FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on individual clinical response and tolerability, each dose can be further increased in weekly increments of 2.5 mg/kg administered twice daily (5 mg/kg/day) up to a maximum recommended dose of 10 mg/kg twice daily (20 mg/kg/day).
Maltese: Abbażi tar-rispons kliniku u t-tollerabilità individwali, kull doża tista' tiżdied aktar f'inkrementi ta' kull ġimgħa ta' 2.5 mg/kg li jingħataw darbtejn kuljum (5 mg/kg/jum) sad-doża massima rakkomandata ta' 10 mg/kg/jum darbtejn kuljum (20 mg/kg/jum).
English: d The Overall p-value is based on a Cochran-Mantel-Haenszel test; the nominal p-value for the with clobazam subgroup is based on logistic regression analysis.
Maltese: d Il-Valur-p globali huwa bbażat fuq test ta' Cochran-Mantel-Haenszel; il-valuri-p nominali għas-sottogrupbi clobazam huma bbażati fuq analiżi tar-rigressjoni loġistika
English: The responder rate analysis also showed a correlation in the exposure-response relationship for the active metabolite of cannabidiol (7-OH-CBD).
Maltese: L-analiżi tar-rata ta' dawk li rrispondew uriet ukoll korrelazzjoni fir-relazzjoni ta' bejn l-esponiment u r-rispons għall-metabolit attiv ta' cannabidiol (7-OH-CBD).
English: Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.
Maltese: Epidyolex huwa indikat għall-użu bħala terapija aġġuntiva għal aċċessjonijiet assoċjati mas-sindrome ta' Lennox-Gastaut (LGS, Lennox-Gastaut syndrome) jew is-sindrome ta' Dravet (DS, Dravet syndrome) flimkien ma' clobazam, għal pazjenti li jkollhom sentejn jew aktar.
English: GWPCARE4 Placebo 20 mg/kg/day p=0.0043
Maltese: Plaċebo 20 mg/kg/jum p = 0.0043
English: After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice daily (10 mg/kg/day).
Maltese: Wara ġimgħa, id-doża għandha tiżdied għal doża ta' manteniment ta' 5 mg/kg darbtejn kuljum (10 mg/kg/jum).
English: Baseline transaminase elevations
Maltese: Żidiet fil-Livelli ta' transaminases fil-linja bażi
English: Skin and subcutaneous tissue disorders Common
Maltese: Tossiċità fil-firien żgħażagħ
English: After multiple dosing with cannabidiol, the 7-OH-CBD metabolite (active in a preclinical model of seizure) circulates in human plasma at lower concentrations than the parent drug cannabidiol (~ 40% of CBD exposure) based on AUC.
Maltese: Wara dożaġġ multiplu b'cannabidiol, il-metabolit 7-OH-CBD (attiv f'mudell tal-aċċessjonijiet ta' qabel l-użu kliniku) jiċċirkola fil-plażma umana f'konċentrazzjonijiet fil-plażma aktar baxxi minn dawk tal-mediċina prinċipali cannabidiol (~ 40% tal-esponiment għal CBD) abbażi tal-AUC.
English: Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted: - other epilepsy medicines, such as carbamazepine, clobazam, lamotrigine, lorazepam,
Maltese: Għid lit-tabib jekk qed tieħu xi waħda minn dawn il-mediċini li ġejjin, għax id-doża tiegħek jaf ikollha bżonn tiġi aġġustata: - mediċini oħra tal-epilessija, bħal carbamazepine, clobazam, lamotrigine, lorazepam, midazolam,
English: The bottle is packaged in a carton with two 5 ml and two 1 ml calibrated oral dosing syringes (plunger HDPE and barrel polypropylene) and two bottle adapters (LDPE).
Maltese: Il-flixkun huwa ppakkjat f'kartuna b'żewġ siringi tal-ħalq għad-dożaġġ ikkalibrati ta' 5 mL u tnejn oħra ta' 1 mL (planġer tal-HDPE u bettija tal polypropylene) u żewġ adapters tal-flixkien (LDPE).
English: The embryo-foetal development (EFD) study performed in rabbits evaluated doses of 50, 80, or 125 mg/kg/day.
Maltese: L-istudju dwar l-iżvilupp embrijo-fetali (EFD, embryo-foetal development) li sar fil-fniek evalwa dożi ta' 50, 80 jew 125 mg/kg/jum.
English: PHARMACEUTICAL FORM Oral solution
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni orali
English: Cannabidiol is predominantly cleared by metabolism in the liver and gut and excreted in faeces, with renal clearance of parent drug being a minor pathway.
Maltese: Cannabidiol huwa primarjament eliminat mill-metaboliżmu fil-fwied u l-imsaren, u eliminat fl-ippurgar, bit-tneħħija renali tal-mediċina primarja bħala passaġġ minuri.
English: In LGS and DS patients, the decrease in weight appeared to be dose-related, with 19% of patients on cannabidiol 20 mg/kg/day experiencing a decrease in weight ≥ 5%, compared to 8% in patients on cannabidiol 10 mg/kg/day.
Maltese: F' pazjenti b'LGS u DS, it, tnaqqis fil-piż deher li kien relatat mad-doża, b'19% tal-pazjenti fuq cannabidiol 20 mg/kg/jum ikollhom tnaqqis fil-piż ta' ≥ 5% meta mqabbla ma' 8% fil-pazjenti fuq cannabidiol 10 mg/kg/jum.
English: Hypersensitivity to the active substance, to sesame oil, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għaż-żejt tal-ġunġlien, jew għal kwalunkwe sustanza mhux attiva oħra elenkata fis-sezzjoni 6.1.
English: • If your dose is more than 5 ml (500 mg), you will need to use the larger 5 ml syringe more than once.
Maltese: • Jekk id-doża tiegħek hija ta' aktar minn 5 mL (500 mg), għandek tuża s-siringa akbar ta' 5 mL għal aktar minn darba.
English: Cough
Maltese: L-UŻU
English: Data for study GWPCARE2 and the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Maltese: Id-dejta għall-istudju GWPCARE2 u għas-sottogrupp bi clobazam hija stmata minn analiżi ta' rigressjoni binomjali negattiva.
English: Lethargy, Drooling, Tremor
Maltese: Letarġija, Legħba, Rogħda
English: Cannabidiol appears rapidly in plasma with a time to maximum plasma concentration of 2.5-5 hours at steady state.
Maltese: Cannabidiol jidher malajr fil-plażma b'ħin għal biex tintlaħaq il-konċentrazzjoni massima fil-plażma ta' 2.5-5 sigħat fl-istat fiss.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Key secondary endpoints were the proportion of patients with at least a 50% reduction in drop seizure frequency, the percentage change from baseline in total seizure frequency, and Subject/Caregiver Global Impression of Change at the last visit.
Maltese: Il-punti ta' tmiem sekondarji kienu l-proporzjon ta' pazjenti li kellhom mill-inqas tnaqqis ta' 50% fil-frekwenza ta' aċċessjonijiet atoniċi, il-bidla perċentwali mil-linja bażi fil-frekwenza totali ta' aċċessjonijiet, u Impressjoni Globali tal-Bidla tal-Individwu/Persuna li Tieħu Ħsieb il-Pazjent fl-aħħar żjara.
English: The primary endpoint was the change in convulsive seizure frequency during the treatment period (Day 1 to the end of the evaluable period) compared to baseline (GWPCARE2), and the percentage change from baseline in convulsive seizures per 28 days over the treatment period (GWPCARE1) for the cannabidiol groups compared to placebo.
Maltese: Il-punt ta' tmiem primarju kien bidla fil-frekwenza ta' aċċessjonijiet konvulżivi matul il-perjodu ta' trattament (Jum 1 sat-tmiem tal-perjodu li jista' jiġi evalwat) meta mqabbel mal-linja bażi (GWPCARE2) u mal-bidla perċentwali medja mil-linja bażi fl-aċċessjonijiet konvulżivi għal 28 jum matul il-perjodu ta' trattament (GWPCARE1) għall-gruppi ta' cannabidiol meta mqabbel mal-plaċebo.
English: Amber glass bottle (type III) with a child-resistant and tamper-evident screw cap (polypropylene).
Maltese: L-esperjenza b'dożi ogħla mid-doża terapewtika rakkomandata hija limitata.
English: Although no formal drug-drug interaction studies have been performed for other AEDs, phenytoin and lamotrigine are addressed based on in vitro data.
Maltese: Għalkemm ma saru l-ebda studji formali dwar interazzjonijiet bejn mediċina u oħra għal AEDs oħra, phenytoin u lamotrigine huma indirizzati abbażi ta' dejta in-vitro.
English: In the event of overdose the patient should be observed and appropriate symptomatic treatment given, including monitoring of vital signs.
Maltese: F'avveniment ta' doża eċċessiva, il-pazjenti għandu jiġi osservat u jingħata trattament sintomatiku xieraq, inkluż monitoraġġ ta' sinjal vitali.
English: Refined sesame oil
Maltese: Żejt tal-ġulġlien raffinat
English: The clinical relevance of this is unknown, but the patient should be closely monitored for adverse drug reactions.
Maltese: Ir-rilevanza klinika ta' dan mhux magħrufa, iżda l-pazjent għandu jiġi mmonitorjat mill-qrib għar-reazzjonijiet avversi tal-mediċina.
English: How to store Epidyolex.
Maltese: - tieqaf tieħu Epidyolex f'daqqa.
English: No effect on cannabidiol levels.
Maltese: L-ebda effett fuq il-livelli ta' cannabidiol.
English: If the calculated dose is more than 100 mg (1 ml), the larger 5 ml oral syringe should be used.
Maltese: Jekk id-doża kkalkulata tkun aktar minn 100 mg (1 mL), għandha tintuża s-siringa tal-ħalq akbar ta' 5 mL.
English: If clinically significant increases of transaminases occur, cannabidiol and/or concomitant valproate should be reduced or discontinued in all patients until a recovery of transaminase elevations are observed (see section 4.4).
Maltese: Jekk iseħħu żidiet klinikament sinifikanti fil-livell ta' transaminases, cannabidiol u/jew valproate mogħti fl-istess ħin għandu jitnaqqas jew jitwaqqaf fil-pazjenti kollha sakemm jiġi osservat irkupru fiż-żidiet fil-livelli ta' transaminase (ara sezzjoni 4.4).
English: What Epidyolex looks like and contents of the pack Epidyolex is a clear, colourless to yellow oral solution.
Maltese: Jekk tieħu Epidyolex mal-ikel dan jista' jżid l-ammont tal-mediċina li jassorbi ġismek.
English: Study 005/05
Maltese: Studju 005/05
English: Metabolism/elimination
Maltese: Metaboliżmu/eliminazzjoni
English: Overall response rate (% CR, % PR)
Maltese: Rata ta' rispons globali (% CR, % PR)
English: Exploratory subgroups
Maltese: Sottogruppi esploratorji
English: 2°C to 8°C
Maltese: 2°C sa 8°C
English: Vitiligo, Rash, Dermatitis
Maltese: Vitiligo, Raxx, Dermatite
English: up to 25°C
Maltese: sa 25°C
English: 30th June, 2021
Maltese: 30 ta' Ġunju, 2021
English: Kaplan-Meier plot -overall survival (ITT population)
Maltese: Kaplan-Meier plot - sopravivenza globali (popolazzjoni ITT)
English: - The active substance is talimogene laherparepvec.
Maltese: - Is-sustanza attiva hi talimogene laherparepvec.
English: • Allergic reaction (hypersensitivity)
Maltese: • Reazzjoni allerġika (sensittività eċċessiva)
English: Immunocompromised patients
Maltese: Pazjenti immunokompromessi
English: 2.2 Qualitative and quantitative composition
Maltese: 2.2 Għamla kwalitattiva u kwantitattiva
English: Up to 4 mL
Maltese: Sa 4 mL
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 December 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 16 ta' Diċembru 2015
English: Stage§ IIIB/IIIC/ stage IVM1a (Imlygic, n = 163; GM-CSF, n = 86)
Maltese: IIIB/IIIC/ stadju IVM1a (Imlygic, n = 163; GM-CSF, n = 86)
English: Talimogene laherparepvec is sensitive to acyclovir.
Maltese: Talimogene laherparepvec hu sensittiv għal acyclovir.
English: Clinical biodistribution, elimination, and shedding
Maltese: Bijodistribuzzjoni klinika, eliminazzjoni, u tixrid
English: Immune-mediated events†*
Maltese: Avvenimenti medjati mis-sistema immunitarja†*
English: 1: GM-CSF (N = 86) Median (95% CI) 21.5 (17.4, 29.6) months 2: Talimogene Laherparepvec (N = 163) Median (95% CI) 41.1 (30.6, NE) months
Maltese: (N = 86) Medjan (95% CI) 21.5 (17.4, 29.6) months 2: Talimogene Laherparepvec (N = 163) Medjan (95% CI) 41.1 (30.6, NE) months
English: Table 8.
Maltese: Tabella 8.
English: • Tissue swelling (peripheral oedema)
Maltese: • Nefħa fit-tessuti (oedema periferali)
English: 5 (19%)a aFor the anogenital area, 26 patients were tested for Imlygic DNA.
Maltese: 5 (19%)a a Għall-erja anoġenitali, 26 pazjent ġew ittestjati għal DNA ta' Imlygic.
English: Di-sodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol (E420), water for injections.
Maltese: Di-sodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol (E420), ilma għall-injezzjonijiet.
English: Secondary
Maltese: Sekondarju
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Maltese: U KWANTITATTIVA 2.1 Deskrizzjoni ġenerali
English: Cellulitis*, Oral herpes
Maltese: Ċellulite*, Erpete orali
English: 8 hours up to 25°C
Maltese: 8 sigħat sa 25°C
English: 106 (1 million) PFU/mL 108 (100 million) PFU/mL
Maltese: 106 (1 miljun) PFU/mL 108 (100 miljun) PFU/mL
English: HSV-1 seronegative patients
Maltese: Pazjenti b'HSV-1 seronegattivi
English: Talimogene laherparepvec is a genetically modified and replication-competent HSV-1 virus.
Maltese: Talimogene laherparepvec hu ġenetikament modifikat u virus HSV-1 kompetenti għar-replikar.
English: Log-rank p-value = 0.0511 Hazard Ratio [95% CI] = 0.79 [0.62, 1.00]
Maltese: Valur p log-reank = 0.0511 Proporzjon ta 'periklu [95% CI] = 0.79 [0.
English: > 5 cm up to 4 mL
Maltese: > 5 ċm sa 4 mL
English: 8 hours
Maltese: 8 sigħat
English: Imlygic has not been studied in immunocompromised patients.
Maltese: Imlygic ma ġiex studjat fuq pazjenti immunokompromessi.
English: Lethal systemic viral infection was observed in up to 20% of nude mice (primarily deficient in T lymphocyte function) and 100% of SCID mice (devoid of both T and B lymphocytes).
Maltese: Kienet osservata infezzjoni virali sistemika letali f'sa 20% tal-ġrieden nudi (primarjament defiċjenti fil-funzjoni tallimfoċiti T) u 100% tal-ġrieden SCID (mingħajr limfoċiti T u B).
English: Talimogene laherparepvec was injected into various xenograft tumours at doses up to 2 x 108 PFU/kg (30-fold over the highest proposed clinical dose) in immunodeficient mice (nude and SCID).
Maltese: Talimogene laherparepvec kien injettat f'diversi tumuri xenograft f'dożi sa 2 x 108 PFU/kg (30 darba aktar mill-ogħla doża klinika proposta) fi ġrieden immunodefiċjenti (nudi u SCID).
English: Acyclovir and other anti-viral treatments may decrease the effects of Imlygic.
Maltese: Acyclovir u trattamenti oħra antivirali jistgħu jnaqqsu l-effetti ta' Imlygic.
English: 8.2 months (95% CI: 6.5, 9.9)
Maltese: 8.2 xhur (95% CI: 6.5, 9.9)
English: Each 4 mL dose contains approximately 30 mg (1.3 mmol) sodium and 80 mg sorbitol.
Maltese: Kull doża ta' 4 mL fiha madwar 30 mg (1.3 mmol) sodju u 80 mg sorbitol.
English: To provide preliminary efficacy results from the phase III part of the Study 20110265 (a multicentre trial evaluating the combination of talimogene laherparepvec with pembrolizumab)
Maltese: III ta' Studju 20110265 (prova multiċentrika li evalwat il-kombinazzjoni ta' talimogene laherparepvec ma' pembrolizumab)
English: This medicinal product contains 80 mg sorbitol (E420) per 4 mL dose.
Maltese: Dan il-prodott mediċinali fih 80 mg sorbitol (E420) kull doża ta' 4 mL.
English: Median 2.8 months (Range: 1.2 to > 14.9 months)
Maltese: Medjan 2.8 xhur (Firxa: 1.2 to > 14.9 xhur)
English: 2.9 months (95% CI: 2.8, 4.0) HR: 0.42; (95% CI: 0.32, 0.54)
Maltese: 2.9 xhur (95% CI: 2.8, 4.0) HR: 0.42; (95% CI: 0.32, 0.54)
English: ≤ 0.5 cm up to 0.1 mL
Maltese: ≤ 0.5 ċm sa 0.1 mL
English: 2.1% (n = 3) (95% CI: 0.0, 4.5) Odds ratio 8.9; (95% CI: 2.7, 29.2) P < 0.0001
Maltese: 2.1% (n = 3) (95% CI: 0.0, 4.5) Proporzjon ta' probabbilità 8.9; (95% CI: 2.7, 29.2) P < 0.0001
English: In an analysis to evaluate systemic activity of Imlygic, 27 of 79 patients (34.2%) had a ≥ 50% overall decrease in non-visceral lesions that were not injected with Imlygic, and 8 of 71 patients (11.3%) had a ≥ 50% overall decrease in visceral lesions that were not injected with Imlygic.
Maltese: F'analiżi għall-evalwazzjoni ta' attività sistemika b'Imlygic, 27 minn 79 pazjent (34.2%) kellhom tnaqqis globali ta' ≥ 50% fil-feriti mhux vixxerali li ma kinux injettati b'Imlygic, u 8 minn 71 pazjent (11.3%) kellhom tnaqqis globali ta' ≥ 50% fil-feriti vixxerali li ma kinux injettati b'Imlygic.
English: Name and address of the manufacturer of the biological active substance BioVex Inc. - Subsidiary of Amgen, Inc.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva BioVex Inc.
English: Do not exceed the storage times specified in table 7 and table 8.
Maltese: Taqbiżx ilħinijiet tal-ħażna speċifikati f'tabella 7 u tabella 8.
English: Patients with detectable DNA during treatment (n = 60)
Maltese: Pazjenti b'DNA osservabbli matul ittrattament (n = 60)
English: • Symptomatic herpetic infection due to latency and reactivation of IMLYGIC or herpes (wildtype HSV-1) in patients
Maltese: • Infezzjoni erpetika sintomatika minħabba latenza u attivazzjoni mill-ġdid ta' IMLYGIC jew herpes (wild-type HSV-1) fil-pazjenti
English: GRH0149v1
Maltese: GRH0279MTv1
English: Table 7.
Maltese: Tabella 7.
English: Median 18.9 (95% CI: 16.0, 23.7) months
Maltese: Medjan 18.9 (95% CI: 16.0, 23.7) xhur
English: Talimogene laherparepvec DNA was quantified with a highly sensitive and specific quantitative Polymerase Chain Reaction (qPCR) assay which may not correlate with viral infectivity risk.
Maltese: Id-DNA ta' talimogene laherparepvec kien ikkwantifikat b'assaġġ sensittiv ħafna u speċifikat ta' quantitative Polymerase Chain Reaction (qPCR) li jista' ma jikkorrelatax ma' riskji ta' infettività virali.
English: (1 million) PFU/mL
Maltese: (1 miljun) PFU/mL
English: • Dehydration
Maltese: • Deidrazzjoni
English: Stage§ IVM1B/ IVM1C (Imlygic, n = 131;
Maltese: IVM1B/ IVM1C (Imlygic, n = 131; GM-CSF, n = 55)
English: If healthcare professionals are accidentally exposed to Imlygic, see sections 4.4 and 6.6.
Maltese: Jekk il-professjonisti tal-kura tas-saħħa jkunu inċidentalment esposti għal Imlygic, ara sezzjonijiet 4.4 u 6.6.
English: Transplacental metastases of malignant melanoma can occur.
Maltese: Tista' sseħħ metastasi mill-plaċenta ta' melanoma malinna.
English: • Tumour pain, infected tumour
Maltese: • Uġigħ fit-tumur, tumur infettat
English: Median 23.3 (95% CI: 19.5, 29.6) months
Maltese: Medjan 23.3 (95% CI: 19.5, 29.6) xhur
English: 4 hours
Maltese: 4 sigħat
English: Treatment interval
Maltese: Intervall tattrattament
English: Store and transport frozen at -90°C to -70°C.
Maltese: Aħżen u ttrasporta fil-friża f'temperatura ta' -90°C sa -70°C.
English: Overall, 58% of all patients enrolled into the study were seropositive for wild-type HSV-1 at baseline and 32.6% were seronegative; the HSV-1 serostatus of the remaining 9.4% was unknown.
Maltese: Globalment, 58% tal-pazjenti kollha involuti fl-istudju kienu seropożittivi għal HSV-1 tat-tip selvaġġ fil-linja bażi u 32.6% kienu seronegattivi; l-istat sero ta' HSV-1 tad-9.4% li jifdal ma kienx magħruf.
English: Kaplan-Meier estimate of overall survival by randomised treatment arm for disease stage IIIB/IIIC/ stage IVM1a (exploratory subgroup analysis)
Maltese: L-estimi ta' Kaplan-Meier tas-sopravivenza globali mill-grupp li ntgħażel b'mod każwali tat-trattament għall-istadju IIIB/IIIC/ stadju IVM1a tal-marda (analiżi esploratorja tas-sottogrupp)
English: At doses up to 4 x 108 PFU/kg or 107 PFU/dose (60-fold over the highest proposed clinical dose), single or repeated doses of talimogene laherparepvec administered by SC, IV, or intratumoural injection were well tolerated in immunocompetent mice, rats, and dogs.
Maltese: F'dożi sa 4 x 108 PFU/kg jew 107 PFU/doża (60 darba aktar mill-ogħla doża klinika proposta), doża waħda jew ripetuta ta' talimogene laherparepvec mogħtija taħt il-ġilda (subcutaneous, SC), ġol-vini (intravenous, IV), jew b'injezzjoni ġot-tumur kienu tollerati tajjeb fi ġrieden, firien, u klieb immunokompetenti.
English: Figure 1.
Maltese: Stampa 1.
English: In the pivotal clinical trial (study 005/05), events of cellulitis were recorded, some of them being considered as serious adverse events.
Maltese: Fil-prova klinika kruċjali (studju 005/05), l-avvenimenti ta' ċellulite ġew irreġistrati, u xi wħud minnhom kienu kkunsidrati li kienu avvenimenti avversi serji.
English: Whereas anti-viral immune responses defend normal cells following infection by talimogene laherparepvec, tumours have been shown to be susceptible to injury and cell death from ICP34.5deficient HSV-1 viruses, including talimogene laherparepvec.
Maltese: Filwaqt li r-risponsi immuni antivirali jiddefendu ċ-ċelloli normali wara infezzjoni b'talimogene laherparepvec, intwera li t-tumuri huma suxxettibbli għal korrimenti u mwiet ta' ċelloli minn viruses ICP34.5-defiċjenti HSV-1, li jinkludu talimogene laherparepvec.
English: Figure 5.
Maltese: Stampa 5.
English: Talimogene laherparepvec is cleared through general host-defence mechanisms (e.g. autophagy, adaptive immune responses).
Maltese: Talimogene laherparepvec jitneħħa b'mekkaniżmi ġenerali ta' difiża (host-defence) (eż. awtofaġija, risponsi immuni adattivi).
English: Imlygic contains sodium and sorbitol
Maltese: Imlygic fih is-sodju u s-sorbitol
English: (100 million) PFU/mL
Maltese: (100 miljun) PFU/mL
English: Summary of results from exploratory subgroup analysis from Imlygic study 005/05
Maltese: Sommarju tar-riżultati minn analiżi esploratorja tas-sottogrupp mill-istudju 005/05 ta' Imlygic
English: Figure 2.
Maltese: Stampa 2.
English: Talimogene laherparepvec has been modified to replicate within tumours and to produce the immune stimulatory protein human GM-CSF.
Maltese: Talimogene laherparepvec ġie mmodifikat biex jirreplika fit-tumuri u biex jipproduċi l-proteina umana stimulanti immuna GM-CSF.
English: • Guide for healthcare professionals shall contain the following key elements: o Information on the risk of herpetic infection in patients treated by IMLYGIC o Information on the risk of disseminated herpetic infection in immunocompromised individuals treated by IMLYGIC o Recommendation regarding accidental exposure of IMLYGIC to HCPs: o To always wear protective gown/laboratory coat, safety glasses and gloves while preparing or administrating IMLYGIC; o To avoid contact with skin, eyes, mucous membranes and ungloved direct contact with injected lesions or body fluids of treated patients; o Instruction on first aid after accidental exposure; o Immunocompromised and pregnant healthcare professionals should not prepare and administer IMLYGIC.
Maltese: • Il-Gwida għall-professjonisti fil-qasam mediku għandu jkun fiha l-elementi ewlenin li ġejjin: o Informazzjoni dwar ir-riskju ta' infezzjoni erpetika f'pazjenti ttrattati b'IMLYGIC o Informazzjoni dwar ir-riskju ta' infezzjoni erpetika mifruxa f'pazjenti immunokompromessi ttrattati b'IMLYGIC o Rakkomandazzjoni dwar esponiment aċċidentali ta' IMLYGIC lil HCPs: o Biex dejjem jilbsu libsa protettiva jew il-ġigaga tal-laboratorju, nuċċali tas-sigurtà u ingwanti waqt il-preparazzjoni jew l-għoti ta' IMLYGIC; o Biex jiġi evitat kuntatt mal-ġilda, għajnejn, membrani mukużi u kuntatt dirett ta' idejn mingħajr ingwanti ma' leżjonijiet infettati jew fluwidi tal-ġisem ta' pazjenti ttrattati; o Istruzzjonijiet dwar l-ewwel għajnuna wara esponiment aċċidentali; o Professjonisti fil-qasam mediku immunokompromessi u tqal m'għandhomx jippreparaw u jagħtu IMLYGIC.
English: • Accidental exposure of Healthcare Professionals (HCPs) to IMLYGIC
Maltese: • Esponiment aċċidentali ta' Professjonisti fil-Qasam Mediku tas-saħħa (Healthcare Professionals, HCPs) għal IMLYGIC
English: To submit the preliminary results from Study 20110266 (a phase 2, multicentre, randomised, open-label trial assessing the efficacy and safety of talimogene laherparepvec neoadjuvant treatment plus surgery vs surgery alone for resectable stage IIIB to IVM1a melanoma)
Maltese: Biex jiġu sottomissi r-riżultati preliminari minn Studju 20110266 (prova ta' fażi 2, multiċentrika, li fiha l-parteċipanti ntgħażlu b'mod każwali, open-label, li evalwat l-effikaċja u s-sigurtà tat-trattament neoadjuvant b'talimogene laherparepvec flimkien ma' kirurġija kontra kirurġija waħidha, għal melanoma li tista' tinqata, ta' stadju IIIB sa IVM1a)
English: 2 hours
Maltese: 2 sigħat