FrancophonIA/ELRC3.0 huggingface dataset:
English: For Kaposi's sarcoma, the dose is 20 mg/m2 every two to three weeks for two to three months, and for multiple myeloma, it is 30 mg/m2 on day four of each three-week cycle of bortezomib treatment, for as long as the patient continues to benefit from the treatment and can tolerate it.
Maltese: Għassarkoma ta' Kaposi, id-doża inizjali hija 20 mg/m2 kull ġimagħtejn sa tliet ġimgħat tul xahrejn sa tliet xhur, u għall-mjeloma multipla, hija 30 mg/m2 fir-raba' jum ta' kull ċiklu ta' tliet ġimgħat ta' trattament bil-bortezomib, u tibqa' sakemm il-pazjent jibqa' jibbenefika mit-trattament u jista' jittollerah.
English: For multiple myeloma, adding Caelyx to bortezomib increased the time until the disease got worse from 6.5 to 9.3 months.
Maltese: Għall-mjeloma multipla, iż-żieda ta' Caelyx ma' bortezomib tawlet iż-żmien sa ma l-marda ggravat minn 6.5 sa 9.3 xhur.
English: The active substance in Caelyx, doxorubicin hydrochloride, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Maltese: Is-sustanza attiva f'Caelyx, id-doxorubicin hydrochloride, hija mediċina ċitotossika li tappartjeni lillgrupp 'antraċiklini'.
English: For metastatic breast cancer, Caelyx has been compared with standard doxorubicin in one main study involving 509 women.
Maltese: Għal kanċer metastatiku fis-sider, Caelyx tqabbel ma' doxorubicin standard fi studju wieħed ewlieni li involva 509 nisa.
English: For advanced ovarian cancer, Caelyx has been compared with topotecan (another anticancer medicine) in one study involving 474 women who had received platinum-based chemotherapy in the past.
Maltese: Għall-kanċer fl-ovarji fi stadju avvanzat, Caelyx tqabbel ma' topotecan (mediċina oħra kontra l-kanċer) fi studju wieħed li involva 474 mara li fl-imgħoddi kienu rċevew kemoterapija bbażata fuq il-platinu.
English: What is Caelyx?
Maltese: X'inhu Caelyx?
English: It cannot be interchanged with other medicines containing doxorubicin hydrochloride.
Maltese: Ma għandux jiġi sostitwit b'mediċini oħra li fihom id-doxorubicin hydrochloride.
English: Why has Caelyx been approved?
Maltese: Għalfejn ġie approvat Caelyx?
English: In Caelyx, it is contained in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Maltese: F'Caelyx, dan ikun jinsab ġewwa lipożomi peġilati (pegylated liposomes, sferi rqajqa li jkun fihom ix-xaħam u jkunu miksijin b'sustanza kimika msejħa polyethylene glycol).
English: For AIDS-related Kaposi's sarcoma, the effectiveness of Caelyx was studied in two main studies involving 384 patients, including 77 who had received treatment before.
Maltese: Għas-sarkoma ta' Kaposi relatata mal-AIDS, l-effikaċja ta' Caelyx ġiet studjata f'żewġ studji ewlenin li involvew 384 pazjent, inklużi 77 li qabel kienu diġà rċevew xi trattament.
English: • advanced ovarian cancer (cancer of the ovary) in women whose previous treatment including a platinum-based anticancer medicine has stopped working;
Maltese: • kanċer tal-ovarji li jkun fi stadju avvanzat f'nisa li t-trattament preċedenti tagħhom ikun inkluda mediċina kontra l-kanċer ibbażata fuq il-platinu li ma baqgħetx effettiva;
English: Caelyx must not be used to treat Kaposi's sarcoma that could be treated effectively with ‘local' treatments that only affect the site of the tumour or with whole-body alfa interferon treatment.
Maltese: Caelyx m'għandux jintuża biex jittratta ssarkoma ta' Kaposi li tkun tista' tiġi ttrattata b'mod effikaċi bi trattamenti 'lokali' li jaffettwaw biss ilpost tat-tumur jew bi trattament alfa-interferon li jaffettwa l-ġisem kollu.
English: Caelyx is concentrate to be made up into a solution for infusion (drip into a vein).
Maltese: Caelyx huwa konċentrat maħsub biex jitħallat f'soluzzjoni għal infużjoni (dripp ġol-vina).
English: Doxorubicin hydrochloride has been available since the 1960s.
Maltese: Id-Doxorubicin hydrochloride ilu disponibbli mis-snin sittin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Caelyx on 21 June 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Caelyx fil-21 ta' Ġunju 1996.
English: For multiple myeloma, the effectiveness of the combination of Caelyx and bortezomib was compared with that of bortezomib alone in 646 patients.
Maltese: Għall-mjeloma multipla, l-effikaċja tal-kombinazzjoni ta' Caelyx u bortezomib tqabblet ma' dik ta' bortezomib waħdu f'646 pazjent.
English: This reduces the rate at which the active substance is broken down, allowing it to circulate in the blood for longer.
Maltese: Dan inaqqas ir-rata ta' tkissir tas-sustanza attiva, u jħalliha tiċċirkola fiddemm għal aktar żmien.
English: • multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already undergone or are unsuitable for a bone marrow transplant.
Maltese: • mjeloma multipla (kanċer fiċ-ċelloli tal-mudullun), f'pazjenti li jkollhom mard progressiv u li jkunu rċevew tal-anqas trattament wieħed ieħor fl-imgħoddi jew li ma jkunx jista' jsirilhom trapjant talmudullun.
English: However, patients receiving Caelyx were less likely to experience heart problems.
Maltese: Madankollu, pazjenti li kienu qegħdin jirċievu Caelyx kellhom inqas possibilità li jkollhom problemi fil-qalb.
English: What is the risk associated with Caelyx?
Maltese: X'inhu r-riskju assoċjat ma' Caelyx?
English: Caelyx is used to treat the following types of cancer in adults:
Maltese: Caelyx jintuża fit-trattament ta' dawn it-tipi ta' kanċer fl-adulti:
English: The additional studies showed that Caelyx was also more effective than the comparator combinations.
Maltese: L-istudji addizzjonali wrew li Caelyx kien aktar effikaċi mill-kombinazzjonijiet kumparattivi.
English: Caelyx should be given under the supervision of a doctor who is qualified in the use of cytotoxic (cellkilling) medicines.
Maltese: Caelyx għandu jingħata taħt is-sorveljanza ta' tabib li jkun ikkwalifikat fl-użu ta' mediċini ċitotossiċi (li joqtlu ċ-ċelloli).
English: Further information on Kineret can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Kineret tista' tinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Kineret, anakinra, is a copy of a natural human protein called ‘human interleukin 1 receptor antagonist'.
Maltese: Is-sustanza attiva f'Kineret, l-anakinra, hija kopja tal-proteina umana naturali msejħa “antagonista tarriċettur interleukin 1 uman”.
English: Kineret received a marketing authorisation valid throughout the European Union on 8 March 2002.
Maltese: Kineret irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fit8 ta' Marzu 2002.
English: • cryopyrin-associated periodic syndromes (CAPS).
Maltese: • sindromi perjodiċi assoċjati mal-kriopirin (CAPS).
English: Other information about Kineret
Maltese: Informazzjoni oħra dwar Kineret
English: For CAPS, Kineret has been studied in one main study involving 43 patients with neonatal-onset multisystem inflammatory disease (NOMID/CINCA syndrome, the most severe form of CAPS).
Maltese: Għal CAPS, Kineret ġie studjat fi studju ewlieni li involva 43 pazjent bil-marda infjammatorja multisistemi fit-trabi tat-twelid (is-sindromu NOMID/CINCA, il-forma l-aktar gravi ta' CAPS).
English: Kineret has been studied in three main studies involving a total of 1,388 patients with rheumatoid arthritis.
Maltese: Kineret ġie studjat fi tliet studji prinċipali li b'kollox involvew 1,388 pazjent b'artrite rewmatojde.
English: • signs and symptoms of rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults.
Maltese: • sinjali u sintomi tal-artrite rewmatojde (marda tas-sistema immunitarja li tikkawża infjammazzjoni fil-ġogi) fl-adulti.
English: The active substance in Kineret, anakinra, is an immunosuppressive medicine (a medicine that reduces the activity of the immune system).
Maltese: Is-sustanza attiva f'Kineret, l-anakinra, hija aġent immunosuppressiv (mediċina li tnaqqas l-attività tas-sistema immunitarja).
English: How is Kineret used?
Maltese: Kif jaħdem Kineret?
English: Results showed that certain doses of Kineret were more effective than placebo in reducing the symptoms of the disease, measured by the doctor and the patient using the ‘American College of Rheumatology' score, which includes measurements of the number of painful or tender joints, disease activity, pain, disability and levels of C reactive protein in the blood (a marker of inflammation).
Maltese: Ir-riżultati wrew li ċerti dożi ta' Kineret kienu aktar effettivi mill-plaċebo fit-tnaqqis tas-sintomi tal-marda, imkejjel mit-tabib u mill-pazjent bl-użu tal-punteġġ tal”Kulleġġ Amerikan tar-Rewmatoloġija”, li jinkludi kejl tan-numru ta' ġogi bl-uġigħ jew rotob, attività ta' mard, uġigħ, diżabbiltà u livelli ta' proteina reattiva C fid-demm (markatur tal-infjammazzjoni).
English: A second study in 24 children showed similar results: 67 % had at least a 30% reduction in symptoms after one month compared with 8 % given placebo.
Maltese: It-tieni studju f'24 wild wera riżultati simili: 67 % kellhom tal-anqas 30 % tnaqqis fis-sintomi wara xahar meta mqabbel mat-8 % mogħtija plaċebo.
English: In the first study, 11 of 15 children with Still's disease (73 %) had at least a 30% reduction in symptoms after three months treatment with Kineret.
Maltese: Fl-ewwel studju, 11 minn 15-il wild bil-marda ta' Still (73 %) kellom tal-anqas 30 % tnaqqis fis-sintomi wara tliet xhur ta' kura b'Kineret.
English: After one month of treatment, more patients on Kineret (6 out of 12 patients) achieved remission compared with treatment with DMARD (3 out of 10 patients).
Maltese: Wara xahar ta' kura, aktar pazjenti li rċivew Kineret (6 minn 12-il pazjent) esperjenzaw remissjoni meta mqabbel mal-kura bi DMARD (3 minn 10 pazjenti).
English: Results showed a significant and rapid improvement in symptoms, with a fall in average symptom score from 4.5 to 0.8 within 3 days of starting treatment.
Maltese: Ir-riżultati wrew titjib sinifikanti u rapidu fis-sintomi, bi tnaqqis fil-punteġġ tas-sintomi medju minn 4.5 għal 0.8 fi tlett ijiem wara li bdiet il-kura.
English: In the study using a fixed dose of Kineret, 38% of the patients adding Kineret had at least a 20% reduction in symptoms after six months, compared with 22% of those adding placebo.
Maltese: Flistudju fejn intużat doża fissa ta' Kineret, 38 % tal-pazjenti li żiedu Kineret kellhom tnaqqis ta' millanqas 20 % fis-sintomi wara sitt xhur, meta mqabbel ma' 22 % ta' dawk li żiedu plaċebo.
English: As for all medicines, data on the use of Kineret are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Kineret hija ssorveljata kontinwament.
English: It blocks the receptors for a chemical messenger in the body called interleukin 1.
Maltese: Hija timblokka r-riċetturi għal messaġġier kimiku fil-ġisem imsejjaħ interleukin 1.
English: In the other two studies, Kineret was used as an add-on to existing treatment including methotrexate: one study, which involved 419 patients, used a range of doses of Kineret that depended on the patient's weight, and the other study, which involved 501 patients, used Kineret at a fixed dose of 100 mg once a day.
Maltese: Fiż-żewġ studji l-oħrajn, Kineret intuża bħala żieda mal-kura eżistenti inkluż il-metotressat: studju minnhom, li involva 419-il pazjent, uża firxa t' dożi ta' Kineret li kieu jiddependu mill-piż tal-pazjent, u l-istudju l-ieħor, li involva 501 pazjenti, uża Kineret bħala doża fissa ta' 100 mg darba kuljum.
English: Kineret must not be used in people who are hypersensitive (allergic) to anakinra, to any of the other ingredients, or to proteins produced by Escherichia coli (a type of bacterium).
Maltese: Kineret ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għall-anakinra, kwalunkwe sustanza oħra tiegħu, jew għal proteini prodotti minn Escherichia coli (tip ta' batterju).
English: CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopyrin.
Maltese: CAPS huma grupp ta' mard fejn il-pazjenti jkollhom difett fil-ġene li jipproduċi proteina li tissejjaħ kriopirin.
English: Kineret should be used with caution in patients who have severely reduced liver function or moderately reduced kidney function.
Maltese: Kineret jenħtieġ li jintuża b'attenzjoni minn pazjenti li jbatu minn tnaqqis gravi fil-funzjoni tal-fwied jew tnaqqis moderat fil-funzjoni tal-kliewi.
English: What are the risks associated with Kineret?
Maltese: X'inhuma r-riskji assoċjati ma' Kineret?
English: The most common side effects with Kineret (which may affect more than 1 patient in 10) are headache, injection site reactions (redness, bruising, pain and inflammation), and increase in blood cholesterol.
Maltese: L-effetti sekondarji l-aktar komuni b'Kineret (li jistgħu jaffettwaw aktar minn pazjent 1 minn kull 10) huma wġigħ ta' ras, reazzjonijiet fis-sit tal-injezzjoni (ħmura, tbenġil, uġigħ u infjammazzjoni) u żieda fil-kolesterol tad-demm.
English: The recommended dose of Kineret for rheumatoid arthritis is 100 mg once a day, given at around the same time each day.
Maltese: Id-doża rakkomandata ta' Kineret għall-artrite rewmatojde hija 100 mg darba kuljum, mogħtija bejn wieħed u ieħor fl-istess ħin tal-ġurnata kuljum.
English: All three studies compared the effectiveness of Kineret with that of placebo (a dummy treatment).
Maltese: Ittliet studji qabblu l-effikaċja ta' Kineret ma' dik tal-plaċebo (kura finta).
English: It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients who have not responded adequately to methotrexate alone;
Maltese: Jintuża f'kombinazzjoni ma' metotressat (mediċina użata biex tnaqqas linfjammazzjoni) f'pazjenti li ma jkunux irrispondew b'mod adegwat għal metotressat waħdu;
English: This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain and tiredness.
Maltese: Dan iwassal għal infjammazzjoni f'diversi partijiet tal-ġisem, b'sintomi bħal deni, raxx, uġigħ fil-ġogi u għeja.
English: Kineret is a medicine that is used to treat:
Maltese: Kineret huwa mediċina li tintuża biex tikkura:
English: Side effects reported with Kineret are carefully evaluated and any necessary action is taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Kineret jiġu evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The European Medicines Agency decided that Kineret's benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Kineret huma akbar mir-riskji tiegħu għall-kura tas-sinjali u s-sintomi tal-artrite rewmatojde f'kombinazzjoni ma' metotressat, f'pazjenti b'rispons mhux adegwat għal metotressat waħdu.
English: For the full list of side effects of Kineret, see the package leaflet.
Maltese: Għall-marda ta' Still, twettqu tliet studji żgħar.
English: The first study included 468 patients, some of whom had taken other medicines for their disease in the past, and who were given either Kineret on its own or placebo.
Maltese: L-ewwel studju inkluda 468 pazjent, li xi wħud minnhom kienu ħadu mediċini oħrajn għall-marda tagħhom fil-passat, u li ngħataw jew Kineret waħdu jew plaċebo.
English: For CAPS and Still's disease, Kineret is used in patients from 8 months of age and weighing at least 10 kg. Kineret contains the active substance anakinra.
Maltese: Għal CAPS u għall-marda ta' Still, Kineret jintuża f'pazjenti minn 8 xhur 'il fuq u li tal-anqas ikunu jiżnu 10 kg.
English: For CAPS and Still's disease, the dose depends on body weight and for CAPS, on the severity of the condition.
Maltese: Għal CAPS u għall-marda ta' Still, id-doża tiddependi mill-piż tal-ġisem u għal CAPS, mis-severità talkundizzjoni.
English: By attaching to the receptors that interleukin 1 would normally attach itself to, anakinra blocks the activity of interleukin 1, helping to relieve the symptoms of these diseases.
Maltese: Billi teħel mar-riċetturi li normalment interleukin 1 jeħel magħhom, l-anakinra timblokka l-attività ta' interleukin 1, u dan jgħin biex jittaffew is-sintomi ta' dan il-mard.
English: Patients were given Kineret at a starting dose of 1 to 2 mg per kg body-weight daily, increased after a month if necessary.
Maltese: Il-pazjenti ngħataw Kineret b'doża li tibda minn 1 mg sa 2 mg għal kull kg tal-piż tal-ġisem kuljum, li tiżdied wara xahar jekk ikun meħtieġ.
English: Chi-square test.
Maltese: Test Chi-square.
English: Volume of distribution c, d,
Maltese: Volum ta' distribuzzjoni ċ, d,
English: N=3 N=5 N=7 N=10 N=6 N=5
Maltese: N=5 N=7 N=10 N=6 N=5
English: haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone;
Maltese: erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone;
English: Manufacturer Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Maltese: Manifattur Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, Ir-Renju Unit
English: Hospira Enterprises B.V. Randstad 22-11 Almere NL-1316 BN The Netherlands
Maltese: Hospira Enterprises B.V. Randstad 22-11 Almere NL-1316 BN L-Olanda
English: Date of first authorisation: 08 April 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 8 ta' April 2016
English: Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), Italy
Maltese: Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), L-Italja
English: HOSPIRA Enterprises B.V., Randstad 22-11, 1316 BN Almere, The Netherlands
Maltese: HOSPIRA Enterprises B.V., Randstad 22-11, 1316 BN Almere, L-Olanda
English: Approximately 62 % of palonosetron is bound to plasma proteins.
Maltese: Madwar 62% ta' palonosetron jintrabat mal-proteini tal-plażma.
English: Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgium
Maltese: Pfizer Service Company BVBA, Hoge Wei 10, 1930
English: In the palonosetron 10 μg/kg, 20 μg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
Maltese: Fil-gruppi ta' palonosetron 10 µg/kg, 20 µg/kg u ta' ondansetron, il-proporzjon ta' pazjenti b'CR0-24 siegħa kien ta' 54.2%, 59.4% u 58.6%.
English: 24 - 120 hours 0 - 120 hours No Nausea (Likert Scale)
Maltese: 24 - 120 hours 0 - 120 hours L-Ebda Dardir (Skala Likert)
English: Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Maltese: Takikardija, bradikardija, ekstrasistoli, iskemija mijokardjali, takikardija tassinus, arritmija tas-sinus, ekstrasistoli supraventrikulari
English: Very rare ARs°
Maltese: ARs rari ħafna
English: CYP2D6 inducers and inhibitors.
Maltese: Indutturi u inibituri ta' CYP2D6
English: A total of 670 paediatric surgical patients participated, age 30 days to 16.9 years.
Maltese: Total ta' 670 pazjent pedjatriċi kirurġiċi pparteċipaw, u kellhom minn 30 jum sa 16.9 snin.
English: Efficacy after palonosetron 10 μg/kg compared to palonosetron 3 μg/kg was 54.1% and 37.1% respectively.
Maltese: Leffikaċja wara doża ta' 10 µg/kg ta' palonosetron meta mqabbla ma' doża ta' 3 µg/kg ta' palonosetron kienet 54.1% u 37.1% rispettivament.
English: In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine).
Maltese: F'analiżi farmakokinetika tal-popolazzjoni, intwera li ma kien hemm l-ebda effett sinifikanti fuq ittneħħija ta' palonosetron meta jingħata flimkien ma' indutturi CYP2D6 (dexamethasone u rifampicin) u inibituri (li jinkludu amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline jew terbinafine).
English: Palonosetron Hospira is indicated in adults for:
Maltese: Palonosetron Hospira hu indikat fl-adulti għall-:
English: • SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
Maltese: • SSRIs (selective serotonin reuptake inhibitors - inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin) li jintużaw għall-kura tad-depressjoni u/jew ansjetà, li jinkludu fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
English: Dermatitis allergic, pruritic rash
Maltese: Dermatite allerġika, raxx bilħakk
English: • SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Maltese: • SNRIs (serotonin noradrenaline reuptake inhibitors - inibituri tal-assorbiment mill-ġdid ta' noradrenaline ta' serotonin) li jintużaw għall-kura tad-depressjoni u/jew ansjetà, li jinkludu venlafaxine, duloxetine.
English: Table 4: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of palonosetron at 20 μg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 μg/kg palonosetron doses via intravenous bolus.
Maltese: Tabella 4: Parametri Farmakokinetiċi f'Pazjenti Pedjatriċi bil-Kanċer wara infużjoni ġol-vini ta' Palonosetron f'doża ta' 20 µg fuq perjodu ta' 15-il minuta u f'Pazjenti Adulti bil-Kanċer li jirċievu dożi ta' 3 u 10 µg/kg ta' palonosetron permezz ta' bolus ġol-vini.
English: Also contains: mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide, hydrochloric acid.
Maltese: Fih ukoll mannitol, disodium edetate, sodium citrate, citric acid monohydrate, ilma għall-injezzjonijiet, sodium hydroxide, hydrochloric acid.
English: Clearance c, L/h/kg
Maltese: Tneħħija ċ, L/h/kg
English: However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolisers of CYP2D6 substrates.
Maltese: Madanakollu, il-parametri farmakokinetiċi kliniċi mhumiex differenti b'mod sinifikanti bejn metabolizzaturi batuti u estensivi tas-sottostrati ta' CYP2D6.
English: When the dose was increased from 10 μg/kg to 20 μg/kg a dose-proportional increase in mean AUC was observed.
Maltese: Meta d-doża żdiedet minn 10 µg/kg għal 20 µg/kg, ġiet osservata żieda proporzjonali għad-doża fil-medja tal-AUC.
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 μg/kg or 3 μg/kg (88% vs 84%).
Maltese: Il-proporzjon ta' pazjenti mingħajr rimettar matul 0-72 siegħa wara l-operazzjoni kien simili wara l-għoti ta' 1 µg/kg jew 3 µg/kg ta' palonosetron (88% vs 84%).
English: Allergic reactions to Palonosetron Hospira.
Maltese: Reazzjonijiet allerġiċi għal Palonosetron Hospira.
English: Each vial contains 250 micrograms palonosetron (as hydrochloride) in 5 ml (50 micrograms/ml)
Maltese: Kull kunjett fih 250 mikrogramma ta' palonosetron (bħala hydrochloride f'5 ml (50 mikrogramma/ml)
English: Since the 97.5% confidence interval (stratum adjusted Mantel-Haenszel test) of the difference in CR0-24h between palonosetron 20 μg/kg and ondansetron was [-11.7%, 12.4%], the 20 μg/kg palonosetron dose demonstrated non-inferiority to ondansetron.
Maltese: Billi l-intervall ta' kunfidenza ta' 97.5% (test ta' Mantel-Haenszel aġġustat għall-istratum) tad-differenza f'CR0-24 siegħa bejn palonosetron 20 µg/kg u ondansetron kien ta' [11.7%, 12.4%], id-doża ta' palonosetron 20 µg/kg uriet nuqqas ta' inferjorità għal ondansetron.