FrancophonIA/ELRC3.0 huggingface dataset:
English: > 0.5 cm to 1.5 cm up to 0.5 mL
Maltese: > 0.5 ċm sa 1.5 ċm sa 0.5 mL
English: Plasmacytoma at injection site* Blood and lymphatic system disorders Very common Oedema peripheral Common
Maltese: Plażmaċitoma fis-sit tal-injezzjoni* Disturbi tad-demm u tas-sistema limfatika Komuni ħafna Oedema periferali
English: • Confusion, anxiety, depression, dizziness, difficulty sleeping (insomnia)
Maltese: • Konfużjoni, ansjetà, dipressjoni, sturdament, diffikultà fl-irqad (insomnija)
English: Not reached (Range: > 0.0 to > 16.8 months)
Maltese: Mhux milħuq (Firxa: > 0.0 to > 16.8 xhur)
English: Talimogene laherparepvec is produced in Vero cells by recombinant DNA technology.
Maltese: Talimogene laherparepvec hu prodott f'ċelloli Vero cells b'teknoloġija rikombinanti tad-DNA.
English: Number of Subjects at Risk:
Maltese: Numru ta 'individwi f'Riskju:
English: The most commonly reported adverse reactions (≥ 25%) in Imlygic-treated patients were fatigue (50.3%), chills (48.6%), pyrexia (42.8%), nausea (35.6%), influenza-like illness (30.5%), and injection site pain (27.7%).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati (≥ 25%) fil-pazjenti ttrattati b'Imlygic kienu l-għeja (50.3%), sirdat (48.6%), deni (42.8%), dardir (35.
English: Metabolism and nutrition disorders Common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: Plasmacytoma
Maltese: Plażmaċitoma
English: Talimogene laherparepvec is an oncolytic immunotherapy that is derived from HSV-1.
Maltese: Talimogene laherparepvec hu immunoterapija onkolitika li tiġi minn HSV-1.
English: • Thaw Imlygic vial(s) at room temperature.
Maltese: • Ħoll il-kunjett(i) ta' Imlygic f'temperatura ambjentali tal-kamra.
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.5% tal-konsum fid-dieta massimu rrakkomandat ta' kuljum ta' sodju għal persuna adulta.
English: Figure 3.
Maltese: Stampa 3.
English: 90% of patients treated with Imlygic experienced influenza-like symptoms.
Maltese: 90% tal-pazjenti ttrattati b'Imlygic esperjenzaw sintomi li jixbhu l-influwenza.
English: Vascular disorders Common
Maltese: Disturbi vaskulari Komuni
English: Across studies, fatal disseminated viral infection was observed in 14% of nude mice following treatment with talimogene laherparepvec at doses that are 10 to 100-fold higher than those that result in 100% lethality with wild-type HSV-1.
Maltese: Fl-istudji, kien osservat it-tixrid ta' infezzjoni virali fatali f'14% tal-ġrieden nudi wara t-trattament b'talimogene laherparepvec f'dożi li huma minn 10 sa 100 darba aktar minn dawk li jwasslu għal 100% letalità b'HSV-1 tat-tip selvaġġ.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI RESPONSABBLI
English: Sixty patients with melanoma received Imlygic intralesional injection at a dose and schedule same as clinical study 005/05 (see section 5.1).
Maltese: Sittin pazjent b'melanoma rċevew injezzjoni ġol-ferita ta' Imlygic fl-istess doża u skeda bħall-Istudju kliniku 005/05 (ara sezzjoni 5.1).
English: The safety of Imlygic was evaluated in the pivotal study where 292 patients received at least 1 dose of Imlygic (see section 5.1).
Maltese: Is-sigurtà ta' Imlygic ġiet evalwata fl-istudju importanti fejn 292 pazjenti rċevew mill-inqas doża 1 ta' Imlygic (ara sezzjoni 5.1).
English: Figure 6.
Maltese: Stampa 6.
English: Hepatic and renal impairment
Maltese: Indeboliment epatiku u renali
English: Do not exceed the storage times specified in table 1 and table 2.
Maltese: Taqbiżx ilħinijiet tal-ħażna speċifikati f'tabella 1 u tabella 2.
English: Tumour pain, Infected neoplasm
Maltese: Uġigħ fit-tumur, Neoplażma infettata
English: 26.4% (n = 78) (95% CI: 21.4%, 31.5%) (10.8% CR, 15.6% PR)
Maltese: 26.4% (n = 78) (95% CI: 21.4%, 31.5%) (10.
English: Figure 4.
Maltese: Stampa 4.
English: Herpes infection
Maltese: Infezzjoni erpetika
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L01XX51.
Maltese: Sustanzi antineoplastiċi u immunomodulanti, Kodiċi ATC:
English: > 1.5 cm to 2.5 cm up to 1 mL
Maltese: > 1.5 ċm sa 2.5 ċm sa 1 mL
English: This medicinal product contains approximately 30 mg sodium per 4 mL dose, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih madwar 30 mg sodju kull 4 mL doża, ekwivalenti għal 1.5% tal-konsum massimu rakkomandat ta' kuljum tal-WHO ta' 2 g ta' sodju għal persuna adulta.
English: GRH0116v1
Maltese: GRH0252MTv1
English: OS (hazard ratio) Imlygic GM-CSF Imlygic GM-CSF Imlygic vs GM-CSF
Maltese: Kif tiddetermina l-volum tad-dożaġġ ta' Imlygic (għal kull ferita)
English: Imlygic is a clear to semi-translucent (106 PFU/mL) or semi-translucent to opaque (108 PFU/mL) liquid.
Maltese: Imlygic hu likwidu ċar għal semitrasluċidu (106 PFU/mL) jew likwidu semitrasluċidu għal opak (108 PFU/mL).
English: Summary of results for the ITT population from Imlygic study 005/05 Study endpoint
Maltese: Sommarju tar-riżultati għall-popolazzjoni ITT mill-istudju 005/05 ta' Imlygic
English: The active ingredient of Imlygic is talimogene laherparepvec.
Maltese: Is-sustanza attiva ta' Imlygic hi talimogene laherparepvec.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mL of 1 x 108 (100 million) plaque forming units (PFU) of talimogene laherparepvec.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kunjett fih 1 mL of 1 x 108 (100 miljun) unità li tifforma plakka (PFU) ta' talimogene laherparepvec.
English: The secondary endpoints included overall survival (OS), overall response rate (ORR) [PR+CR], time to response, duration of response, and time to treatment failure (time from randomisation until the first episode of clinically relevant disease progression where there is no response achieved after the progression event, or until death).
Maltese: Il-punti tat-tmiem sekondarji inkludew sopravivenza globali (Overall Survival, OS), rata ta' rispons globali (Overall Response Rate, ORR) [PR+CR], żmien għar-rispons, tul ta' żmien tar-rispons, u żmien għall-falliment tal-kura (ħin mill-għażla każwali sal-ewwel episodju ta' progressjoni fil-mard relevanti klinikament fejn ma jinkisibx rispons wara l-avveniment tal-progressjoni jew sal-mewt).
English: The most common grade 3 or higher adverse reaction was cellulitis (2.1%) (see section 4.4).
Maltese: L-aktar reazzjoni avversa komuni ta' grad 3 jew ogħla kienet iċ-ċellulite (2.1%) (ara sezzjoni 4.4).
English: > 2.5 cm to 5 cm up to 2 mL
Maltese: > 2.5 ċm sa 5 ċm sa 2 mL
English: Gastrointestinal disorders
Maltese: Espożizzjoni aċċidentali
English: • Cough
Maltese: Xhur
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mL of 1 x 106 (1 million) plaque forming units (PFU) of talimogene laherparepvec.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kunjett fih 1 mL ta' 1 x 106 (1 miljun) unità li tifforma plakka (PFU) ta' talimogene laherparepvec.
English: Deep vein thrombosis, Hypertension, Flushing Respiratory, thoracic and mediastinal disorders Very common Cough Common
Maltese: Trombożi fil-vini profondi, Pressjoni għolja, Ħmura Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna Sogħla Komuni
English: • Before use, thaw frozen Imlygic vials at room temperature (20ºC to 25ºC) until Imlygic is liquid (approximately 30 minutes).
Maltese: • Qabel tużahom, ħoll il-kunjetti ffriżati b'Imlygic f'temperatura ambjentali tal-kamra (20°C to 25°C) sakemm Imlygic isir likwidu (għal madwar 30 minuta).
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti moniteraġġ kontinwu tal-bilanċ tal-benefiċċji/riskji tal-prodott mediċinali.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta tal-eċċipjenti, ara sezzjoni 6.1.
English: OR Figure 7.
Maltese: JEW Stampa 7.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC
English: • 108 (100 million) PFU/mL - For all subsequent doses.
Maltese: • 108 (100 miljun) PFU/mL - Għad-dożi sussegwenti kollha.
English: (listed in section 6).
Maltese: (ara sezzjoni 5.1).
English: Number of Patients at Risk
Maltese: Numru ta 'pazjenti f'riskju
English: Median [95% CI] 23.3 [19.5, 29.6] months Median [95% CI] 18.9 [16.0, 23.7] months
Maltese: Medjan [95% CI] 23.3 [19.5, 29.6] xhur Medjan [95% CI] 18.
English: Talimogene laherparepvec is an attenuated herpes simplex virus type-1 (HSV-1) derived by functional deletion of 2 genes (ICP34.5 and ICP47) and insertion of coding sequence for human granulocyte macrophage colony-stimulating factor (GM-CSF) (see section 5.1).
Maltese: Talimogene laherparepvec hu virus herpes simplex mitigat ta' tip-1 (herpes simplex virus, HSV-1) derivat mit-tneħħija funzjonali ta' 2 ġeni (ICP34.5
English: No effects on embryo-foetal development were observed when talimogene laherparepvec was administered during organogenesis to pregnant mice at doses up to 4 x 108 (400 million) PFU/kg (60-fold higher, on a PFU/kg basis, compared to the maximum clinical dose).
Maltese: Ma kinux osservati effetti fuq l-iżvilupp tal-fetu fl-istadju embrijoniku meta talimogene laherparepvec kien mogħti waqt l-organoġenesi lil ġrieden tqal f'dożi sa 4 x 108 (400 miljun) PFU/kg (60 darba aktar, fuq bażi ta' PFU/kg, imqabbla mad-doża klinika massima).
English: Negligible amounts (< 0.001% of maternal blood levels) of talimogene laherparepvec DNA were found in foetal blood.
Maltese: Ammonti negliġibbli (< 0.001% ta' livelli ta' demm maternali) ta' DNA ta' talimogene laherparepvec instabu fid-demm talfetu.
English: • Trained HCPs to record batch number information in patient´s charts and on the patient´s alert card for all injections and to provide the batch number when reporting adverse drug reactions.
Maltese: • HCPs imħarrġa biex jirreġistraw informazzjoni dwar in-numru tal-lott fiċ-charts u fuq il-kard ta' allert tal-pazjent għall-injezzjonijiet kollha, u biex jiġi pprovdu n-numru tal-lott meta jiġu rrappurtati reazzjonijiet avversi tal-mediċina.
English: Nervous system disorders Very common Headache Common
Maltese: Disturbi fis-sistema nervuża Komuni ħafna Uġigħ ta' ras Komuni
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Maltese: (≥ 1/1,000 to < 1/100).
English: Traceability of Imlygic
Maltese: Traċċabilità ta' Imlygic
English: • Infection caused by bacteria (cellulitis), cold sores (oral herpes)
Maltese: • Infezzjoni kkawżata mill-batterja (ċellulite), ponot (erpete orali)
English: Name and address of the manufacturers responsible for batch release Amgen Europe B.V.
Maltese: Isem u indirizz tal-manifatturi responsabbli għall-ħruġ tal-lott Amgen Europe B.V.
English: Because wild-type HSV-1 does not integrate into the host genome, the risk of insertional mutagenesis with talimogene laherparepvec is negligible.
Maltese: Minħabba li HSV-1 tat-tip selvaġġ ma jintegrax fil-ġenoma ospitanti, ir-riskju ta' mutaġenesi inserzjonali b'talimogene laherparepvec hi negliġibbli.
English: • Patients who are severely immunocompromised (e.g. patients with severe congenital or acquired cellular and/or humoral immune deficiency) (see section 4.4).
Maltese: • Pazjenti li huma immunokompromessi b'mod sever (eż. pazjenti b'defiċjenza immuni ċellulari u/jew umorali konġenitali severa jew miksuba) (ara sezzjoni 4.4).
English: After 6 months of treatment, patients were to continue treatment until clinically relevant disease progression (i.e. disease progression associated with a decline in performance status and/or alternative therapy was required in the opinion of the investigator).
Maltese: Wara 6 xhur ta' trattament, il-pazjenti kellhom ikomplu t-trattament sakemm seħħet progressjoni tal-marda klinikament rilevanti (i.e. progressjoni tal-marda assoċjata ma' tnaqqis fl-istat ta' prestazzjoni u/jew terapija alternattiva kienet meħtieġa fl-opinjoni tal-investigatur).
English: • Areas of skin without any colour (vitiligo), rash, inflamed skin (dermatitis)
Maltese: • Partijiet fil-ġilda bla kulur (vitiligo), raxx, ħruq fil-ġilda (dermatite)
English: Marketing Authorisation Holder Amgen Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Amgen Europe B.V.
English: Exploratory subgroup analyses for DRR and overall survival by stage of disease were also carried out (see figure 5 and table 5).
Maltese: Saret ukoll analiżi esploratorja tas-sottogruppi għad-DRR u s-sopravivenza globali bl-istadju tal-marda (ara figura 5 u tabella 5).
English: The difference in DRR between Imlygic and GM-CSF in the ITT population was statistically significant (see table 4) in favour of Imlygic.
Maltese: Id-differenza f'DRR bejn Imlygic u GM-CSF fil-popolazzjoni ITT kienet statistikament sinifikanti (ara tabella 4) favur Imlygic.
English: Accidental exposure to Imlygic
Maltese: Mediċina oħra u Imlygic
English: B. PACKAGE LEAFLET
Maltese: Pazjenti b'DNA osservabbli matul it-trattament
English: • Apply pressure to the injection site with a sterile gauze for at least 30 seconds.
Maltese: • Ippressa l-punt tal-inseriment b'garża sterili għal mill-inqas 30 sekonda.
English: Incidence of adverse reactions are presented by system organ class and by frequency.
Maltese: L-inċidenza tarreazzjonijiet avversi hija ppreżentata skont is-sistema tal-klassifika tal-organi u skont il-frekwenza.
English: Dispose of all materials that have come in contact with Imlygic (e.g. vial, syringe, needle, any cotton or gauze) in accordance with local institutional procedures (see section 6.6).
Maltese: Armi l-materjal kollu li jkun intmess ma' Imlygic (eż. il-kunjett, is-siringa, il-labra, kwalunkwe tajjar jew garża) skont il-proċeduri istituzzjonali lokali (ara sezzjoni 6.6).
English: It is supplied as a 1 mL preservative free solution in a single -use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene).
Maltese: Hu pprovdut f'soluzzjoni ta' 1 mL mingħajr preservattivi f'kunjett li jintuża darba (cyclic olefin polymer plastic resin) b'tapp (chlorobutyl elastomer) u siġill (aluminium) b'għatu li jinfetaħ b'daqqa ta' saba' (polypropylene).
English: In the 60 patients treated, data indicate that talimogene laherparepvec DNA was present in all sites during the study (see table 6).
Maltese: Fis-60 pazjent li ġew ittrattati, id-data tindika li d-DNA ta' talimogene laherparepvec kien preżenti fis-siti kollha matul l-istudju (ara t-tabella 6).
English: The biodistribution and shedding of intralesionally administered talimogene laherparepvec were investigated in a clinical study that measured talimogene laherparepvec DNA in blood, urine, injection site, exterior of the occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.
Maltese: Il-bijodistribuzzjoni u t-tixrid ta' talimogene laherparepvec mogħti minn ġol-feriti ġew investigati fi studju kliniku li kejjel id-DNA ta' talimogene laherparepvec fid-demm, fl-awrina, fis-sit tal-injezzjoni, minn barra l-infaxxaturi okklussivi, fil-mukuża tal-ħalq, fl-erja anoġenitali, u f'leżjonijiet erpetiċi ssuspettati.
English: SPECIAL STORAGE CONDITIONS Store and transport frozen at -90° to -70°C.
Maltese: Aħżen u ttrasporta fil-friża f'temperatura ta' -90° sa -70°C.
English: Biodistribution (within the body) and viral shedding (excretion/secretion)
Maltese: Bijodistribuzzjoni (fi ħdan il-ġisem) u tixrid virali (eskrezzjoni/sekrezzjoni)
English: The MAH shall ensure that in each Member State where IMLYGIC is marketed, a system aimed to control distribution to IMLYGIC beyond the level of control ensured by routine risk minimisation measures.
Maltese: L-MAH għandu jiżgura li f'kull Stat Membru fejn IMLYGIC jitpoġġa fis-suq, ikun hemm sistema maħsuba biex tikkontrolla d-distribuzzjoni ta' IMLYGIC lil hinn mil-livell ta' kontroll żgurat permezz ta' miżuri ta' rutina tal-minimizzazzjoni tar-riskju.
English: The modifications to talimogene laherparepvec from HSV-1 include deletion of ICP34.5 and ICP47.
Maltese: Il-modifiki ta' talimogene laherparepvec minn HSV-1 jinkludu t-tħassir ta' ICP34.5
English: This medicine contains 80 mg sorbitol in each 4 mL dose.
Maltese: Din il-mediċna fiha 80 mg sorbitol f'kull doża ta' 4 mL.
English: 1 week (7 days)
Maltese: Ġimgħa (7 ġurnata)
English: The following side effects have been reported in patients receiving Imlygic:
Maltese: L-effetti sekondarji li ġejjin ġew irrappurtati fil-pazjenti li jirċievu Imlygic:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1064/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1064/001
English: Initial
Maltese: Inizjali
English: • Herpetic infection occurring throughout the entire body (disseminated herpetic infection) in immunocompromised individuals (those with any congenital or acquired cellular and/or humoral immune deficiency, i.e. HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or those who require high-dose steroids or other immunosuppressive agents)
Maltese: • Infezzjoni erpetika sseħħ madwar il-ġisem kollu (infezzjoni erpetika mifruxa) f'individwi immunokompromessi (dawk bi kwalunkwe defiċjenza ċellulari konġenitali jew miksuba u/jew defiċjenza immunitarja umorali, i.e. HIV/AIDS, lewkimja, limfoma, immunodefiċjenza varjabbli komuni, jew dawk li jkunu jeħtieġu doża għolja ta' sterojdi jew mediċini immunosoppressivi oħrajn)
English: † Immune mediated events include: uncommon terms of vasculitis, pneumonitis, worsening psoriasis and glomerulonephritis.
Maltese: L-avvenimenti medjati mis-sistema immunitarja jinkludu: termini mhux komuni ta' vaskulite, pnewmonite, psorjażi aggravata u glomerulonefrite.
English: Talimogene laherparepvec is degraded by typical endogenous protein
Maltese: Talimogene laherparepvec jiġi degradat bi proteina endoġena tipika u bilpassaġġi kataboliċi tad-DNA.
English: • Patient information pack
Maltese: INFORMAZZJONI BIL-BRAILLE
English: In clinical studies, immune-mediated events including as glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with Imlygic.
Maltese: Fi studji kliniċi, ġew irrappurtati avvenimenti medjati mis-sistema immunitarja li jinkludu glomerulonefrite, vaskulite, pnewmonite, psorjażi aggravata, u vitiligo f'pazjenti ttrattati b'Imlygic.
English: Confusional state, Anxiety, Depression, Dizziness, Insomnia
Maltese: Stat ta' konfużjoni, Ansjetà, Dipressjoni, Sturdament, Insomnija Disturbi fl-għajnejn
English: Malaise, Axillary pain
Maltese: Popolazzjoni pedjatrika
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1064/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1064/002
English: • 106 (1 million) PFU/mL - For initial dose only.
Maltese: • 106 (1 miljun) PFU/mL - Għal doża inizjali biss.
English: Cardiac disorders Common
Maltese: Disturbi kardjiaċi Komuni
English: Imlygic was administered by intralesional injection at an initial concentration of 106 (1 million) PFU/mL on day 1, followed by a concentration of 108 (100 million) PFU/mL on day 21 and every 2 weeks thereafter at a dose of up to 4 mL.
Maltese: Imlygic ingħata permezz ta' injezzjoni fil-ferita f'konċentrazzjoni inizjali ta' 106 (1 miljun) PFU/mL fl-ewwel jum, u f'konċentrazzjoni ta' 108 (100 miljun) PFU/mL fil-21 jum u mbagħad kull ġimagħtejn f'doża sa 4 mL.
English: 24 hours
Maltese: 24 siegħa
English: Symptoms of a local or systemic infection possibly related to Imlygic are anticipated to be similar to symptoms caused by wild-type HSV-1 infections.
Maltese: Is-sintomi ta' infezzjoni lokali jew sistemika possibbilment relatati ma' Imlygic huma antiċipati li huma simili għas-sintomi kkawżati bl-infezzjonijiet tat-tip selvaġġ ta' HSV-1.
English: Infections and infestations Common
Maltese: Infezzjonijiet u infestazzjonijiet Komuni
English: Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1).
Maltese: Imlygic hu indikat għat-trattament ta' adulti b'melanoma li ma tistax titneħħa li hi reġjonalment jew distintivament metastatika (Stadju IIIB, IIIC u IVM1a) mingħajr mard fl-għadam, fil-moħħ, filpulmun jew mard ieħor vixxerali (ara sezzjonijiet 4.4 u 5.1).
English: 6.4 Special precautions for storage Store and transport frozen (-90°C to -70°C).
Maltese: Aħżen u ttrasporta fil-friża f'temperatura ta' (-90°C sa -70°C).
English: Deletion of ICP47 prevents downregulation of antigen presentation molecules and increases the expression of HSV US11 gene, thereby enhancing viral replication in tumour cells.
Maltese: It-tħassir ta' ICP47 jippreveni ttnaqqis ta' molekuli bi preżentazzjoni antiġena u jżid l-espressjoni tal-ġene HSV US11, u b'hekk isaħħaħ ir-replikazzjoni virali fiċ-ċelloli tat-tumur.
English: Carcinogenicity
Maltese: Karċinoġeniċità
English: • Flu-like illness, fever (pyrexia), chills, fatigue, pain
Maltese: • Mard bħall-influwenza, deni (piressija), sirdat, għeja, uġigħ
English: Body fluid/site
Maltese: Fluwidu/sit tal-ġisem
English: The primary endpoint was durable response rate (DRR) [defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of 6 months] per blinded central review.
Maltese: Il-punt tat-tmiem primarju kien rata ta' rispons durabbli (durable response rate, DRR) [imfissra bħala l-perċentwal ta' pazjenti b'rispons komplut (Complete Response, CR) jew b'rispons parzjali (Partial Response, PR) miżmum kontinwament għal minimu ta' 6 xhur] kull blinded central review.
English: • Adequately trained and experienced HCPs in order to minimise the risk of occurrence of specified adverse drug reactions in patients, HCPs, and close contacts of the patients;
Maltese: • HCPs li jkunu mħarrġa b'mod adegwat u b'esperjenza sabiex jiġi mminimizzat ir-riskju ta' okkorrenza ta' reazzjonijiet avversi tal-mediċina speċifikati fil-pazjenti, HCPs, u kuntatti millqrib tal-pazjenti;
English: Imlygic is provided as a one ml preservative-free solution in a single-use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene) in two different presentations:
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Imlygic huwa pprovdut bħala soluzzjoni ta' milliltru (1 mL) mingħajr preservattivi f'kunjett li jintuża darba (cyclic olefin polymer plastic resin) b'tapp (chlorobutyl elastomer) u siġill (aluminium) b'għatu li jinfetaħ b'daqqa ta' saba' (polypropylene) f'żewġ preżentazzjonijiet differenti:
English: The initial recommended dose is up to a maximum of 4 mL of Imlygic at a concentration of 106 (1 million) PFU/mL.
Maltese: Iddoża inizjali rakkomandata hi sa massimu ta' 4 mL ta' Imlygic f'konċentrazzjoni ta' 106 (1 miljun) PFU/mL.
English: Patients with active brain metastases, bone metastases, extensive visceral disease, primary ocular or mucosal melanoma, evidence of immunosuppression, or receiving treatment with a systemic anti-herpetic agent were excluded from the study.
Maltese: Pazjenti b'metastasi attiva fil-moħħ, b'metastasi fl-għadam, b'mard estensiv fil-vixxri, b'melanoma okulari primarja jew mukożali, b'evidenza ta' immunosuppressjoni, jew li qed jingħataw it-trattament b'sustanza sistemika antierpetika ġew esklużi mill-istudju.
English: Immune system disorders Common
Maltese: Disturbi fis-sistema immunitarja Komuni
English: Musculoskeletal and connective tissue disorders Very common Myalgia, Arthralgia, Pain in extremity Common
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi Komuni ħafna Majalġja, Artralġja, Uġigħ fl-estremitajiet Komuni
English: NAME OF THE MEDICINAL PRODUCT Imlygic 106 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Maltese: Imlygic 106 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni talimogene laherparepvec
English: Immune-mediated events
Maltese: Avvenimenti medjati mis-sistema immunitarja