FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should be aware of the possible occurrence of an anaphylactic reaction with VEPESID and associated names, manifested by chills, pyrexia, tachycardia, bronchospasm, dyspnoea and hypotension, which can be fatal.
Maltese: It-tobba għandhom ikunu konxji mill-okkorrenza possibbli ta' reazzjoni anafilattika b'VEPESID u ismijiet assoċjati, li tidher bħala tertir ta' bard, deni, takikardija, bronkospażmu, qtugħ ta' nifs u pressjoni baxxa, li jistgħu jkunu fatali.
English: Acute myeloid leukaemia
Maltese: Lewkimja majelodje akuta
English: • bleeding
Maltese: • sturdament
English: Pregnancy
Maltese: Manifattur
English: Dose limiting bone marrow suppression is the most significant toxicity associated with VEPESID and associated names therapy.
Maltese: Soppressjoni tal-mudullun li tillimita d-doża hi l-aktar tossiċità sinifikanti assoċjata ma' terapija b'VEPESID u ismijiet assoċjati.
English: Do not open any blister in which there is evidence of capsule leakage.
Maltese: M'għandekx tiftaħ kwalunkwe folja li fiha jkun hemm evidenza ta' tnixxija mill-kapsula.
English: VEPESID and associated names capsules contain sodium propyl parahydroxybenzoate and sodium ethyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Maltese: Il-kapsuli VEPESID u ismijiet assoċjati fihom sodium propyl parahydroxybenzoate u sodium ethyl parahydroxybenzoate li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jittardjaw).
English: The coefficient of variation is around 30% after oral administration versus 10% after intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30 to 40%).
Maltese: Il-koeffiċjent tal-varjazzjoni hu ta' madwar 30% wara l-għoti orali kontra 10% wara l-għoti ġol-vini (il-varjabilità bejn pazjent u ieħor hi simili wara l-għoti ġol-vini jew orali, i.e. 30 sa 40%).
English: In patients with creatinine clearance less than 15 mL/min and on dialysis further dose reduction is likely to be required as etoposide clearance is further reduced in these patients.
Maltese: F'pazjenti bi tneħħija tal-kreatinina ta' inqas minn 15 mL/min u li jkunu fuq id-dijalisi, tnaqqis addizzjonali fid-doża x'aktarx li jkun meħtieġ, għax it-tneħħija ta' etoposide titnaqqas b'mod ulterjuri f'dawn il-pazjenti.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory acute myeloid leukaemia in adults.
Maltese: VEPESID u ismijiet assoċjati huwa indikat flimkien ma' sustanzi kimoterapewtiċi oħra approvati għall-kura ta' lewkimja majelodje akuta rikorrenti jew refrattorja fl-adulti.
English: In children, elevated SGPT levels are associated with reduced drug total body clearance.
Maltese: Fit-tfal, livelli għoljin ta' SGPT huma assoċjati tnaqqis fit-tneħħija totali tal-mediċina mill-ġisem.
English: NAME OF THE MEDICINAL PRODUCT VEPESID and associated names 50mg Soft Capsules VEPESID and associated names 100mg Soft Capsules [See Annex I - To be completed nationally] Etoposide
Maltese: Informazzjoni għall-pazjent VEPESID u ismijiet assoċjati (ara Anness I) kapsula ratba ta' 50 mg VEPESID u ismijiet assoċjati (ara Anness I) kapsula ratba ta' 100 mg
English: The following haematological parameters should be measured at the start of therapy and prior to each subsequent dose of VEPESID and associated names: platelet count, haemoglobin, white blood cell count and differential.
Maltese: Il-parametri ematoloġiċi li ġejjin għandhom jitkejlu fil-bidu tat-terapija u qabel kull doża sussegwenti ta' VEPESID u ismijiet assoċjati: għadd tal-plejtlits, emoglobina, għadd taċ-ċelluli tad-demm bojod u differential.
English: Each capsule contains etoposide 50 mg or 100 mg as the active ingredient.
Maltese: 100 mg bħala s-sustanza attiva.
English: Patients with impaired hepatic function should regularly have their hepatic function monitored due to the risk of accumulation.
Maltese: Pazjenti b'funzjoni indebolita tal-fwied għandu jkollhom il-funzjoni tal-fwied tagħhom immonitorjata regolarment minħabba r-riskju ta' akkumulazzjoni.
English: Over the same dose range, the areas under the plasma concentration vs. time curves (AUC) and the maximum plasma concentration (Cmax) values increase linearly with dose.
Maltese: Matul l-istess medda ta' doża, iż-żoni taħt il-kurvi tal-konċentrazzjoni filplażma kontra l-ħin (AUC) u l-valuri tal-konċentrazzjoni massima fil-plażma (Cmax) jiżdiedu b'mod lineari mad-doża.
English: • damage to the liver (hepatotoxicity) Common side effects (affecting between 1 in 10 and 1 in 100 people)
Maltese: Effetti sekondarji komuni (li jaffettwaw bejn 1 u 10 u 1 minn kull 100 persuna) • lewkimja akuta
English: VEPESID and associated names 50mg Soft Capsules VEPESID and associated names 100mg Soft Capsules [See Annex I - To be completed nationally]
Maltese: VEPESID u ismijiet assoċjati Kapsuli Rotob ta' 50 mg VEPESID u ismijiet assoċjati Kapsuli Rotob ta' 100mg]
English: • serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
Maltese: • reazzjonijiet serji tal-ġilda u/jew tal membrani mukużi, li jistgħu jinkludu infafet bl-uġigħ u deni, li jinkludu li l-ġilda tinqala' b'mod estensiv (sindrome ta' Stevens-Johnson u nekrolisi epidermali tossika).
English: Severe liver, kidney or heart damage from a condition called tumour lysis syndrome, caused by harmful amounts of substances from the cancer cells getting into the blood stream, has been seen sometimes when VEPESID is taken along with other drugs used to treat cancer.
Maltese: Ilparametri ematoloġiċi għandhom jitkejlu, u għandhom jiġu kkunsidrati aġġustamenti f'ċikli sussegwenti skont it-tossiċità ematoloġika u l-effett kliniku f'pazjenti b'indeboliment moderat u sever tal-kliewi.
English: VEPESID and associated names should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician.
Maltese: VEPESID u ismijiet assoċjati għandhom jitwaqqfu immedjatament, u jiġu segwiti mill-għoti ta' sustanzi pressor, kortikosterojdi,
English: • feeling weak (asthenia)
Maltese: • ħsara lill-fwied (epatotossiċità)
English: • tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood)
Maltese: • sindrome tal-lisi tat-tumur (kumplikazzjonijiet ta' sustanzi li jintreħew minn ċelluli tal-kanċer ikkurati li jidħlu fiċ-ċirkolazzjoni tad-demm)
English: Microtubule assembly is not affected.
Maltese: L-assemblaġġ tal-mikrotubuli ma jiġix affettwat.
English: Thrombocytopenia and severe thrombocytopenia (less
Maltese: rari tibdil fis-sens tat-togħma, disfaġija
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults.
Maltese: VEPESID u ismijiet assoċjati huwa indikat flimkien ma' sustanzi kimoterapewtiċi oħra approvati għall-kura ta' kanċer testikolari rikorrenti jew refrattorju fl-adulti.
English: Each soft capsule contains 50mg of etoposide
Maltese: Kull kapsula fiha 50 mg ta' etoposide Kull kapsula fiha 100 mg ta' etoposide
English: Follow up doses should be adjusted in case of occurrence of grade 3 or 4 toxicities or if renal creatinine clearance is below 50 ml/min.
Maltese: Id-dożi ta' wara għandhom jiġu aġġustati fil-każ tal-okkorrenza ta' tossiċitajiet ta grad 3 jew 4 jew jekk it-tneħħija tal-kreatinina mill-kliewi tkun inqas minn 50 mL/min.
English: A decision must be made whether to discontinue breastfeeding or to discontinue VEPESID and associated names, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman (see section 4.3).
Maltese: Gћandha tittieћed deċiżjoni jekk il-mara twaqqafx it-treddigћ jew twaqqafx it-trattament b'VEPESID, wara li jigi kkunsidrat il benefiċċju ta' treddigћ gћat-tarbija u l-benefiċċju tat-trattament gћall-mara (ara sezzjoni 4.3).
English: Concomitant phenytoin therapy is associated with increased etoposide clearance and reduced efficacy, and other enzyme-inducing antiepileptic therapy may be associated with increased VEPESID and associated names clearance and reduced efficacy.
Maltese: Terapija b'phenytoin fl-istess ħin hi assoċjata ma' żieda fit-tneħħija ta' etoposide u effikaċja mnaqqsa, u terapija oħra kontra l-epilessija li tinduċi l-enzimi tista' tkun assoċjata ma' żieda fittneħħija ta' VEPESID u ismijiet assoċjati u tnaqqis fl-effikaċja.
English: OTHER Cytotoxic.
Maltese: OĦRAJN Ċitotossiku.
English: Immune system disorders rare anaphylactic reactions not known angioedema, bronchospasm Metabolism and nutrition disorders not known tumour lysis syndrome
Maltese: Disturbi fil-metaboliżmu u n nutrizzjoni mhux magħruf sindrome tal-lisi tat-tumur
English: Tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide in association with other chemotherapeutic drugs.
Maltese: Sindrome tal-lisi tat-tumur (xi kultant fatali) ġie rrappurtat wara l-użu ta' etoposide flimkien ma' mediċini kimoterapewtiċi oħra.
English: Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy (see section 4.4), which may have compromised bone marrow reserve.
Maltese: Id-dożaġġ għandu jiġi modifikat biex jiġu kkunsidrati l-effetti majelosuppressivi ta' mediċini oħra fil kombinazzjoni jew l-effetti ta' radjuterapija jew kimoterapija fil-passat (ara sezzjoni 4.4), li setgħu kkompromettew ir-riserva tal-mudullun.
English: FDG-NEGATIVE
Maltese: FDG-NEGATTIV
English: Insomnia a.
Maltese: Insomnja a.
English: Pack of 1 vial.
Maltese: Pakkett ta' kunjett 1.
English: Per Ann Arbor Staging IPFP = International Prognostic Factor Project
Maltese: Skont l-Istadji Ann Arbor IPFP = International Prognostic Factor Project
English: Doxorubicin, vinblastine and dacarbazine (AVD)
Maltese: Doxorubicin, vinblastine u dacarbazine (AVD)
English: MMAE is a substrate of CYP3A4 and possibly CYP2D6.
Maltese: MMAE huwa substrat ta' CYP3A4 u possibbilment ta' CYP2D6.
English: (95% CI [0.40, 0.81]) Stratified log-rank test p=0.001
Maltese: (95% CI [0.40, 0.81]) Test ta' log-rank stratifikat P=0.001
English: 4 years.
Maltese: 4 snin.
English: Overall response rates for MF were 54-66%; pcALCL, 67%; SS, 50%; LyP, 92%; and mixed CTCL histology, 82-85%.
Maltese: Irrati ta' rispons globali għal MF kienu 54-66%; pcALCL, 67%; SS, 50%; LyP, 92%; u istoloġija CTCL mħallta, 82-85%.
English: Pulmonary toxicity
Maltese: Tossiċità pulmonari
English: 3.6 vials a.
Maltese: 3.6 kunjetti a.
English: B symptoms
Maltese: Sintomi B
English: Herpes zoster, Pneumocystis jiroveci pneumonia
Maltese: Herpes zoster, Pulmonite tal-pneumocystis jiroveci
English: 2.4 vials a.
Maltese: 2.4 kunjetti a.
English: Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers)
Maltese: Interazzjoni ma' prodotti mediċinali metabolizzati permezz tar-rotta CYP3A4 (inibituri/indutturi ta' CYP3A4)
English: A negative JCV PCR does not exclude PML.
Maltese: PCR negattiva għal JCV ma teskludix PML.
English: Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG United Kingdom
Maltese: Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG United Kingdom
English: ECOG status
Maltese: stat ECOG
English: Serious infections and opportunistic infections
Maltese: Infezzjonijiet serji u infezzjonijiet opportunistiċi
English: Prior ASCT
Maltese: ASCT preċedenti
English: Pancreatitis acute
Maltese: Pankreatite akuta
English: 31 years (15-77)
Maltese: 31 sena (15-77)
English: Herpes zoster, pneumonia, herpes simplex, oral candidiasis
Maltese: Herpes zoster, pulmonite, herpes simplex, kandidijasi orali
English: 9/L, fever ≥ 38.5
Maltese: 9/L, deni ≥ 38.5 °C; ref
English: Percent Difference (95% CI)
Maltese: Differenza Perċentwali (95% CI)
English: 18.8 mo (7.4-180.8)
Maltese: 18.8 xh (7.4-180.8)
English: 52 years (14-76)
Maltese: 52 sena (14-76)
English: Anaemia, thrombocytopenia
Maltese: Anemija, tromboċitopenija
English: Store in a refrigerator (2 °C-8 °C).
Maltese: Aħżen fi friġġ (2 °C-8 °C).
English: See section 2 for further information about sodium.
Maltese: Ara sezzjoni 2 għal aktar informazzjoni dwar sodium.
English: MMAE did not induce any major CYP450 enzymes in primary cultures of human hepatocytes.
Maltese: MMAE ma ikkaġuna l-ebda enzimi CYP450 maġġuri f'kulturi primarji ta' epatoċiti umani.
English: The RP2D was determined to be 1.8 mg/kg.
Maltese: L-RP2D ġiet stabbilita li hi 1.8 mg/kg.
English: 42.9 months (95% CI [30.4, 42.9])
Maltese: 42.9 xahar (95% CI [30.4, 42.9])
English: In vitro, the binding of MMAE to human serum plasma proteins ranged from 68-82%.
Maltese: In vitro, it-twaħħil ta' MMAE ma' proteini umani fis-serum varja minn 68-82%.
English: Grade 4 (< 500/mm < 0.5 x 10
Maltese: Grad 4 (< 500/mm < 0.5 x 10
English: For further efficacy results, see Table 12 and Figure 5.
Maltese: Għall-aktar riżultati ta' effikaċja ara Tabella 12 u Figura 5.
English: Pneumonia, oral candidiasis, sepsis/septic shock, herpes simplex
Maltese: Pulmonite, kandidjażi orali, sepsis/xokk settiku, herpes simplex
English: Pharmacotherapeutic group: Antineoplastic agents; other antineoplastic agents; monoclonal antibodies, ATC code: L01XC12
Maltese: Sustanzi antineoplastiċi; sustanzi anti-neoplastiċi oħra; antikorpi monoklonali, Kodiċi ATC: L01XC12
English: Premedication may include paracetamol, an antihistamine and a corticosteroid.
Maltese: Premedikazzjoni tista' tinkludu paracetamol, antistamina u kortikosterojd.
English: Gastrointestinal complications
Maltese: Kumplikazzjonijiet gastrointestinali
English: Per IRF, the objective response rate (ORR) in the ITT population was 50% (95% CI, 37; 63%).
Maltese: Skont IRF, ir-rata ta' rispons oġġettiv (ORR, objective response rate) fil-popolazzjoni ITT kienet ta' 50% (95% CI, 37; 63%).
English: Percent Difference (95% CI) p-value
Maltese: Differenza Perċentwali (95% CI) valur p
English: Adcetris contains sodium
Maltese: Adcetris fih sodium
English: 76M (46%)/89F (54%) 97M (59%)/67F (41%)
Maltese: 76R (46%)/89N (54%) 97R (59%)/67N (41%)
English: Stage IV
Maltese: Stadju IV
English: 15.8 months (95% CI [8.5, -])
Maltese: 15.8 xahar (95% CI [8.5, -])
English: Final Study Report by: Q1 2021
Maltese: Q1 2021
English: 1.44 vials
Maltese: 1.44 kunjetti
English: - The active substance is brentuximab vedotin.
Maltese: - Is-sustanza attiva hija brentuximab vedotin.
English: Estimated mPFS
Maltese: mPFS
English: Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased
Maltese: Alanine aminotransferase/aspartate Żieda fl-aminotransferase (ALT/AST)
English: Number of Risk Factors = 1
Maltese: Għadd ta' Fatturi ta' Riskju = 1
English: The most common prior systemic therapies in the ITT population were chemotherapy (71%), immunotherapy (43%) and bexarotene (38%).
Maltese: L-aktar terapiji sistemiċi komuni fil-passat fil-popolazzjoni ITT kienu kimoterapija (71%), immunoterapija (43%) u bexarotene (38%).
English: 58.5 years (22-83)
Maltese: 58.5 snin (22-83)
English: Total volume per vial (10 mL/vial)
Maltese: Volum totali kull kunjett (10 mL/kunjett)
English: Study SGN35-005
Maltese: Studju SGN35-005
English: Complete remission (CR) was 33% (34 of 102 patients in the ITT set).
Maltese: Remissjoni kompluta (CR) kienet ta' 33% (34 minn 102 pazjenti fil-grupp ITT).
English: The estimated overall survival at 5 years was 60% (95% CI [47%,73%]).
Maltese: Is-sopravivenza globali wara 5 snin kienet stmata bħala 60% (95% CI [47%,73%]).
English: 62 years (22-83)
Maltese: 62 sena (22-83)
English: 24.1 months (95% CI [11.5, -])
Maltese: 24.1 xahar (95% CI [11.5, -])
English: The estimated overall survival rate at 5 years was 41% (95% CI [31%, 51%]).
Maltese: Ir-rata globali ta' sopravivenza stmata wara 5 snin kienet ta' 41% (95% CI [31%, 51%]).
English: p-value=0.199
Maltese: Valur-P=0.199
English: Total dose = patient weight multiplied by recommended dose [1.8 mg/kg a])
Maltese: Doża totali = Piż tal-pazjent multiplikat bid-doża rrakkomandata [1.8 mg/kg a])
English: Adverse reactions for ADCETRIS are listed by MedDRA System Organ Class and Preferred Term (see Table 3).
Maltese: Reazzjonijiet avversi għal ADCETRIS huma elenkati skont is-Sistema tal-Klassifika tal-Organi u t-Terminu Ppreferut MedDRA (ara Tabella 3).
English: Placebo n = 136
Maltese: Plaċebo n = 136
English: 18.7 mo (6.1-204.0)
Maltese: 18.7 xh (6.1-204
English: The recommended dose of ADCETRIS is infused over 30 minutes.
Maltese: Id-doża rrakkomandata ta' ADCETRIS hija infuża fuq perijodu ta' 30 minuta.
English: 1.92 vials
Maltese: 1.92 kunjetti
English: Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Denmark
Maltese: Takeda Pharma A/S Dybendal Alle 10
English: The frequency of unique serious adverse drug reactions was ≤ 1%.
Maltese: Il-frekwenza ta' reazzjonijiet avversi serji serji uniċi kien ta' ≤ 1%.
English: Objective Response Rate lasting at least 4 months (ORR4) per IRF n (%)
Maltese: Rata ta' Rispons Oġġettivi li ddum mill-inqas 4 xhur (ORR4) skont IRF N (%)
English: 32 years (18-76)
Maltese: 32 sena (18-76)
English: Table 3: Adverse reactions to ADCETRIS
Maltese: Tabella 3: Reazzjonijiet avversi għal ADCETRIS
English: Arthralgia, myalgia
Maltese: Artralġija, majalġja
English: Placebo n = 28
Maltese: Plaċebo n = 28
English: A. POTAMITIS MEDICARE LTD Tηλ: +357 22583333 info@potamitismedicare.com
Maltese: MEDICARE LTD Tηλ: +357 22583333 info@potamitismedicare.com
English: Tel. +358 20 746 5000 infoposti@takeda.com
Maltese: +358 20 746 5000 infoposti@takeda.com
English: Alanine aminotransferase (ALT) increased
Maltese: Żieda fl-alanine aminotransferase (ALT)
English: Total dose = patient weight multiplied by recommended dose [1.2 mg/kg a])
Maltese: Doża totali = piż tal-pazjent immultiplikat bid-doża rakkomandata [1.2 mg/kg a])
English: p-value=0.035
Maltese: Valur-P=0.035
English: In a phase 1 dose finding and safety study (SGN35-009), unacceptable pulmonary toxicity (including 2 fatal events) was noted in 11 of 25 patients (44%) treated with brentuximab vedotin plus ABVD.
Maltese: Fi studju tad-dożaġġ u s-sigurtà tal-ewwel fażi (SGN35-009), tossiċità pulmonari mhux aċċettabbli (inkluż żewġ avvenimenti fatali) ġiet innotata fi 11 minn 25 pazjent (44%) trattati bi brentuximab vedotin u ABVD.
English: Severity grade of neutropenia (signs and symptoms [abbreviated description of CTCAE a])
Maltese: Grad ta' severità tan-newtropenija (sinjali u sintomi [deskrizzjoni mqassra ta' CTCAE a])
English: Patient characteristics n = 58
Maltese: Karatteristiċi tal-pazjenti n = 58
English: Stratified log-rank test was not performed for PFS per Investigator.
Maltese: Test ta' log-rank stratifikat ma twettaqx għal PFS kull Investigatur
English: ADCETRIS dose (mg/kg) x patient's body weight (kg)
Maltese: Doża ta' ADCETRIS (mg/kg) x piż tal-ġisem talpazjent (kg)
English: In the pooled dataset of ADCETRIS as monotherapy across HL, sALCL and CTCL studies (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 and C25007, see section 5.1) the most frequent adverse reactions (≥ 10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain.
Maltese: Fis-sett ta' dejta miġbura ta' ADCETRIS bħala monoterapija f'HK, sALCL u studji CTCL (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 u C25007, ara sezzjoni 5.1) reazzjonijiet avversi frekwenti (≥10%) kienu infezzjonijiet, newropatija motorja periferali, tqalligħ, għeja, dijarea, deni, infezzjoni fil-passaġġ respiratorju ta' fuq, newtropenija, raxx, sogħla, rimettar, altralġija, newropatija motorja periferali, reazzjonijiet relatati mal-infużjoni, ħakk, stitikezza, qtugħ ta' nifs, tnaqqis fil-piż, mijalġija u wġigħ addominali.
English: The elimination of MMAE was limited by its rate of release from ADC, typical apparent CL and half life of MMAE was 19.99 l/day and 3-4 days respectively.
Maltese: L-eliminazzjoni ta' MMAE kienet limitata mir-rata ta' rilaxx tiegħu minn ADC, CL u half life apparenti tipiċi ta' MMAE kienu ta' 19.99 l/jum u 3-4 tijiem rispettivament.
English: Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Austria
Maltese: Peter-Straβe 25 A-4020
English: PET scan Status prior to ASCT FDG-AVID
Maltese: Stat tal-isken PET qabel ASCT FDG-AVID
English: MMAE is the major metabolite of brentuximab vedotin.
Maltese: MMAE huwa l-metabolit prinċipali ta' brentuximab vedotin.
English: Severity of peripheral sensory or motor neuropathy (signs and symptoms [abbreviated description of CTCAE
Maltese: Severità ta' newropatija sensorjali jew motorja periferali (sinjali u sintomi [deskrizzjoni mqassra ta' CTCAE
English: Based on population PK estimation the typical apparent central volume of distribution of MMAE was 35.5 l
Maltese: Ibbażat fuq stima ta' PK tal-popolazzjoni l-volum ċentrali apparenti ta' distribuzzjoni tipiku ta' MMAE kienu ta' 35.5 L.
English: Reduce dose to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks
Maltese: Naqqas id-doża għal 0.9 mg/kg sa massimu ta' 90 mg kull ġimagħtejn
English: The frequency of febrile neutropenia was 11% in patients who received primary prophylaxis with G-CSF.
Maltese: Il-frekwenza tan-newtropenija bid-deni kienet ta' 11% fil-pazjenti li rċevew profilassi primarja b'G-CSF.
English: In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology.
Maltese: II b'parti waħda dwar ADCETRIS, intweriet attività tal-marda fis-sottotipi tas-sindrome ta' Sézary (SS), lymphomatoid papulosis (LyP) u istoloġija CTCL imħallta.
English: Retreatment with ADCETRIS resulted in 6 CRs (55%) and 4 PRs (36%), for an ORR of 91%.
Maltese: Il-kura mill-ġdid b'ADCETRIS irriżultat f'6 CRs (55%) u 4 PRs (36%), għal ORR ta' 91%.
English: The maximal recommended dose is 180 mg.
Maltese: Id-doża massima rrakkomandata hija ta' 180 mg.
English: Infection a, upper respiratory tract infection Infection a, upper respiratory tract infection
Maltese: Infezzjoni a, fin-naħa ta' fuq tal-apparat respiratorju
English: Study C25001
Maltese: Studju C25001
English: 2.16 vials
Maltese: 2.16 kunjett
English: The efficacy in elderly patient population (patients ≥ 60 years of age [n = 186] [HR = 1.00, 95% CI (0.58, 1.72)] and ≥ 65 years of age [n = 122] [HR = 1.01, 95% CI (0.53, 1.94)]) and patients with no extranodal sites (n = 445) (HR = 1.04, 95% CI [0.67, 1.62]) showed no clinically meaningful difference between the two arms.
Maltese: L-effikaċja fil-popolazzjoni tal-pazjenti anzjani (pazjenti bl-età ta' ≥ 60 sena [n = 186] [HR = 1.00, 95% CI (0.58, 1.72)] u l-età ta' ≥ 65 sena [n = 122] [HR = 1.01, 95% CI (0.53, 1.94)]) u pazjenti bl-ebda siti estranodali (n = 445) (HR = 1.04, 95% CI [0.67, 1.62]) ma wriet l-ebda differenza klinika sinifikanti bejn iż-żewġ fergħat.
English: Reconstituted vial concentration (5 mg/ml)
Maltese: Konċentrazzjoni tal-kunjett rikostitwit (5 mg/mL)
English: 33 years (18-71)
Maltese: 33 sena (18-71)
English: Represents pooling of preferred terms.
Maltese: Jirrappreżentaw ġabra ta' termini ppreferuti.
English: Figure 5: Kaplan-Meier Plot of OS
Maltese: Kaplan-Meier Plot ta' OS
English: Delpharm Novara S.r.l.
Maltese: Delpharm Novara S.r.l. Via Crosa, 86
English: Grade 3 neutropenia was reported in 13% and Grade 4 neutropenia was reported in 5% of patients.
Maltese: Newtropenija ta' Grad 3 ġiet irrappurtata fi 13%, u newtropenija ta' Grad 4 ġiet irrappurtata f'5% tal-pazjenti.
English: Cough, dyspnoea
Maltese: Sogħla, dispnea
English: John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in ADCETRIS-treated patients.
Maltese: Attivazzjoni mill-ġdid tal-virus John Cunningham (JCV) li twassal għal lewkoenċefalopatija multifokali progressiva (PML) u mewt tista' sseħħ f'pazjenti kkurati b'ADCETRIS.