagun ma' 5% bil-pilloli li jittieħdu kuljum.
English: Bondenza has been studied in three main studies involving women with osteoporosis.
Maltese: Bondenza ġie studjat fi tliet studji ewlenin fuq nisa bl-osteoporożi.
English: Bondenza is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Maltese: Bondenza jintuża fit-trattament tal-osteoporożi (marda li ġġib l-għadam fraġli) fin-nisa li jkunu għaddew mill-menopawża u li jkunu f'riskju li jiżviluppaw ksur fl-għadam.
English: What is the risk associated with Bondenza?
Maltese: X'inhu r-riskju assoċjat ma' Bondenza?
English: The first study compared Bondenza 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
Maltese: L-ewwel studju qabbel lil Bondenza f'għamla ta' pilloli ta' 2.5 mg b'pożoloġija ta' darba kuljum ma' plaċebo (trattament finta) fi kważi 3,000 mara, u eżamina kemm deher ksur ġdid fis-sinsla tad-dahar tal-pazjenti tul tliet snin.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Maltese: L-osteoporożi hija aktar komuni fin-nisa li jkunu għaddew mill-menopawża, meta jaqgħu l-livelli tal-ormon femminili estroġenu, peress li dan l-ormon jgħin l-għadam jibqa' f'saħħtu.
English: For the full list of all side effects reported with Bondenza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Bondenza, ara l-fuljett ta' tagħrif.
English: The CHMP decided that Bondenza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Bondenza huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Immediate Packaging Pack size pre-filled syringe (glass)
Maltese: Użu ġol-vitriju siringa mimlija għal-lest (ħġieġ) 1
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Isem (inventat) Qawwa Għamla farmaċewtika Mnejn jingħata Il-pakkett li jmiss malprodott
English: vial (glass)
Maltese: Użu ġol-vitriju kunjett (ħġieġ)
English: 90 sachets (with a dosing spoon)
Maltese: 90 qartas (b'kuċċarina għaddożaġġ)
English: 3 vials + 3 ampoules
Maltese: 3 kunjetti + 3 ampolli
English: 1 vial + 1 ampoule
Maltese: Kunjett 1 + ampolla 1
English: MA (EU) Number
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa
English: Medical Dictionary for Regulatory Activities (MedDRA) version 17.1.
Maltese: Medical Dictionary for Regulatory Activities (MedDRA) verżjoni 17.1.
English: 18 September 2019
Maltese: 18 ta' Settembru 2019
English: Cardiac dysfunction Grade 3
Maltese: Disfunzjoni kardijaka Grad 3
English: Adverse reaction Severity
Maltese: Reazzjoni avversa Severità
English: Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, or the BSEP.
Maltese: Lenvatinib mhuwiex substrat għal OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, jew il-BSEP.
English: Aspartate aminotransferase increased‡ Hypoalbuminaemia‡
Maltese: Żieda f'aspartate aminotransferase‡
English: Grade 3 (despite optimal antihypertensive therapy)
Maltese: Grad 3 (minkejja terapija ottimali kontra lpressjoni għolja)
English: Alanine aminotransferase increased‡
Maltese: Żieda f'alanine aminotransferase‡
English: Figure 2: Kaplan-Meier Plot of Overall Survival
Maltese: Figura 2: Kaplan-Meier Plot ta' Sopravivenza Globali
English: P Value lenvatinib + everolimus vs everolimus
Maltese: I)b lenvatinib + everolimus vs everolimus
English: Tumour assessments were evaluated according to RECIST 1.1.
Maltese: L-evalwazzjonijiet tat-tumuri ġew evalwati skont RECIST 1.1.
English: Resolves to less than 2 gm / 24 hours.
Maltese: Ifieq għal inqas minn 2 g/24 siegħa.
English: Resolves to Grade 0-1.
Maltese: Ifieq sa Grad 0-1.
English: Date of first authorisation: 25 August 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 25 ta' Awissu 2016
English: Tabulated list of adverse reactions for RCC and DTC studies Similar adverse reactions were observed in clinical trials in RCC and DTC.
Maltese: Lista tabulata ta' reazzjonijiet avversi għall-istudji dwar RCC u DTC Reazzjonijiet avversi simili ġew osservati fil-provi kliniċi f'RCC u DTC.
English: Figure 1: Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment)
Maltese: Figura 1: Kaplan-Meier Plot ta' Sopravivenza Mingħajr Progressjoni (Stima tal-Investigatur)
English: • The other ingredients are calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc.
Maltese: • Is-sustanzi mhux attivi l-oħra huma calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc.
English: • Very common (≥1/10)
Maltese: • Komuni ħafna (≥1/10)
English: Kisplyx 4 mg hard capsules EU/1/16/1128/001
Maltese: Kisplyx 4 mg kapsuli ibsin EU/1/16/1128/001
English: Haemorrhage includes: epistaxis, haemoptysis, haematuria, contusion, haematochezia, gingival bleeding, petechiae, pulmonary haemorrhage, rectal haemorrhage, blood urine present, haematoma, vaginal haemorrhage, conjunctival haemorrhage, haemorrhoidal haemorrhage, intracranial tumour haemorrhage, laryngeal haemorrhage, ecchymosis, increased tendency to bruise, post procedural haemorrhage, purpura, skin haemorrhage, aneurysm ruptured, arterial haemorrhage, eye haemorrhage, gastric haemorrhage, gastroduodenitis haemorrhagic, gastrointestinal haemorrhage, haematemesis, haemorrhage, haemorrhagic stroke, melaena, metrorrhagia, nail bed bleeding, haemothorax, postmenopausal haemorrhage, proctitis haemorrhagic, renal haematoma, splenic haemorrhage, splinter haemorrhages, subarachnoid haemorrhage, tracheal haemorrhage, tumour haemorrhage.
Maltese: Emorraġija tinkludi: epistassi, emoptisi, ematurja, kontużjoni, ematokeżija, ħruġ ta' demm millħanek, tikek żgħar vjola fuq il-ġilda, emorraġija pulmonari, emorraġija mir-rektum, demm preżenti fl-awrina, ematoma, emorraġija vaġinali, emorraġija konġuntivali, emorraġija talmurliti, emorraġija minn tumur intrakranjali, emorraġija larinġeali, ekkimożi, żieda fit-tendenza li titbenġel, emorraġija wara xi proċedura, purpura, emorraġija tal-ġilda, tiċrit ta' anewriżmu, emorraġija arterjali, emorraġija fl-għajn, emorraġija gastrika, gastroduwodenite emorraġika, emorraġija gastrointestinali, ematemesi, emorraġija, puplesija emorraġika, melaena, mestrwazzjoni esaġerata, ħruġ ta' demm mid-dwiefer, haemothorax, emorraġija wara lmenopawsa, proktite emorraġika, ematoma fil-kliewi, emorraġija fil-milsa, emorraġiji taħt iddwiefer, emorraġija subarakinojde, emorraġija trakeali, emorraġija minn tumur.
English: Kisplyx 10 mg hard capsules EU/1/16/1128/002
Maltese: Kisplyx 10 mg kapsuli ibsin EU/1/16/1128/002
English: Palmar-plantar erythrodysaesthesia syndrome Palmar erythema Rash Alopecia
Maltese: Sindrome ta' eritrodisestesija palmarplantar Eritema palmar Raxx Alopeċja
English: Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-polyamide/Aluminium /PVC/Aluminium li fihom 10 kapsuli.
English: Progression-free survival (PFS)a by Post-hoc Retrospective Independent Review
Maltese: Indipendenti Retrospettiva Post-hoc
English: • are over 75 years old
Maltese: • għandek aktar minn 75 sena
English: EU/1/16/1128/002 (Pack size of 30 hard capsules) EU/1/16/1128/005 (Pack size of 60 hard capsules) EU/1/16/1128/006 (Pack size of 90 hard capsules)
Maltese: EU/1/16/1128/002 (Daqs tal-pakkett ta' 30 kapsula iebsa) EU/1/16/1128/005 (Daqs tal-pakkett ta' 60 kapsula iebsa) EU/1/16/1128/006 (Daqs tal-pakkett ta' 90 kapsula iebsa)
English: In vitro, the lenvatinib blood-to-plasma concentration ratio ranged from 0.589 to 0.608 (0.1 - 10 μg/mL, mesylate).
Maltese: In vitro, il-proporzjon tal-konċentrazzjoni ta' lenvatinib fid-demm u fil-plażma varja minn 0.589 sa 0.608 (0.1 - 10 μg/mL, mesilate).
English: Hypocalcaemia‡ Hypercholesterolaemiab**
Maltese: Iperkolesterolemijab**
English: EU/1/16/1128/001 (Pack size of 30 hard capsules) EU/1/16/1128/003 (Pack size of 60 hard capsules) EU/1/16/1128/004 (Pack size of 90 hard capsules)
Maltese: EU/1/16/1128/001 (Daqs tal-pakkett ta' 30 kapsula iebsa) EU/1/16/1128/003 (Daqs tal-pakkett ta' 60 kapsula iebsa) EU/1/16/1128/004 (Daqs tal-pakkett ta' 90 kapsula iebsa)
English: Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS)
Maltese: Sindrome ta' enċefalopatija riversibbli posterjuri (PRES - Posterior reversible encephalopathy syndrome)/Sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS - Reversible posterior leucoencephalopathy syndrome)
English: Patients were stratified by haemoglobin level (≤13 g/dL vs. >13 g/dL for males and ≤11.5 g/dL vs >11.5 g/dL for females) and corrected serum calcium (≥10 mg/dL vs. <10 mg/dL).
Maltese: >13 g/dL għall-irġiel, u ≤11.5 g/dL vs >11.5 g/dL għan-nisa) u calcium fis-serum ikkoreġut (≥10 mg/dL vs.
English: Resolves to <480 ms or baseline
Maltese: Jirrisolvi għal <480 ms jew għal-linja bażi
English: CYP3A4 substrates
Maltese: Substrati ta' CYP3A
English: Anal fistula Flatulence Lipase increased Amylase increased
Maltese: Fistula anali Gass Żieda fil-lipase Żieda f'amylase
English: Microcrystalline cellulose Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Talc
Maltese: Low-substituted hydroxypropylcellulose
English: Table 5 Efficacy results in renal cell carcinoma lenvatinib 18 mg + everolimus 5 mg (N=51)
Maltese: Riżultati tal-effikaċja f'karċinoma taċ-ċelluli tal-kliewi lenvatinib 18 mg + everolimus 5 mg (N=51)
English: Name and address of the manufacturer responsible for batch release Eisai Manufacturing Ltd.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Eisai Manufacturing Ltd.
English: In the everolimus group, 6.0% of patients reported an arterial thromboembolism (4.0% were Grade ≥ 3).
Maltese: Fil-grupp ta' everolimus, 6.0% tal-pazjenti rrappurtaw tromboemboliżmu arterjali (4.0% kienu ta' Grad ≥ 3).
English: Patients with an ECOG (Eastern Cooperative Oncology Group) performance status of 2 or higher were excluded from the RCC study (see section 5.1).
Maltese: Pazjenti bi stat ta' prestazzjoni ECOG (Eastern Cooperative Oncology Group) ta' 2 jew ogħla, ġew esklużi mill-istudju dwar RCC (ara sezzjoni 5.1).
English: Based on the results of a post-hoc exploratory analysis in a limited number of patients per subgroup, the positive effect on PFS was seen regardless of which prior VEGF-targeted therapy was used: sunitinib (Hazard ratio [HR] = 0.356 [95% CI: 0.188, 0.674] or other therapies (HR = 0.350 [95% CI: 0.148, 0.828]).
Maltese: Ibbażat fuq ir-riżultati ta' analiżi esploratorja post-hoc f'numru limitat ta' pazjenti f'kull sottogrupp, ġie osservat effett pożittiv fuq PFS irrispettivament minn liema terapija mmirata VEGF intużat fil-passat: sunitinib (Proporzjon ta' periklu [HR] = 0.356 [95% CI: 0.188, 0.674] jew terapiji oħrajn (HR = 0.350 [95% CI: 0.148, 0.828]).
English: The capsules must be left in the liquid for at least 10 minutes and stirred for at least 3 minutes to dissolve the capsule shells.
Maltese: Il-kapsuli jridu jitħallew fil-likwidu għal mill-inqas 10 minuti u jitħawdu għal mill-inqas 3 minuti biex tħoll il-qxur tal-kapsuli.
English: The time to onset was 69.6 weeks.
Maltese: Iż-żmien sal-bidu kien ta' 69.6 ġimgħat.
English: Resolves to Grade 0-1 or baseline.
Maltese: Ifieq sa Grad 0-1 jew linja bażi.
English: Kisplyx is a medicine that contains the active substance lenvatinib.
Maltese: Kisplyx hu mediċina li fiha s-sustanza attiva lenvatinib.
English: Patients were required, among others, to have histological confirmation of predominant clear cell RCC, radiographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1), one prior VEGF-targeted therapy and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Maltese: Il-pazjenti kienu meħtieġa, fost l-oħrajn, li jkollhom konferma istoloġika ta' RCC predominanti taċ-ċelluli ċari, evidenza radjografika ta' progressjoni tal-marda skont ir-Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1), terapija waħda fil-passat b'VEGF immirat, u Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ta' 0 jew 1.
English: The median of average daily dose in the combination arm per subject was 13.5 mg of lenvatinib (75.0% of the intended dose of 18 mg) and 4.7 mg of everolimus (93.6% of the intended dose of 5 mg).
Maltese: 0% tad-doża intenzjonata ta' 18 mg) u 4.7 mg ta' everolimus (93.6% taddoża intenzjonata ta' 5 mg).