FrancophonIA/ELRC3.0 huggingface dataset:
English: With regards to the effects on the ability to drive and use machines, the PRAC recommended that vehicle drivers and machine operators are warned that in addition to the possible risk of drowsiness, prolonged reaction time and impaired driving the morning after therapy, there is also the possibility of dizziness, sleepiness, blurred/double vision and reduced alertness.
Maltese: Fir-rigward tal-effetti fuq il-ħila ta' sewqan u użu ta' makkinarji, il-PRAC irrakkomanda li s-sewwieqa ta' vetturi u operaturi ta' makkinarji jitwissew li minbarra r-riskju possibbli li wieħed iħoss telqa, ħin itwal ta' reazzjoni u sewqan imxekkel l-għada filgħodu tat-terapija, hemm anki l-possibbiltà ta' dardir, ngħas, vista mċarpja/li wieħed jara doppju u prontezza mtaffija.
English: The analysis of the submitted individual case reports of driving ability and somnambulism showed that whatever the age and gender category, most of the cases of impaired driving were reported at a 10mg daily dose for both events.
Maltese: L-analiżi tar-rapporti ta' każijiet individwali sottomessi dwar il-ħila ta' sewqan u sonnambuliżmu wrew li tkun xi tkun il-kategorija tal-età u s-sess, ħafna mill-każijiet ta' sewqan imxekkel ġew irrapportati b'doża ta' 10mg kuljum għaż-żewġ avvenimenti.
English: In light of the data provided in the cumulative review performed by the MAH, and taking into consideration the recent Food and Drug Administration (FDA) approved label changes specifying new dosing recommendations for zolpidem-containing medicinal products, AIFA considered that it was in the interest of the EU to refer the matter to the PRAC for a benefit-risk review of zolpidem-containing medicinal products.
Maltese: Fid-dawl tad-dejta pprovduta fl-analiżi kumulattiva mwettqa mill-MAH, u wara li ġew ikkunsidrati lbidliet riċenti fit-tikketti tal-Amministrazzjoni għall-Ikel u għall-Mediċinali (Food and Drug Administration (FDA)) li jispeċifikaw rakkomandazzjonijiet ġodda ta' dożaġġ għal prodotti mediċinali li fihom zolpidem, l-AIFA qieset li kien fl-interess tal-UE li tirreferi l-kwistjoni lill-PRAC biex jagħmel analiżi talbenefiċċji/riskji ta' prodotti mediċinali li fihom zolpidem.
English: Overall summary of the scientific evaluation by PRAC
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika mill-PRAC
English: • The PRAC reviewed all available data provided by the MAHs on the safety and efficacy of zolpidemcontaining medicines with regards the risk of impaired driving ability and somnambulism following treatment with zolpidem;
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli pprovduta mill-MAHs dwar is-sikurezza u l-effikaċja ta' mediċini li fihom zolpidem fir-rigward tar-riskju ta' ħila mnaqqsa ta' sewqan u sonnambuliżmu wara kura b'zolpidem;
English: • The PRAC considered that the data from post-marketing spontaneous case reports, clinical trials, published literature and other available information have shown that the use of zolpidemcontaining products is associated with an increased risk of impaired driving and somnambulism;
Maltese: • Il-PRAC qies li d-dejta minn rapporti ta' każijiet spontanji ta' wara t-tqegħid fis-suq, provi kliniċi, tagħrif ippubblikat u informazzjoni oħra disponibbli wriet li l-użu ta' prodotti li fihom zolpidem huwa assoċjat ma' riskju miżjud ta' sewqan imxekkel u sonnambuliżmu;
English: It was however acknowledged that in some patients a lower dose of 5mg could be effective.
Maltese: Madakollu, ġie rikonoxxut li f'ċerti pazjenti, doża inqas ta' 5mg tista' tkun effettiva.
English: Amongst the risk factors for impaired driving and somnambulism were, concomitant intake of other CNS depressants, sleep-deprivation and alcohol or illicit drugs consumption.
Maltese: Fuq il-bażi ta' evidenza mit-tagħrif, tqies li hemm bżonn li tiġi emendata u armonizzata s-sezzjoni ‘Interazzjoni ma' prodotti mediċinali oħrajn' tal-informazzjoni dwar il-prodott.
English: The PRAC reviewed the safety and efficacy data relating to the risk of impaired driving and somnambulism following treatment with zolpidem.
Maltese: Il-PRAC analizza d-dejta dwar is-sikurezza u l-effikaċja relatati mar-riskju ta' sewqan imxekkel u sonnambuliżmu wara kura b'zolpidem.
English: Range (mmol/L)
Maltese: Medda (mmol/L)
English: Date of first authorisation: 20 November 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Novembru 2018
English: Standard dose:
Maltese: Doża standard:
English: Angina pectoris, tachycardia
Maltese: Angina pectoris, takikardija
English: Frequency Preferred term
Maltese: Frekwenza Terminu Ppreferut
English: Number at risk
Maltese: Numru f'riskju
English: Overall Paclitaxel Carboplatin Overall Paclitaxel Carboplatin
Maltese: Globali Paclitaxel Carboplatin Globali Paclitaxel Carboplatin
English: Very common: Anorexia
Maltese: Komuni ħafna: Anoressija
English: The recommended dose of carboplatin is AUC = 5-6 mg/mL×min.
Maltese: Id-doża rakkomandata ta' carboplatin hija AUC = 5-6 mg/mL×min.
English: • The active substance is paclitaxel.
Maltese: • Is-sustanza attiva hi paclitaxel.
English: Each vial contains 3.77 mg (0.164 mmol) sodium.
Maltese: Kull kunjett fih 3.77 mg (0.164 mmol) sodium.
English: Apealea dose for subsequent courses (mg/m2)b
Maltese: Doża ta' Apealea għal korsijiet sussegwenti (mg/m2)b
English: 752 28 Uppsala Sweden
Maltese: 752 28 Uppsala
English: Oasmia Pharmaceutical AB Uppsala, Sweden
Maltese: Oasmia Pharmaceutical AB Uppsala, l-Iżvezja
English: Number of deaths, n (%)
Maltese: Numru ta' mwiet, n (%)
English: non-inferiority margin (1.185)
Maltese: marġini ta' nuqqas ta' inferjorità (1.185)
English: SE-752 28 Uppsala Sweden
Maltese: SE-752 28 Uppsala
English: • toxicity to the nervous system
Maltese: • tossiċità għas-sistema nervuża
English: Alopecia was observed in 45% of patients and was abrupt in onset.
Maltese: Alopeċja ġiet osservata f'45 % tal-pazjenti u kienet f'daqqa fil-bidu.
English: Possible dose reductions:
Maltese: Tnaqqis possibbli fid-doża:
English: − fever
Maltese: − fsada
English: Paclitaxel has been shown in vitro to be a substrate for the influx transporter proteins OATP1B3 and OATP1A2.
Maltese: Paclitaxel intwera in vitro li huwa substrat għall-proteini tat-trasportatur tal-influss OATP1B3 u OATP1A2.
English: Clinically relevant pharmacokinetic interaction has been observed between paclitaxel and cisplatin.
Maltese: Ġiet osservata interazzjoni farmakokinetika klinikament rilevanti bejn paclitaxel u cisplatin.
English: The corresponding median number of cycles (min;max) for the two groups were 6 (1;12) and 6 (1;9), respectively.
Maltese: In-numru medjan korrispondenti ta' ċikli (min;mass) għaż-żewġ gruppi kien 6 (1;12) u 6 (1;9), rispettivament.
English: Based on the combined data from monotherapy studies, very common adverse reactions and those of special interest were the following: neutropenia (45%), fatigue (37%), leukopenia (33%), alopecia (30%), nausea (27%), infusion site reactiona (23%), peripheral sensory neuropathy (20%), diarrhoea (17%), asthenia (15%), pyrexia (12%), constipation (12%), arthralgia (12%), paraesthesia (11%), pain (11%), vomiting (9%), myalgia (9%), peripheral motor neuropathy (5%), neuropathy (5%), neuropathy peripheral (5%), thrombocytopenia (4%), febrile neutropenia (2%), sepsis (2%), tachycardia (2%), phlebitis (2%), thrombosis (2%).
Maltese: nawsja (27 %), reazzjoni fis-sit tal-infużjonia (23 %), newropatija sensorja periferika (20 %), dijarea (17 %), astenija (15 %), deni (12 %), stitikezza (12 %), artralġja (12 %), paresteżija (11 %), uġigħ (11 %), rimettar (9 %), mijalġija (9 %), newropatija motorika periferika (5 %), newropatija (5 %), newropatija periferika (5 %), tromboċitopenja (4 %), newtropenija bid-deni (2 %), sepsis (2 %), takikardija (2 %), flebite (2 %), trombożi (2 %).
English: The pharmacokinetics of paclitaxel were studied in 22 patients with solid tumours after 1-hour infusions of Apealea (dose levels of 90 to 275 mg/m2).
Maltese: Il-farmakokinetika ta' paclitaxel ġiet studjata fi 22 pazjent b'tumuri solidi wara infużjonijiet ta' siegħa ta' Apealea (livelli tad-doża ta' 90 sa 275 mg/m2).
English: • herpes simplex (a viral infection), viral airways infections
Maltese: • herpes simplex (infezzjoni virali), infezzjonijiet virali fil-passaġġi tal-arja
English: This is equivalent to 80% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 80% tat-teħid ta' sodium fid-dieta massimu rakkomandat kuljum għal adult.
English: The mean age was 56 years of age in both treatment groups (range 26-81).
Maltese: L-età medja kienet 56 sena fiż-żewġ gruppi ta' trattament (medda 26-81).
English: Mutagenesis, carcinogenesis, impairment of fertility
Maltese: Mutaġeneżi, karċinoġeneżi, indeboliment tal-fertilità
English: There was no marked difference in overall tolerability between the 65-74 age group and younger patients.
Maltese: Ma kien hemm l-ebda differenza sinifikanti fit-tollerabbiltà globali bejn il-grupp ta' età ta' 65-74 sena u pazjenti iżgħar.
English: Very common: Neutropeniaa Common:
Maltese: Komuni ħafna: Newtropenijaa Komuni:
English: Pharmacokinetic data for patients with total bilirubin > 5 × ULN are not available.
Maltese: M'hemmx data farmakokinetika disponibbli għal pazjenti b'bilirubina totali > 5 × ULN.
English: The mean unbound fraction of paclitaxel (fu) varied between 5.2% and 4.3% over time after Apealea infusion.
Maltese: Il-frazzjoni mhux marbuta medja ta' paclitaxel (fu) varjat bejn 5.2 % u 4.3 % maż-żmien wara l-infużjoni ta' Apealea.
English: Very common: Alopeciaa Common:
Maltese: Komuni ħafna: Alopeċjaa Komuni:
English: − breathing difficulties
Maltese: Disturbi respiratorji,
English: Paclitaxel (solvent-based)
Maltese: Paclitaxel (ibbażat fuq solvent)
English: A similar effect can be anticipated for Apealea (paclitaxel micellar).
Maltese: Effett simili jista' jiġi antiċipat għal Apealea (paclitaxel miċellari).
English: favours Apealea favours solvent-based paclitaxel
Maltese: It-Tieni favur Apealea favur paclitaxel ibbażat fuq solvent
English: Musculoskeletal and connective tissue disorders Arthralgia occurred in 19% of patients and myalgia in 10%.
Maltese: Disturbi muskoloskeletali u tat-tessuti konnettivi Artralġja seħħet fi 19 % tal-pazjenti u mijalġija f'10 %.
English: Cardiotoxicity
Maltese: Kardjotossiċità
English: PFS as the primary endpoint was evaluated by blinded assessment of computerised tomography images using Response Evaluation Criteria in Solid Tumours (RECIST) 1.0.
Maltese: (OS). Il-PFS bħala l-punt finali primarju ġiet evalwata permezz ta' valutazzjoni blinded ta' immaġni ta' tomografija kompjuterizzati permezz tal-Kriterji ta' Evalwazzjoni ta' Rispons f'Tumuri Solidi (RECIST) 1.0.
English: Patients 65 years and older
Maltese: Pazjenti ta' 65 sena u aktar
English: Kaplan-Meier curve of OS (PP population)
Maltese: Kurva ta' Kaplan-Meier ta' OS (popolazzjoni PP)
English: • clopidogrel: a medicine that reduces the chances of getting blood clots
Maltese: • clopidogrel: mediċina li tnaqqas il-probabbiltà li jkollok koagulazzjoni tad-demm
English: Palmar-plantar erythrodysesthesia syndromec
Maltese: Sindrome ta' ertrodisestezija palmar-plantarc
English: The model indicated that a 0.2 m2 increase in BSA would lead to a 9% increase in the elimination rate.
Maltese: 0.2 m2 fil-BSA twassal għal żieda ta' 9 % fir-rata ta' eliminazzjoni.
English: Figure 4.
Maltese: Figura 4.
English: H2 antagonists
Maltese: Kortikosterojdi Antistamini Antagonisti ta' H2
English: The frequency of undesirable effects listed in Table 2 is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa elenkati f'Tabella 2 hija definita skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari
English: Only a few patients had ECOG performance status of 2.
Maltese: Ftit pazjenti biss kellhom status tal-prestazzjoni ECOG ta' 2.
English: In the intention-to-treat (ITT) population (n = 789), the hazard ratios for PFS and OS were 0.85 (95% CI: 0.72;1.00) and 1.02 (95% CI: 0.85;1.22), respectively.
Maltese: (n = 789), il-proporzjonijiet ta' periklu għal PFS u OS kienu 0.85 (95 % CI: 0.72;1.00) u 1.02 (95 % CI: 0.85;1.22), rispettivament.
English: Nervous system disorders grade ≥ 2 peripheral sensory neuropathy or grade ≥ 2 motor neuropathy
Maltese: Disturbi fis-sistema nervuża newropatija sensorja periferika ta' grad ≥ 2
English: Infusion site reactions, such as pain, phlebitis, and erythema, were seen in 12% of patients (see section 4.4).
Maltese: Reazzjonijiet fis-sit tal-infużjoni, bħal uġigħ, flebite, u eritema kienu osservati fi 12% tal-pazjenti (ara sezzjoni 4.4).
English: n Events
Maltese: Pazjenti Avvenimenti
English: Neutropenia occurred in 79% and 66%, leukopenia in 53% and 34%, thrombocytopenia in 18% and 10%, and anaemia in 24% and 14% of the patients in the treatment arms receiving either paclitaxel micellar or solvent-based paclitaxel, respectively.
Maltese: Newtropenija seħħet f'79 % u 66 %, lewkopenija fi 53 % u 34 %, tromboċitopenja fi 18 % u 10 %, u anemija f'24 % u
English: Nausea (38%), vomiting (22%) and diarrhoea (15%) were among the most commonly reported adverse reactions in the study.
Maltese: Nawsja (38 %), rimettar (22 %) u dijarea (15 %) kienu fost ir-reazzjonijiet avversi rrappurtati bl-aktar mod komuni fl-istudju.
English: Kaplan-Meier curve of PFS (PP population)
Maltese: Kurva ta' Kaplan-Meier ta' PFS (popolazzjoni PP)
English: non-inferiority margin (1.2)
Maltese: marġini ta' nuqqas ta' inferjorità (1.2)
English: Peripheral neuropathies (including the preferred terms neuropathy peripheral, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, and polyneuropathy in malignant disease) were reported in 29% of the patients and were mostly (98%) mild to moderate (CTCAE grade ≤ 2).
Maltese: Newropatiji periferika (inkluż it-termini ppreferuti newropatija periferika, newropatija motorika periferika, newropatija sensimotorja periferali, newropatija sensorja periferika, polinewropatija, u polinewropatija f'marda malinna) ġew irrappurtati f'29 % tal-pazjenti u kienu l-aktar (98 %) ħfief sa moderati (CTCAE grad ≤ 2).
English: For Apealea, dose reductions of initially 50 mg/m2 and additionally 25 mg/m2 should be considered for subsequent courses (see Table 1).
Maltese: Għal Apealea, tnaqqis fid-doża ta' inizjalment 50 mg/m2 u addizzjonalment 25 mg/m2 għandu jiġi kkunsidrat għal korsijiet sussegwenti (ara Tabella 1).
English: • carbamazepine, phenytoin: medicines to treat epilepsy and certain pain conditions
Maltese: • carbamazepine, phenytoin: mediċini biex jittrattaw epilessija u ċerti kondizzjonijiet ta' wġigħ
English: For safety data comparing the results of combination treatment with Apealea (paclitaxel micellar)/carboplatin and solvent-based paclitaxel/carboplatin, see section 4.8.
Maltese: Għal data dwar is-sigurtà li tqabbel ir-riżultati ta' trattament ikkombinat b'Apealea (paclitaxel miċellari)/carboplatin u paclitaxel ibbażat fuq solvent/carboplatin, ara sezzjoni 4.8.
English: Withhold treatment until symptoms resolve to grade ≤ 1
Maltese: Waqqaf it-trattament sakemm is-sintomi jfiequ għal grad ≤ 1
English: Ion
Maltese: Jone
English: The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Maltese: Il-metaboliżmu ta' paclitaxel jiġi katalizzat, parzjalment, miċ-ċitokromu P450 isoenzimi CYP2C8 u CYP3A4
English: Baseline neutrophil count < 1.5 × 109/L.
Maltese: Għadd ta' newtrofili fil-linja bażi < 1.5 × 109/L.
English: * Solutions containing both Ca2+ and Mg2+ should have a total (combined) concentration of Ca2+ and Mg2+ within the range of 1.0 to 3.5 mmol/L.
Maltese: * Soluzzjonijiet li fihom kemm Ca2+ kif ukoll Mg2+ għandu jkollhom konċentrazzjoni totali (kombinata) ta' Ca2+ u Mg2+ fil-medda ta' 1.0 sa 3.5 mmol/L.
English: Overall, there were higher rates of serious adverse events with paclitaxel micellar (41%) than with solvent-based paclitaxel (27%).
Maltese: B'mod globali, kien hemm rati ogħla ta' avvenimenti avversi serji b'paclitaxel miċellari (41 %) milli b'paclitaxel ibbażat fuq solvent (27 %).
English: No pharmacologically active metabolite has been found.
Maltese: Ma nstab l-ebda metabolit attiv farmakoloġikament.
English: The hazard ratios for OS in patients with first and second relapse were 0.98 (95% CI: 0.79;1.21) and 1.18 (95% CI: 0.79;1.75), respectively.
Maltese: Il-proporzjonijiet ta' periklu għal OS f'pazjenti bl-ewwel rikaduta u t-tieni rikaduta kienu 0.98 (CI ta' 95 %: 0.79;1.21) u 1.18 (CI ta' 95 %: 0.79;1.75), rispettivament.
English: Apealea contains a mixture of two retinoic acid derivatives as excipients.
Maltese: Apealea fih taħlita ta' żewġ derivattivi ta' retinoic acid bħala eċċipjenti.
English: Apealea: solvent-based paclitaxel:
Maltese: Apealea: paclitaxel ibbażat fuq solvent:
English: • erythromycin, rifampicin: medicines to treat bacterial infections
Maltese: • erythromycin, rifampicin: mediċini biex jittrattaw infezzjonijiet batteriċi
English: In vitro and in vivo studies have demonstrated that paclitaxel is a substrate for the efflux protein P-glycoprotein.
Maltese: Studji in vitro u in vivo wrew li paclitaxel huwa substrat għall-proteina tal-effluss P-glikoproteina.
English: The main metabolite of paclitaxel is 6α-hydroxypaclitaxel.
Maltese: paclitaxel huwa 6α -hydroxypaclitaxel.
English: Information is lacking for patients with severe renal impairment (GFR < 30 mL/min).
Maltese: Hemm informazzjoni nieqsa għal pazjenti b'indeboliment tal-fwied sever (GFR < 30 mL/min).
English: After reconstitution, the solution contains 1 mg/mL of paclitaxel formulated as micellar nanoparticles.
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni fiha 1 mg/mL ta' paclitaxel formulat bħala nanopartikuli miċellari.
English: Table 2 lists adverse reactions associated with the administration of Apealea in combination with carboplatin observed in a clinical study (N = 391) and adverse reactions from post-marketing experience.
Maltese: Tabella 2 telenka r-reazzjonijiet avversi assoċjati mal-għoti ta' Apealea flimkien ma' carboplatin osservati fi studju kliniku (N = 391) u reazzjonijiet avversi minn esperjenza ta' wara t-tqegħid fis-suq.
English: Paclitaxel was devoid of mutagenic activity in the Ames test or the Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT) gene mutation assay.
Maltese: Paclitaxel kien nieqes minn attività mutaġenika fit-test Ames jew fl-assaġġ ta' mutazzjoni tal-ġene tal-ovarju tal-ħamster Ċiniż/ipoksantina-gwanina fosforibożil trasferażi (CHO/HGPRT).
English: Steps c and to f should not be more than 30 minutes.
Maltese: Passi c sa f m'għandhomx idumu aktar minn 30 minuta.
English: Uncommon: Depression, insomnia, anxiety Nervous system disorders Very common: Peripheral sensory neuropathya,b, neuropathy peripherala,b
Maltese: Komuni ħafna: Newropatija sensorja periferikaa,b, newropatija periferikaa,b
English: Type of premedication
Maltese: Tip ta' premedikazzjoni
English: Effects of age, gender, race and body size
Maltese: Effetti tal-età, tas-sess, tar-razza u tad-daqs tal-ġisem
English: Patients with mildly or moderately impaired renal function (glomerular filtration rate (GFR) 89−60 mL/min or GFR 59−30 mL/min, respectively) may be treated with Apealea without a dose modification.
Maltese: Pazjenti b'funzjoni tal-kliewi indebolita b'mod ħafif jew moderat (rata tal-filtrazzjoni glomerulari (GFR) 89−60 mL/min jew GFR 59−30 mL/min, rispettivament) jistgħu jiġu ttrattati b'Apealea mingħajr modifikazzjoni fid-doża.
English: Second dose level reduction: a Grade of the adverse reaction is defined according to Common Terminology Criteria for Adverse Events (CTCAE).
Maltese: Il-grad tar-reazzjoni avversa huwa definit skont il-Kriterji tat-Terminoloġija Komuni għal Avvenimenti Avversi (CTCAE).
English: In contrast, patients with moderate hepatic impairment (total bilirubin > 1.5 to ≤ 3 × ULN) and severe hepatic impairment (total bilirubin > 3 to ≤ 5 × ULN) had a 22% or a 26% reduction in paclitaxel elimination rate, respectively.
Maltese: B'kuntrast, pazjenti b'indeboliment tal-fwied moderat (bilirubina totali > 1.5 sa ≤ 3 × ULN) u b'indeboliment tal-fwied sever (bilirubina totali > 3 sa ≤ 5 × ULN) kellhom tnaqqis ta' 22 % jew 26 % fir-rata ta' eliminazzjoni ta' paclitaxel, rispettivament.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C in lactated and acetated Ringer's solution and for 4 hours at 2 °C to 8 °C in sodium chloride 9 mg/mL (0.9%) solution when protected from light.
Maltese: f'soluzzjoni lattata u aċetata ta' Ringer u għal 4 sigħat f'temperatura ta' 2 °C sa 8 °C f'soluzzjoni ta' 9 mg/mL (0.9%) sodium chloride meta jiġi protett mid-dawl.
English: The frequency of paclitaxel-related hypersensitivity reactions was similar in both groups (5% of the patients receiving paclitaxel micellar and 7% of the patients receiving solvent-based paclitaxel), whereas a higher frequency of carboplatin-related hypersensitivity reactions was observed in the group receiving paclitaxel micellar (12% vs 7%).
Maltese: Il-frekwenza ta' reazzjonijiet ta' sensittività eċċessiva relatati ma' paclitaxel kienet simili fiż-żewġ gruppi (5 % tal-pazjenti li kienu qed jirċievu paclitaxel miċellari u 7 % tal-pazjenti li kienu qed jirċievu paclitaxel ibbażat fuq solvent), waqt li ġiet osservata frekwenza ogħla ta' reazzjonijiet ta' sensittività eċċessiva relatati ma' carboplatin fil-grupp li kien qed jirċievi paclitaxel miċellari (12 % vs 7 %).
English: Total plasma levels of paclitaxel were similar after infusion of the two formulations.
Maltese: Il-livelli totali ta' paclitaxel fil-plażma kienu simili wara infużjoni taż-żewġ formulazzjonijiet.
English: The non-inferiority criterion was met for OS in the PP population with the upper bound limit of the one-sided 97.5% CI for the associated hazard ratio being less than 1.185 (Table 4; Figures 1 and 2).
Maltese: Il-kriterju ta' nuqqas ta' inferjorità ntlaħaq għal OS fil-popolazzjoni PP bil-limitu superjuri ta' 97.5 % CI minn naħa waħda għallproporzjon ta' periklu assoċjat li jkun inqas minn 1.185 (Tabella 4; Figuri 1 u 2).
English: • stroke
Maltese: • ftuq
English: Progression free survival (independent review) Death or progression, n (%)
Maltese: Mewt jew progressjoni, n (%)
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Maltese: Sensittività eċċessiva severa għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 (ara sezzjoni 4.4).
English: Q3W 175 mg/m2 + carboplatin (N = 333)
Maltese: Paclitaxel ibbażat fuq solvent Q3W 175 mg/m2 + carboplatin (N = 333)
English: Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Maltese: L-istabilizzazzjoni tirriżulta fl-inibizzjoni tal-organizzazzjoni mill-ġdid dinamika normali tan-netwerk tal-mikrotubuli li hija essenzjali għal interfażi importanti u funzjonijiet ċellulari mitotiċi.
English: • an allergic reaction
Maltese: • reazzjoni allerġika
English: The European Medicines Agency has waived the obligation to submit the results of studies with Apealea in all subsets of the paediatric population in the treatment of ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), peritoneal carcinoma (excluding blastomas and sarcomas) and fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'Apealea f'kull subsett tal-popolazzjoni pedjatrika fit-trattament ta' karċinoma tal-ovarji (eskluż rabdomijosarkoma u tumuri taċ-ċellula ġerminali), karċinomi peritoneali (eskluż blastomi u sarkomi) u karċinoma tat-tubu fallopjan (eskluż rabdomijosarkoma u tumuri taċ-ċellula ġerminali (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).