FrancophonIA/ELRC3.0 huggingface dataset:
English: For this indication and population, it is considered particularly important that oral formulations are available.
Maltese: Għal din l-indikazzjoni u popolazzjoni, huwa meqjus partikularment importanti li jkun hemm formulazzjonijiet orali disponibbli.
English: o Is favourable in adults for ‘symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting' (parenteral route) and ‘symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting.
Maltese: o Huwa favorevoli fl-adulti għall-‘kura sintomatika ta' dardir u rimettar, inkluż dardir u rimettar akuti minħabba emigranja' (rotta parenterali) u l-‘kura sintomatika ta' dardir u rimettar, inkluż dardir u rimettar akuti minħabba emigranja. Metoclopramide jista' jintuża f'kombinazzjoni ma' analġesiċi orali biex itejjeb l-assorbiment tal-analġesiċi f'emigranja akuta' (rotta orali)
English: • The Committee considered that the risk of serious neurological adverse events can be minimised by using lower doses of metoclopramide and limiting treatment duration.
Maltese: • Il-Kumitat ikkunsidra li r-riskju ta' avvenimenti avversi serji newroloġiċi jista' jiġi minimizzat blużu ta' dożi aktar baxxi ta' metoclopramide u t-tul tal-kura jiġi limitat.
English: The data presented in support of the effect of metoclopramide in post-operative nausea and vomiting indicates that it has similar efficacy to other active substances authorised in this indication.
Maltese: Id-dejta ppreżentata b'appoġġ tal-effett ta' metoclopramide f'dardir u rimettar wara operazzjoni tindika li għandu effikaċja simili għal sustanzi attivi oħra awtorizzati f'din indikazzjoni.
English: Therefore, in order to minimise the risk of serious neurological adverse reactions such as acute extrapyramidal symptoms and irreversible tardive dyskinesia, the dose should be restricted to the minimum effective dose, which for adults is considered to be 10 mg three times daily.
Maltese: Għalhekk, sabiex jiġi minimizzat irriskju ta' reazzjonijiet avversi serji newroloġiċi bħal sintomi ekstrapiramidali akuti u diskinesija tardiva irriversibbli, id-doża għandha tiġi ristretta għall-anqas doża effettiva, li għall-adulti hija meqjusa li hija ta' 10 mg tliet darbiet kuljum.
English: For severe hepatic impairment, the existing recommendation for 50% dose reduction is appropriate.
Maltese: Għal indeboliment epatiku sever, irrakkomandazzjoni eżistenti għal tnaqqis ta' 50% fid-doża hija adattata.
English: Risk Minimisation Measures
Maltese: Miżuri għall-Minimizzazzjoni tar-Riskji
English: While considering that the concentration 4 mg/ml is appropriate for adults, the MAH recognised that it is too high for children and therefore proposed the measures to avoid the risk of overdose in children, including contraindication in this patient population.
Maltese: Filwaqt li kkunsidra li l-konċentrazzjoni ta' 4 mg/ml hija adegwata għall-adulti, il-MAH irrikonoxxa li hija għolja wisq għat-tfal u għalhekk ippropona l-miżuri biex jiġi evitat ir-riskju ta' doża eċċessiva fit-tfal, inkluż kontraindikazzjoni f'din il-popolazzjoni ta' pazjenti.
English: According to the BNFc, in patients at low risk of emesis, pre-treatment with metoclopramide continued for up to 24 hours after chemotherapy is often effective.
Maltese: Skont ilBNFc, f'pazjenti b'riskju baxx ta' emesi, kura minn qabel b'metoclopramide li tibqa' għaddejja sa 24 siegħa wara l-kimoterapija ħafna drabi hija effettiva.
English: The exception is the treatment of established post-operative nausea and vomiting, which had already been recommended to be maintained in a previous worksharing procedure under Article 45 of Regulation (EC) No 1901/2006.
Maltese: L-eċċezzjoni hija l-kura ta' dardir u rimettar stabbiliti wara operazzjoni, li diġà kienet ġiet rakkomandata biex tinżamm fi proċedura preċedenti tal-qsim taxxogħol skont l-Artikolu 45 tar-Regolament (KE) Nru 1901/2006.
English: In the absence of an established benefit, and taking into account the safety profile of metoclopramide, the Committee considered that the benefit-risk balance of metoclopramide in this indication is negative.
Maltese: Fin-nuqqas ta' benefiċċju stabbilit, u b'kunsiderazzjoni tal-profil tassigurtà ta' metoclopramide, il-Kumitat ikkunsidra li l-bilanċ tal-benefiċċju-riskju ta' metoclopramide f'din l-indikazzjoni huwa negattiv.
English: Established renal failure is defined as ClCr < 15 ml/min, therefore this cut-off should be included in any dosing recommendations.
Maltese: L-insuffiċjenza renali stabbilita hija definita bħala ClCr < 15 ml/min, għalhekk dan il-limitu għandu jiġi nkluż f'kull rakkomandazzjoni ta' dożaġġ.
English: The majority of the efficacy data submitted during the current procedure had already been assessed during the previous paediatric worksharing procedure under Article 45 of Regulation (EC) No 1901/2006, and the new data did not add relevant new elements to the previous assessment.
Maltese: Il-maġġoranza tad-dejta dwar l-effikaċja ppreżentata matul il-proċedura attwali diġà kienet ġiet ivvalutata matul il-proċedura preċedenti tal-qsim tax-xogħol pedjatriku skont l-Artikolu 45 tarRegolament (KE) Nru 1901/2006, u d-dejta l-ġdida ma żiedet l-ebda elementi ġodda rilevanti malvalutazzjoni preċedenti.
English: Therefore the Committee considered that it is an important risk minimisation measure to restrict the maximum concentration of oral liquid formulations to 1 mg/ml, to ensure that clear instructions are given in the product information on posology for paediatric patients and that these oral liquid formulations are supplied with an appropriate measuring device such as a graduated oral syringe.
Maltese: Għalhekk il-Kumitat ikkunsidra li r-restrizzjoni talkonċentrazzjoni massima ta' formulazzjonijiet likwidi li jingħataw mill-ħalq għal 1 mg/ml, li jiġi żgurat li fl-informazzjoni dwar il-prodott jingħataw istruzzjonijiet ċari dwar il-pożoloġija għal pazjenti pedjatriċi u li dawn il-formulazzjonijiet likwidi li jingħataw mill-ħalq jiġu fornuti b'apparat adegwat għall-kejl bħal siringa gradwata għall-użu orali huma miżuri importanti għall-minimizzazzjoni tar-riskji.
English: Limited data exists on the onset of action of oral liquid formulations in comparison with tablets.
Maltese: Teżisti dejta limitata dwar il-bidu ta' azzjoni ta' formulazzjonijiet likwidi li jingħataw mill-ħalq meta mqabbla ma' pilloli.
English: 31 January 2020
Maltese: 31 Jannar 2020
English: The drip lasts about 60 minutes.
Maltese: Dan id-dripp idum għaddej madwar 60 minuta.
English: Infusion-related reactions (IRRs)
Maltese: Reazzjonijiet marbuta mal-infużjoni (IRRs)
English: Manufacturer Lilly S.A.
Maltese: Manifattur Lilly S.A.
English: EU/1/16/1143/003 - 2 vials of 19 mL.
Maltese: EU/1/16/1143/003 - 2 kunjetti ta' 19 ml.
English: Lartruvo contains sodium
Maltese: Lartruvo fih sodium
English: Doxorubicin alone (n = 67)
Maltese: (n = 67)
English: Frequency overall Grade 3/4 frequency
Maltese: Il-frekwenza ta' Grad 3/4
English: PFS according to a post-hoc, blinded, independent assessment was 8.2 months vs 4.4 months; HR = 0.670; p = 0.1208.
Maltese: Il-PFS, skont evalwazzjoni indipendenti, post-hoc u fejn l-investigaturi u l-individwi kienu fl-għama, kien ta' 8.2 xhur kontra 4.4 xhur, HR = 0.670; p = 0.1208.
English: Store in a refrigerator (2° C - 8° C).
Maltese: Aħżen fi friġġ (2 °C - 8 °C).
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2° C - 8° C).
English: The final total volume in the container should be 250 mL.
Maltese: Il-volum finali fil-kontenitur għandu jkun 250 mL.
English: Subgroups analysis of OS is shown in figure 2.
Maltese: L-analiżi ta' OS fis-sottogruppi hija murija fil-figura 2.
English: Pack of 1 vial of 50 mL.
Maltese: Pakkett ta' kunjett 1 ta' 50 mL.
English: Kaplan-Meier curves of overall survival for Lartruvo plus doxorubicin versus doxorubicin alone
Maltese: Kaplan-Meier ta' sopravivenza totali għal Lartruvo flimkien ma' doxorubicin versus doxorubicin waħdu
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 November 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 9 Novembru 2016
English: Three Grade ≥3 events, including one fatal, have been reported across the clinical development programme of olaratumab (see section 4.4).
Maltese: Tliet avvenimenti ta' Grad ≥3, inkluż wieħed fatali, ġew irrapportati mill-programm kollu ta' żvilupp kliniku ta' olaratumab (ara sezzjoni 4.4).
English: Rare (≥ 1/10,000 to < 1/1,000)
Maltese: Rari (≥ 1/10,000 sa < 1/1,000)
English: Name and address of the manufacturer(s) of the biological active substance(s) ImClone Systems LLC
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva/i ImClone Systems LLC
English: Forest plot for subgroup analysis of overall survival (ITT population)
Maltese: Forest plot għal analiżi ta' sottogrupp ta' sopravivenza totali (popolazzjoni ITT)
English: Date of latest renewal: 21 September 2017
Maltese: Data tal-aħħar tiġdid: 21 Settembru 2017 10.
English: Olaratumab is a human monoclonal antibody.
Maltese: Olaratumab huwa antikorp monoklonali uman.
English: Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Maltese: Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht L-Olanda
English: Sodium restricted diet
Maltese: Dieta ristretta mis-sodium
English: Excipients: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 and water for injections.
Maltese: Eċċipjenti: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 u ilma għall-injezzjonijiet.
English: Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (calculated creatinine clearance [CLcr] 60-89 mL/min, n = 43), or moderate (CLcr 30-59 mL/min, n = 15) renal impairment compared to patients with normal renal function (CLcr ≥90 mL/min, n = 85).
Maltese: Abbażi ta' analiżi PopPK, ma kienu osservati l-ebda differenzi ta' sinifikat kliniku fit tneħħija ta' olaratumab f'pazjenti b'indeboliment ħafif (tneħħija tal-kreatinina kkalkulata - calculated creatinine clearance [CLcr] 60-89 mL/min, n = 43), jew moderat (CLcr 30-59 mL/min, n = 15) talkliewi meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi (CLcr ≥90 mL/min, n = 85).
English: • Fever
Maltese: - Fsada
English: Doxorubicin can cause cardiotoxicity.
Maltese: Tossiċità kardijaka Doxorubicin jista' jikkawżaw kardjotossiċità.
English: It is available in packs of: - 1 vial of 19 mL - 2 vials of 19 mL - 1 vial of 50 mL
Maltese: Huwa disponibbli f'pakketti ta': - kunjett 1 ta' 19 mL - 2 kunjetti ta' 19 mL - kunjett 1 ta' 50 mL
English: What Lartruvo contains - The active substance is olaratumab.
Maltese: X'fih Lartruvo - Is-sustanza attiva hi olaratumab.
English: Pack of 2 vials of 19 mL.
Maltese: Pakkett ta' 2 kunjetti ta' 19 mL.
English: Summary of survival data - ITT population Lartruvo plus doxorubicin (n = 66)
Maltese: Lartruvo flimkien ma' doxorubicin (n = 66)
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC27
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: Pack of 1 vial of 19 mL.
Maltese: Pakkett ta' kunjett 1 ta' 19 mL.
English: Randomisation was stratified by PDGFR-α expression (positive versus negative), number of previous lines of treatment (0 versus 1 or more lines), histological tumour type (leiomyosarcoma, synovial sarcoma, and others) and ECOG performance status (0 or 1 versus 2).
Maltese: L-għażla arbitrarja kienet stratifikata permezz tal-espressjoni ta' PDGFR-α (pożittiva versus negattiva), in-numru ta' linji ta' trattament preċedenti (0 versus linja 1jew aktar), tip istoloġiku tat-tumur (lejomijosarkoma, sarkoma sinovjali, u oħrajn) u l-istat ta' eżekuzzjoni ta' ECOG (0 jew 1 versus 2).
English: No data were available from patients with severe renal impairment (CLcr 15-29 mL/min).
Maltese: Ma hija disponibbli l-ebda dejta minn pazjenti b'indeboliment qawwi tal-kliewi (CLcr 15-29 mL/min).
English: Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity.
Maltese: Immunoġeniċità Bħal kull proteina terapewtika oħra, hemm il-possibbiltà għall-immunoġeniċità.
English: Administer via an infusion pump.
Maltese: Mhux applikabbli.
English: Tabulated list of adverse reactions
Maltese: Lista ta' reazzjnijiet avversi miġbura f'tabella
English: Patients were randomised in a 1:1 ratio to either olaratumab (15 mg/kg) on Day 1 and Day 8 plus doxorubicin (75 mg/m²) on Day 1 of each 21-day cycle for up to 8 cycles or doxorubicin (75 mg/m2) alone on Day 1 of each 21-day cycle, also for up to 8 cycles.
Maltese: f'Jum 1 u Jum 8 flimkien ma' doxorubicin (75 mg/m²) f'Jum 1 ta' kull ċiklu ta' 21 jum għal mhux aktar minn 8 ċikli jew doxorubicin (75 mg/m2) waħdu f'Jum 1 ta' kull ċiklu ta' 21 jum għal mhux aktar minn 8 ċikli ukoll.
English: Premedication with an H1 antagonist (e.g., diphenhydramine) and dexamethasone (or equivalent medicinal products) should be given, intravenously, 30-60 minutes prior to the olaratumab doses on days 1 and 8 of cycle 1 in all patients.
Maltese: Premedikazzjoni b'antagonist tar-riċettur H1 (eż., diphenhydramine) u dexamethasone (jew prodotti mediċinali ekwivalenti) għandha tingħata, mill-vini, 30-60 minuta qabel id-dożi ta' olaratumab filjiem 1 u 8 taċ-ċiklu 1 fil-pazjenti kollha.
English: Key secondary efficacy outcome measures were overall survival (OS) and objective response rate (ORR) (see Table 3).
Maltese: Il-kejl tar-riżultati l-aktar importanti ta' effikaċja sekondarja kienu sopravivenza totali (OS - Overall Survival) u rata oġġettiva ta' rispons (ORR - objective response rate) (ara Tabella 3).
English: Each 50 mL vial contains approximately 57 mg (2.5 mmol) sodium.
Maltese: Kull kunjett ta' 50 mL fih madwar 57 mg (2.5 mmol) sodium.
English: More than 25 different soft tissue sarcoma subtypes were represented in this trial, the most frequent being leiomyosarcoma (38.4 %), undifferentiated pleomorphic sarcoma (18.1 %) and liposarcoma (17.3 %).
Maltese: Aktar minn 25 sottotip differenti ta' sarkoma fit-tessut artab kienu rrapreżentati f'dan l-istudju, li l-aktar frekwenti minnhom kienu lejomijosarkoma (38.4 %), sarkoma pleomorfika mhux differenzjata (18.1 %) u liposarkoma (17.3 %).
English: Lartruvo has been administered in a Phase 1 study up to 20 mg/kg on days 1 and 8 of a 21 day cycle without reaching a maximum tolerated dose.
Maltese: Lartruvo ngħata fi studju ta' Fażi 1 sa 20 mg/kg fil-jiem 1 u 8 minn ċiklu ta' 21 jum mingħajr ma laħaq doża massima ttollerata.
English: In the olaratumab plus doxorubicin arm, the most serious (Grade ≥3) adverse drug reactions (ADRs) observed were neutropenia (54.7 %) and musculoskeletal pain (7.8 %).
Maltese: Fil-fergħa ta' olaratumab flimkien ma' doxorubicin, l-aktar reazzjonijiet avversi serji (Grad ≥3) għallmediċina (ADRs) li ġew osservati kienu newtropenija (54.7 %) u uġigħ muskoluskeletriku (7.8 %).
English: Infusion reactions Lartruvo has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Maltese: Lartruvo ġie assoċjat ma' reazzjonijiet għall-infużjoni (ara sezzjoni 2 “Twissijiet u prekawzjonijiet”).
English: The median cumulative dose of doxorubicin was 487.6 mg/m2 in the olaratumab plus doxorubicin arm and 299.6 mg/m2 in the doxorubicin alone arm.
Maltese: Il-medjan tad-doża kumulattiva ta' doxorubicin kienet 487.6 mg/m2 fil-fergħa ta' olaratumab flimkien ma' doxorubicin u 299.6 mg/m2 fil-fergħa ta' doxorubicin waħdu.
English: Infusion-related reactions (IRRs), including anaphylactic reactions, were reported in clinical trials with olaratumab.
Maltese: Reazzjonijiet marbuta mal-infużjoni (IRRs), inkluż reazzjonijiet anafilattiċi, kienu rrappurtati fi provi kliniċi b'olaratumab.
English: Very Common Very Common Very Common Common
Maltese: Komuni Ħafna Komuni Komuni Ħafna Komuni
English: Each 19mL vial contains approximately 22 mg (1 mmol) sodium.
Maltese: Kull kunjett ta' 19 mL fih madwar 22 mg (1 mmol) sodium.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/001-003
Maltese: EU/1/16/1143/001-003
English: The most frequent ADRs associated with permanent treatment discontinuation occurred in 3 (4.7 %) patients of which the most frequent were infusion-related reactions (3.1 %) and mucositis (1.6 %).
Maltese: L-aktar ADRs frekwenti assoċjati ma' twaqqif permanenti tat-trattament seħħew fi 3 (4.7 %) pazjenti li minnhom l-aktar frekwenti kienu reazzjonijiet marbuta mal-infużjoni (3.1 %) u mukosite (1.6 %).
English: There was a higher incidence of Grade ≥3 adverse reactions, adverse reactions leading to discontinuation and a higher rate of haematological toxicity in the elderly population compared to the overall study population (see section 4.2).
Maltese: Tossiċità fl-anzjani Kien hemm inċidenza akbar ta' reazzjonijiet avversi ta' Grad ≥3 li wasslu għat-twaqqif tal-mediċina u rata ogħla ta' tossiċità ematoloġika fil-popolazzjoni anzjana meta mqabbla mal-popolazzjoni totali taħt studju (ara sezzjoni 4.2).
English: Vials contain 190 mg or 500 mg as a 10 mg/mL solution of olaratumab.
Maltese: Il-kunjetti fihom 190 mg jew 500 mg bħala soluzzjoni ta' 10 mg/mL ta' olaratumab.
English: In case of recurrence of a Grade 4 toxicity, treatment with olaratumab should be permanently discontinued.
Maltese: F'każ li terġa' sseħħ tossiċità ta' Grad 4, it-trattament b' olaratumab għandu jitwaqqaf b'mod permanenti.
English: Name and address of the manufacturer(s) responsible for batch release Lilly S.A.
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Lilly S.A.
English: One vial of 19 mL contains 190 mg olaratumab.
Maltese: Kunjett wieħed ta' 19 mL fih 190 mg olaratumab.
English: The population pharmacokinetic (PopPK) model-based mean (CV %) volume of distribution of olaratumab at steady state (Vss) was 7.7 L (16 %).
Maltese: Abbażi tal-mudell farmakokinetiku ta' popolazzjoni (PopPK - population pharmacokinetic) il-medja tal-volum (CV %) ta' distribuzzjoni ta' olaratumab fl-istat fiss (Vss - steady state) kienet ta' 7.7 L
English: Difference in objective response rate [complete response (CR) + partial response (PR)] according to investigator assessment was not statistically significant (18.2 % vs 11.9 % in patients randomised to olaratumab plus doxorubicin compared to patients randomized to doxorubicin respectively).
Maltese: Id-differenza firrata ta' rispons oġġettiv [rispons sħiħ (CR - complete response) + rispons parzjali (PR - partial response)] skont l-evalwazzjoni tal-investigatur ma kinitx statistikament sinifikanti (18.2 % vs 11.9 %
English: Patients receiving olaratumab and doxorubicin are at risk of haemorrhagic events (see section 4.8).
Maltese: Avvenimenti emorraġiċi Pazjenti li jirċievu olaratumab u doxorubicin huma f'riskju li jkollhom avvenimenti emorraġiċi (ara sezzjoni 4.8).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One mL of concentrate contains 10 mg of olaratumab.
Maltese: ATTIVA(I) mL wieħed ta' konċentrat fih 10 mg ta' olaratumab.
English: Patients with gastrointestinal stromal tumours (GIST) or Kaposi sarcoma were not enrolled.
Maltese: Pazjenti b'tumuri gastrointestinali tal-istroma (GIST - gastrointestinal stromal tumours) jew sarkoma Kaposi ma ġewx irreġistati fl-istudju.
English: Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (total bilirubin within upper limit of normal [ULN] and AST>ULN, or total bilirubin > 1.0-1.5 times ULN and any AST level, n = 16), or moderate (total bilirubin > 1.5-3.0 times ULN, n = 1) hepatic impairment compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN, n = 126).
Maltese: [ULN] u AST>ULN jew bilirubin totali > 1.0-1.5 drabi aktar mill-ULN u kwalunkwe livell ta' AST, n = 16), jew moderat (bilirubin totali > 1.5-3.0 darbiet aktar mill- ULN, n = 1) tal-fwied meta mqabbla ma' pazjenti b'funzjoni normali tal-fwied (bilirubin totali u AST ≤ ULN, n = 126).
English: How to store Lartruvo
Maltese: Mediċini oħra u Lartruvo
English: Please refer to the doxorubicin SmPC for complete descriptions of all adverse events associated with doxorubicin treatment
Maltese: Jekk jogħġbok irreferi għall-SmPC ta' doxorubicin għad-deskrizzjonijiet kompleti ta' kull avveniment avvers assoċjat mat-trattament b'doxorubicin.
English: Possible side effects
Maltese: Effetti sekondarji possibbli 5.
English: In case of overdose, use supportive therapy.
Maltese: F'każ ta' doża eċċessiva, uża terapija ta' sostenn.
English: No other formal DDI studies with olaratumab and medicinal products commonly used in cancer patients, including those with STS (e.g. antiemetics, analgesics, anti-diarrheal drugs, oral contraceptives, etc.), have been performed.
Maltese: Ma saru l-ebda studji formali DDI oħra b'olaratumab u prodotti mediċinali li ssoltu jintużaw f'pazjenti bil-kanċer, inkluż dawk b'STS (eż. Antiemitiċi, analġesiċi, mediċini kontra d-dijarea, kontraċettivi orali, eċċ.).
English: The median age was 58 years with 42 patients ≥ 65 years of age.
Maltese: Il-medjan tal-età kien ta' 58 sena bi 42 pazjent li kellhom età ≥ 65 sena. 86.4 % tal-pazjenti kienu Kawkasiċi.
English: After dilution in sodium chloride 9 mg/mL (0.9 %) solution for injection, olaratumab is administered as an intravenous infusion over approximately 60 minutes.
Maltese: Wara d-dilwizzjoni f'soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9 %), olaratumab jingħata bħala infużjoni fil-vini fuq perjodu ta' madwar 60 minuta.
English: Administration of an anti-murine PDGFR- α surrogate antibody to pregnant mice during organogenesis at 50 and 150 mg/kg resulted in increased malformations (abnormal eyelid development) and skeletal alterations (frontal/parietal additional ossification site).
Maltese: L-għoti ta' antikorp sostitut kontra PDGFR- α ta' annimali gerriema lill-ġrieden tqal waqt organoġenesi b'50 u 150 mg/kg wassal għal żidiet fil-formazzjonijiet ħżiena (żvilupp mhux normali ta' tebqet l-għajn) u tibdil fl-iskeletru (sit ta' ossifikazzjoni addizzjonali frontali/parjetali).
English: The safety and efficacy of olaratumab in children aged 0 to 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' olaratumab fit-tfal minn età ta' 0 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: One vial of 50 mL contains 500 mg olaratumab.
Maltese: Kunjett wieħed ta' 50 mL fih 500 mg olaratumab.
English: This corresponds to a mean terminal half-life of approximately 11 days.
Maltese: Dan jaqbel ma' medja ta' half-life terminali ta' madwar 11-il jum.
English: Patients receiving olaratumab and doxorubicin are at risk of neutropenia (see section 4.8).
Maltese: Pazjenti li jirċievu olaratumab u doxorubicin huma f'riskju li jkollhom newtropenija (ara sezzjoni 4.8).
English: Premedication
Maltese: Assorbiment
English: Efficacy results are shown in Table 3 and Figures 1 and 2.
Maltese: Ir-riżultati ta' effikaċja qed jintwerew f'Tabella 3 u Figuri 1 u 2.
English: System organ class
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Olaratumab recognises and attaches specifically to a protein known as platelet-derived growth factor receptor-α (PDGFR-α).
Maltese: tkabbir derivat mill-plejtlets (PDGFR-α platelet derived growth factor receptor-α).
English: There are no data for the combination of olaratumab and doxorubicin in anthracycline pre-treated patients, including pre-treatment with doxorubicin (see section 4.1).
Maltese: Ma hemm l-ebda dejta dwar olaratumab flimkien ma' doxorubicin f'pazjenti ttrattati b'anthracycline qabel inkluż trattament qabel b'doxorubicin (ara sezzjoni 4.1).
English: Posology adjustments for olaratumab
Maltese: Aġġustamenti fil-pożoloġija għal olaratumab
English: Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Maltese: Lartruvo 10 mg/mL konċentrat għal soluzzjoni għall-infużjoni olaratumab