FrancophonIA/ELRC3.0 huggingface dataset:
English: For all subsequent infusions, premedication with the following (or equivalent medicinal products) diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone, should be given.
Maltese: Għall-infużjonijiet sussegwenti kollha, għandha tingħata premedikazzjoni b'dawn li ġejjin (jew prodotti mediċinali ekwivalenti): diphenhydramine hydrochloride (minn ġol-vini), paracetamol, u dexamethasone.
English: There are no data regarding olaratumab administration in patients with severe renal impairment (calculated creatinine clearance < 30 mL/min) (see section 5.2).
Maltese: M'hemm l-ebda dejta dwar l-għoti ta' olaratumab f'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina kkalkulata < 30 mL/min) (ara sezzjoni 5.2).
English: Lartruvo contains the active substance olaratumab, which belongs to a group of medicines called monoclonal antibodies.
Maltese: Lartruvo fih is-sustanza attiva olaratumab, li tagħmel parti minn grupp ta' mediċini msejħa antikorpi monoklonali.
English: This medicine contains 22 mg sodium in each 19 mL vial and 57 mg sodium in each 50 mL vial.
Maltese: Din il-mediċina fiha 22 mg sodium f'kull kunjett ta' 19 mL u 57 mg sodium f'kull kunjett ta' 50 mL.
English: To administer using pre-filled intravenous infusion containers Based on the calculated volume of olaratumab, aseptically remove the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection from the prefilled 250 mL intravenous container and transfer the olaratumab medicine into the container to bring the final volume in the container back to 250 mL.
Maltese: Abbażi tal-volum ikkalkulat ta' olaratumab, b'mod asettiku neħħi l-volum korripsondenti tassoluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9 %) mill-kontenitur ta' 250 mL mimli għal-lest għal għoti mill-vini u ttrasferixxi l-mediċina olaratumab għal ġol-kontenitur biex iġġib ilvolum finali fil-kontenitur lura għal 250 mL.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/001
Maltese: EU/1/16/1143/001
English: In a dedicated DDI study, no pharmacokinetic interactions were observed in patients between olaratumab and doxorubicin.
Maltese: F'studju ddedikat DDI, fil-pazjenti, ma ġew osservati ebda interazzjonijiet farmakokinetiċi bejn olaratumab u doxorubicin.
English: In the phase 2 trial, the incidence of neutropenia was 59.4 % (all Grades) and 54.7 % (Grade 3) in the olaratumab plus doxorubicin arm and 38.5 % (all Grades) and 33.8 % (Grade 3) in the doxorubicin alone arm.
Maltese: fil-fergħa ta' olaratumab flimkien ma' doxorubicin u 38.5 % (il-Gradi kollha) u 33.8 % (Grad 3) filfergħa ta' doxorubicin waħdu.
English: Haemorrhagic events
Maltese: Reazzjoni Avversaa
English: Olaratumab is an antagonist of platelet derived growth factor receptor-α (PDGFR-α), expressed on tumour and stromal cells.
Maltese: Olaratumab huwa antagonist tar-riċettur-α ta' fattur ta' tkabbir derivat mill-plejtlets (PDGFR-αplatelet derived growth factor receptor-α), espress fuq iċ-ċelluli tat-tumur u tal-istroma.
English: The rate of treatment-emergent cardiac dysfunction was comparable between the two treatment arms (7.8 % in the Investigational Arm and 6.2 % in the Control Arm).
Maltese: Ir-rata ta' funzjoni kardijaka ħażina li feġġet minħabba t-trattament kienet kumparabbli bejn iż-żewġ fergħat ta' trattament (7.8 % fil-Fergħa ta' Investigazzjoni u 6.2 % fil-Fergħa ta' Kontroll).
English: 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Maltese: Soluzzjoni ta' 50 mL f'kunjett (ħġieġ tat-Tip I) b'tapp elastomeriku tal-chlorobutyl, siġill tal-aluminju u għatu tal-polypropylene.
English: 19 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Maltese: Soluzzjoni ta' 19 mL f'kunjett (ħġieġ tat-Tip I) b'tapp elastomeriku tal-chlorobutyl, siġill tal-aluminju u għatu tal-polypropylene.
English: In the phase 2 trial, patients in both treatment groups that received 5 or more cycles of doxorubicin received dexrazoxane prior to each dose of doxorubicin from cycle 5 onwards to minimize the risk of doxorubicin-related cardiotoxicity (see sections 4.8 and 5.1).
Maltese: Fi prova ta' fażi 2, il-pazjenti fiż-żewġ gruppi ta' trattament li rċivew 5 ċikli jew aktar ta' doxorubicin rċivew dexrazoxane qabel kull doża ta' doxorubicin minn ċiklu 5 'l quddiem biex jitnaqqas ir-riskju ta' kardjotossiċità marbuta ma' doxorubicin (ara sezzjonijiet 4.8 u 5.1).
English: Your doctor will give you other medicines before you receive Lartruvo to reduce the risk of infusionrelated reactions.
Maltese: It-tabib tiegħek se jagħtik mediċini oħra qabel ma inti tirċievi Lartruvo biex jitnaqqas ir-riskju ta' reazzjonijiet marbuta mal-infużjoni.
English: Very rare (< 1/10,000)
Maltese: Rari ħafna (< 1/10,000)
English: IRRs were reported in 12.5 % of patients and mainly present as chills, fever or dyspnoea.
Maltese: IRRs ġew irrappurtati fi 12.5 % tal-pazjenti u jidhru l-aktar bħala tkexkix ta' bard, deni jew qtugħ ta'
English: Progression free survival, months* Median (95 % CI) Hazard ratio (95 % CI) p-value Overall survival, months Median (95 % CI) Hazard ratio (95 % CI) p-value Abbreviations: CI = confidence interval * By investigator assessment **Met phase 2 protocol defined significance level of 0.19
Maltese: Taqsir il-kliem: CI (confidence interval) = intervall ta' kunfidenza * Skont il-valutazzjoni tal-investigatur **Issodisfaw il-livell ta' sinifkanza ta' 0.19 iddefinita mill-protokoll ta' fażi
English: The foetal effects in mice administered the surrogate antibody occurred at exposures less than the AUC exposure at the maximum recommended human dose of 15 mg/kg olaratumab.
Maltese: L-effetti fuq il-fetu fil-ġrieden li ngħataw l-antikorp sostitut seħħew f'esponimenti anqas mill-esponiment tal-AUC bid-doża massima rrakkomandata fil-bnedmin ta' 15-il mg/kg olaratumab.
English: ADRs which were reported in patients with soft tissue sarcoma treated with olaratumab in combination with doxorubicin in the Phase 2 study are listed below in Table 2 in MedDRA body system organ class, frequency and grade of severity.
Maltese: ADRs li kienu rrappurtati f'pazjenti b'sarkoma fit-tessut artab ittrattati b'olaratumab flimkien ma' doxorubicin fl-istudju ta' Fażi 2 huma elenkati taħt fit-tabella 2 skont il-klassi tas-sistemi u tal-organi tal-ġisem ta' MedDRA, il-frekwenza u l-grad ta' severità.
English: Reproductive and development toxicity study conducted with an anti-murine PDGFRα antibody in mice showed foetal malformations and skeletal alterations (see section 5.3).
Maltese: Studju dwar effett tossiku fuq is-sistema riproduttiva u l-iżvilupp li sar fil-ġrieden b'antikorp kontra PDGFRα ta' annimali gerriema wera malformazzjonijiet fetali u tibdil skeletali (ara sezzjoni 5.3).
English: Patients had received 0-4 previous lines of therapy for treatment of advanced disease but had not previously received treatment with anthracyclines.
Maltese: Il-pazjenti kienu rċivew minn linji 0-4 ta' terapija preċedenti għattrattament ta' mard avvanzat iżda ma kinux irċivew trattament preċedenti b'anthracyclines.
English: Description of selected ADRs
Maltese: Deskrizzjoni ta' ADRs magħżula
English: • Flushing
Maltese: - nawsja
English: As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of olaratumab.
Maltese: Peress li l-antikorpi monoklonali mhumiex immetabolizzati mill-enzimi tat-tip ċitokromu P450 (CYP) jew enzimi oħra li jimmetabolizzaw il-mediċini, l-inibizzjoni jew l-istimulazzjoni ta' dawn l-enzimi minn prodotti mediċinali li jingħataw fl-istess ħin mhuwiex maħsub li jaffettwa il-farmakokinetika ta' olaratumab.
English: Vials contain 190 mg or 500 mg as a 10 mg/mL solution of olaratumab; calculate the dose and volume of olaratumab needed to prepare the infusion solution.
Maltese: Il-kunjetti fihom 190 mg jew 500 mg bħala soluzzjoni ta' 10 mg/mL ta' olaratumab; ikkalkula d-doża u l-volum ta' olaratumab meħtieġa biex tipprepara s-soluzzjoni għall-infużjoni.
English: Concentrate for solution for infusion 500 mg/50 mL
Maltese: 500 mg/50 mL Kunjett 1
English: This medicinal product contains 22 mg sodium per each 19 mL vial and 57 mg sodium per each 50 mL vial.
Maltese: Dan il-prodott mediċinali fih 22 mg ta' sodium għal kull kunjett ta' 19 mL u 57 mg ta' sodium għal kull kunjett ta' 50 mL.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for olaratumab, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal olaratumab, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 19 mL vial
Maltese: KARTUNA - kunjett ta' 19 mL
English: Olaratumab is a targeted, recombinant, fully human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFR-α, blocking PDGF AA, -BB, and -CC binding and receptor activation.
Maltese: Olaratumab huwa antikorp monoklonali ta' immunoglobulina G tas-sottoklassi 1 (IgG1) immirat, rikombinanti u kollu kemm hu uman li jintrabat b'mod speċifiku ma' PDGFR-α, u jimblokka l-irbit ma' PDGF AA,
English: Lartruvo is used in combination with another anti-cancer medicine called doxorubicin for the treatment of adults with advanced soft tissue sarcoma who have not been previously treated with doxorubicin.
Maltese: Lartruvo jintuża flimkien ma' mediċina oħra kontra l-kanċer imsejħa doxorubicin għat-trattament ta' adulti li għandhom sarkoma avvanzata fit-tessut l-artab u li ma kinux ittrattati preċedentement b'doxorubicin.
English: Very Common Common a Refer to NCI CTCAE Criteria (Version 4.03) for each Grade of toxicity b Musculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, groin pain,
Maltese: Komuni Ħafna Komuni a Irreferi għall-Kriterji ta' NCI CTCAE (Verżjoni 4.03) għal kull Grad ta' tossiċità b Uġigħ muskoluskeletriku jinkludi artralġja, uġigħ fid-dahar, uġigħ fl-għadam, uġigħ fil-ġenb bejn il-kustilji u l-għadma tal-ġenbejn, uġigħ fl-irqiq ta' bejn iż-żaqq u l-koxxa, uġigħ muskoluskeletriku fis-sider, uġigħ muskoluskeletriku, mijalġja, spażmi fil-muskoli, uġigħ fl-għonq,
English: In the phase 2 trial the incidence of Musculoskeletal pain was 64.1 % (all Grades) and 7.8 % (Grade 3) in the olaratumab plus doxorubicin arm and 24.6 % (all Grades) and 1.5 % (Grade 3) in the doxorubicin alone arm.
Maltese: (Grad 3) fil-fergħa ta' olaratumab flimkien ma' doxorubicin u 24.6 % (il-Gradi kollha) u 1.5 % (Grad
English: Hepatic impairment
Maltese: Avvenimenti emorraġiċi
English: No data were available from patients with severe hepatic impairment (total bilirubin > 3.0 times ULN and any AST level).
Maltese: Ma kienet disponibbli l-ebda dejta minn pazjenti b'indeboliment sever tal-fwied (bilirubin totali > 3.0 darbiet aktar mill-ULN u kwalunkwe livell ta' AST).
English: The most frequently occurring ADRs were nausea, musculoskeletal pain, neutropenia and mucositis.
Maltese: L-aktar ADRs li seħħew b'mod frekwenti kienu nawsja, uġigħ muskoluskeletriku, newtropenija u mukosite.
English: Olaratumab should be immediately and permanently discontinued in patients who experience Grade 3 or 4 IRR (see sections 4.2 and 4.8).
Maltese: • Waqqaf it-trattament b'olaratumab b'mod immedjat u permanenti (ara sezzjoni 4.4).
English: In patients who have experienced a previous Grade 1 or 2 IRR, premedication with diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone is recommended.
Maltese: F'pazjenti li qabel ikun diġà kellhom IRR ta' Grad 1 jew 2, hija rrakkomandata premedikazzjoni b'diphenhydramine hydrochloride (mill-vini), paracetamol, u dexamethasone, flimkien ma'
English: If not used immediately, the dosing solution should be stored under refrigeration for up to 24 hours at 2 °C to 8 °C and up to an additional 8 hours at room temperature (up to 25 °C) assuming dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma tintużax immedjatament, is-soluzzjoni għall-għoti taddoża għandha tinħażen fi friġġ għal mhux aktar minn 24 siegħa f'temperatura ta' 2 °C sa 8 °C u għal 8 sigħat addizzjonali f'temperatura ambjentali (sa 25 °C) jekk wieħed jassumi li d-dilwizzjoni saret f'kundizzjonijiet asettiċi kkontrollati u vvalidati.
English: Add a sufficient quantity of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to make the total volume 250 mL.
Maltese: Żid kwantità biżżejjed ta' soluzzjoni ta' sodium chloride 9 mg/mL (0.9 %) għall-injezzjoni ġol-kontenitur biex iġġib il-volum totali lura għal 250 mL.
English: Only use sodium chloride 9 mg/mL (0.9 %) solution for injection as a diluent.
Maltese: Uża biss soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9 %) bħala dilwent.
English: Breast-feeding
Maltese: Limfopenija
English: There are very limited data regarding olaratumab administration in patients with moderate hepatic impairment.
Maltese: Hemm dejta limitata ħafna dwar l-għoti ta' olaratumab f'pazjenti b'indeboliment moderat tal-fwied.
English: Handling instructions Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Maltese: Informazzjoni għall-utent Lartruvo 10 mg/mL konċentrat għal soluzzjoni għall-infużjoni olaratumab
English: For patients who experience Grade 1 or 2 IRR, the infusion should be interrupted and paracetamol, H1 antagonist and dexamethasone (or equivalent medicinal products) administered as needed.
Maltese: Għal pazjenti li jkollhom IRR (infusion-related reaction-reazzjoni kkawżata mill-infużjoni)) ta' Grad 1 jew 2, l-infużjoni għandha titwaqqaf u għandhom jingħataw paracetamol, antagonist tarriċettur H1 u dexamethasone (jew prodotti mediċinali ekwivalenti) skont il-ħtieġa.
English: Not applicable.
Maltese: olaratumab.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with olaratumab in one or more subsets of the paediatric population in soft tissue sarcoma (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'olaratumab f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika f'sarkoma fit-tessut artab (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Anthracycline pre-treated patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: - The other ingredients are mannitol, glycine, L-histidine monohydrochloride monohydrate, L-histidine, sodium chloride (see section 2 “Lartruvo contains sodium”), polysorbate 20 and water for injections.
Maltese: L-histidine, sodium chloride (ara sezzjoni 2 “Lartruvo fih sodium”), polysorbate 20 u ilma għall-injezzjonijiet.
English: • For subsequent infusions, please see premedication section.
Maltese: • Għal infużjonijiet sussegwenti, jekk jogħġbok ara s-sezzjoni ta' premedikazzjoni.
English: For dosage adjustments related to neutropenia, refer to section 4.2.
Maltese: Għall aġġustamenti fid-doża irreferi għal sezzjoni 4.2.
English: • Feeling faint
Maltese: FEJN MA
English: Olaratumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Maltese: IgG1 uman magħmul fiċ-ċelluli ta' annimali gerriema (NS0)
English: Elderly (> 65 years)
Maltese: Medjan (95 % CI)
English: 3 patients in the olaratumab plus doxorubicin arm and 1 patient in the doxorubicin arm had post-study surgery only.
Maltese: 3 pazjenti fil-fergħa ta' olaratumab flimkein ma' doxorubicin u pazjent 1 fil-fergħa ta' doxorubicin kellhom biss operazzjoni kirurġika wara l-istudju.
English: Neutropenia
Maltese: Mukosite
English: Concentrate for solution for infusion 190 mg/19 mL
Maltese: 190 mg/19 mL Kunjett 1
English: As doxorubicin is rapidly metabolised and predominantly eliminated by the biliary system, the toxicity of doxorubicin is enhanced in patients with hepatic impairment.
Maltese: Indeboliment epatiku Peress li doxorubicin jiġi mmetabolizzat malajr u jiġi eliminat l-aktar permezz tas-sistema biljari, it tossiċità ta' doxorubicin tiżdied f'pazjenti b'indeboliment epatiku.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 50 mL vial
Maltese: TIKKETTA TAL-KUNJETT - kunjett ta' 50 mL
English: The rate of febrile neutropenia was 12.5 % in the olaratumab plus doxorubicin arm and 13.8 % in the doxorubicin alone arm. For dose adjustments, refer to section 4.2
Maltese: Ir-rata ta' newtropenija bid-deni kienet ta' 12.5 % fil-fergħa ta' olaratumab flimkien ma' doxorubicin u ta' 13.8 % fil-fergħa ta' doxorubicin waħdu.
English: For subsequent infusions, the dose should be reduced to 12 mg/kg for serious Grade 3 toxicities and to 10 mg/kg for Grade 4 toxicities.
Maltese: Grad 3 minkejja it-tnaqqis fid-doża,id-doża għandha titnaqqas iżjed għal 10 mg/kg.
English: In case of prefilled intravenous infusion container usage Based on the calculated volume of olaratumab, the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection should be removed from the prefilled 250 mL intravenous container.
Maltese: Abbażi tal-volum ikkalkulat ta' olaratumab, il-volum korrispondenti ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9 %) għandu jiġi mneħħi mill-kontenitur mimli għal-lest ta' 250 mL għal għoti mill-vini.
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: KONDIZZJONALI Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14(7) tar
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of concentrate for solution for infusion contains 10 mg of olaratumab.
Maltese: U KWANTITATTIVA Millilitru wieħed ta' konċentrat għal soluzzjoni għall-infużjoni fih 10 mg ta' olaratumab.
English: Data on very elderly patients (> 75 years) are very limited (see sections 4.8 and 5.1).
Maltese: Anzjani (> 65 sena) Id-dejta dwar pazjenti anzjani ħafna (> 75 sena) hija limitata ħafna (ara sezzjonijiet 4.8 u 5.1).
English: All patients receiving more than 4 cycles of doxorubicin received dexrazoxane.
Maltese: Il-pazjenti kollha li rċivew aktar minn 4 ċikli ta' doxorubicin rċivew dexrazoxane.
English: In the event that intravenous administration of an H1 antagonist is not possible, equivalent alternative premedication should be given (e.g. oral diphenhydramine hydrochloride at least 90 minutes prior to the infusion).
Maltese: F'każ li l-għoti ta' antagonist tar-riċettur H1 mill-vini ma jkunx possibbli, għandha tingħata premedikazzjoni alternattiva ekwivalenti (eż. diphenhydramine hydrochloride mill-ħalq mill-inqas
English: The main analysis was performed in the following two subgroups: Leiomyosarcoma (LMS) and non-LMS (other).
Maltese: L-analiżi prinċipali saret fiż-żewġ sottogruppi li ġejjin: Leiomyosarcoma
English: The rate of cardiac arrhythmias was similar in both arms (15.6 % in the Investigational Arm and 15.4 % in the Control Arm).
Maltese: Ir-rata ta' arritmiji tal-qalb kienet tixxiebah fiż-żewġ fergħat (15.6 % fil-Fergħa ta' Investigazzjoni u 15.4
English: NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL sterile concentrate olaratumab
Maltese: Istruzzjonijiet dwar l-immaniġġar Lartruvo 10 mg/mL
English: Non-clinical data reveal no special hazard for humans based on repeat dose toxicity studies in monkeys.
Maltese: Inti se tingħata mediċini biex tnaqqas ir-riskju ta' reazzjoni marbuta mal-infużjoni qabel ma inti tirċievi Lartruvo.
English: A total of 133 patients were randomised, of whom 129 received at least one dose of study treatment (64 in the olaratumab plus doxorubicin arm and 65 in the doxorubicin arm).
Maltese: Total ta' 133 pazjent intagħżlu b'mod arbitrarju, li minnhom 129 irċivew mill-inqas doża waħda tat-trattament tal-istudju (64 fil-fergħa ta' olaratumab flimkien ma' doxorubicin u 65 fil-fergħa ta' doxorubicin).
English: If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC and up to an additional 8 hours at room temperature (below 25 ºC).
Maltese: Jekk ma tintużax immedjatament, il-ħinijiet u l-kondizzjonijiet tal-ħażna qabel u waqt l-użu huma r-resposabbiltà ta' min ikun qed jużaha u s-soltu ma jkunux aktar minn 24 siegħa f'temperatura ta' 2 sa 8 ºC u sa 8 sigħat addizzjonali f'temperatura ambjentali (taħt 25 ºC).
English: The efficacy and safety of olaratumab was assessed in a Phase 1b/2, multi-centre study in anthracycline naïve patients with histologically or cytologically confirmed, advanced soft tissue sarcoma not amenable to receive surgery or radiotherapy with curative intent.
Maltese: L-effikaċja u s-sigurtà ta' olaratumab ġew ivvalutati fi studju ta' Fażi 1b/2 b'ħafna ċentri f'pazjenti li qatt ma kienu ħadu anthracycline qabel li kellhom sarkoma fit-tessut artab ikkonfermata b'mod istoloġiku jew ċitoloġiku li ma setgħetx tiġi kkurata b'operazzjoni jew radjuterapija.
English: Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Maltese: Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10
English: In order to further confirm the efficacy and safety of olaratumab in the treatment of patients with advanced soft tissue sarcoma, the MAH should submit the clinical study report of the phase III study JGDJ comparing doxorubicin plus olaratumab versus doxorubicin in patients with advanced or metastatic STS (including exploratory biomarker data).
Maltese: JGDJ li jqabbel doxorubicin flimkien ma' olaratumab kontra doxorubicin f'pazjenti b'STS avvanzata jew metastatika (inkluż tagħrif esploratorju ta' bijomarker).
English: Very Common None reported
Maltese: Komuni Ħafna Komuni Ħafna
English: There are no data in patients with severe hepatic impairment (see section 5.2).
Maltese: Ma hemm l-ebda dejta f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 5.2).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL - 19 mL vial
Maltese: TIKKETTA TAL-KUNJETT - kunjett ta' 19 mL
English: Patients should be monitored during the infusion for signs and symptoms of infusion-related reactions (IRRs) in a setting with available resuscitation equipment (see section 4.4).
Maltese: Matul l-infużjoni l-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' reazzjonijiet marbuta mal infużjoni (IRRs - infusion-related reactions) f'ambjent fejn ikun hemm apparat disponibbli għal risuxxitazzjoni (ara sezzjoni 4.4).
English: • Paracetamol, H1 antagonist and dexamethasone should be administered as needed (see premedication section)
Maltese: • Paracetamol, antagonist tar-riċettur H1 u dexamethasone għandhom jingħataw skont il-ħtieġa (ara s-sezzjoni ta' • Ladarba r-reazzjoni tgħaddi, erġa' kompli l-infużjoni b'rata
English: Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1).
Maltese: Lartruvo huwa indikat flimkien ma' doxorubicin għat-trattament ta' pazjenti adulti b'sarkoma avvanzata fit-tessut artab li ma jkunux jistgħu jieħdu trattament ta' kura permezz ta' operazzjoni jew radjuterapija u li qatt ma kienu ġew ittrattati b'doxorubicin qabel (ara sezzjoni 5.1).
English: Neutrophil count should be monitored during the treatment with olaratumab and doxorubicin and supportive care should be administered such as antibiotics or G-CSF as per local guidelines.
Maltese: L-għadd newtrofiliku għandu jiġi ċċekkjat waqt it-trattament b'olaratumab u doxorubicin u għandha tingħata kura ta' sostenn bħal antibijotiċi jew G-CSF skont kif hemm fil-linji gwida lokali.
English: There is no known antidote to Lartruvo overdose.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride
Maltese: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride