FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Maltese: Pazjenti tal-fergħa kompettitiva rċevew cisplatin (P) 100 mg/m² bħala infużjoni fil-vini fuq tul ta' 30 minuta sa 3 sigħat f'jum 1, segwit minn 5-fluorouracil (F) 1000 mg/m² kuljum bħala infużjoni kontinwa minn jum 1 sa jum 5.
English: In GEICAM 9805 study, amenorrhoea persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, amenorrea ppersistiet waqt il-perjodu ta' osservazzjoni (medjan ta' żmien ta' osservazzjoni ta' 10 snin u 5 xhur) u ġie osservat li kienet baqgħet għaddejja fi 18 il pazjent (3.4 %) filfergħa ta' TAC u 5 pazjenti (1.0 %) fil-fergħa ta' FAC.
English: In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥ 1.5 times the ULN associated with alkaline phosphatase ≥ 2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Maltese: F'numru żgħir ta' pazjenti (n=3) li kellhom data bijokimiku kliniku suġġestiv ta' indeboliment tal-fwied minn grad ħafif sa moderat , (ALT, AST ≥ 1.5 drabi tal-OLN assoċjat ma' livelli tal-enzima alkaline phosphatase ≥ 2.5 drabi tal-OLN), it-tneħħija totali tbaxxiet b'medja ta' 27% (ara sezzjoni 4.2).
English: Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
Maltese: Analiżi tas-sottogruppi meta wieħed jikkonsidra l-età, is-sess u r-razza tiffavorixxi konsistentement ilergħa TCF meta mqabbla mal-fergħa CF.
English: What Docetaxel Mylan 80 mg/4 ml is and what it is used for What you need to know before you use Docetaxel Mylan 80 mg/4 ml How to use Docetaxel Mylan 80 mg/4 ml Possible side effects
Maltese: X'għandek tkun taf qabel ma tieħu Docetaxel Mylan 80 mg/4 ml Kif għandek tuża Docetaxel Mylan 80 mg/4 ml Effetti sekondarji possibbli
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m².
Maltese: Jekk jinqalgħu episodji oħra sussegwenti ta' newtropenija b'komplikazzjonijiet, id-doża ta' docetaxel għandha tiġi mnaqqsa minn 60 għal 45 mg/m².
English: TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Maltese: (26.8-ne) TTP=iż-żmien għal progressjoni; “ne” jindika li ma setax ikun stmat jew li ma kienx għadu milħuq
English: Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Maltese: Il-pazjenti fil-fergħa TAC irċevew profilassi bl-antibijotiku ciprofloxacin 500 mg oralment, darbtejn kuljum, ghal 10 ijiem, mibdi f'jum 5 ta' kull ċikli, jew ekwivalenti.
English: Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
Maltese: Sopravivenza totali wara 10 snin kienet kibret b'mod sinifikattiv b'TAC meta mqabbla ma' FAC (76% kontra 69% rispetivament) li tfisser riskju assolut tal-mewt imnaqqas b'7% (p = 0.002).
English: Each box contains 1 or 5 vials.
Maltese: Kaxxa ta' kunjett 1 jew 5 kunjetti.
English: One vial contains 200 mg of docetaxel.
Maltese: Kull kunjett ta' 10 ml fih 200 mg docetaxel.
English: Infections (G3/4: 5%)
Maltese: Infezzjoni (G3/4: 5.7%)
English: Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-to-Treat Analysis)
Maltese: Analiżi ta' Sottosetts-Terapija Adjuvanti f'Pazjenti fi Studju tal-Kanċer tas-Sider negattiv għal glandoli (Analiżi maħsuba għal Kura)
English: What Docetaxel Mylan 200 mg/10 ml contains
Maltese: Kif jidher Docetaxel Mylan 200 mg/10 ml u l-kontenut tal-pakkett
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI Docetaxel Mylan 80 mg/4 ml konċentrat soluzzjoni għall-infużjoni docetaxel
English: MedDRA system organ Classes
Maltese: Sistema tal-klassifika tal-organi fid-Database MedDRA
English: Dyspnoea; Cough; Rhinorrhoea
Maltese: Mard bħall-influwenza; Uġigħ fis-sider; Riħ bid
English: Anaemia (G3/4: 3%); Neutropenia (G3/4:
Maltese: Newtropenija (G3/4: 63%); Anemija (G3/4: 10%)
English: Hypersensitivity (G3/4:0.6%)
Maltese: Sensittivita eċċessiva (G3/4: 0.6%)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg/10 ml
Maltese: INDIVIDWALI 200 mg/10 ml
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Disturbi fis-sistema nervuża
English: In GEICAM 9805 study, alopecia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, alopeċja ppersistiet waqt il-perjodu ta' osservazzjoni (medjan ta' żmien ta' osservazzjoni ta' 10 snin u 5 xhur) u ġie osservat li kienet baqgħet għaddejja f'49 pazjent (9.2 %) filfergħa ta' TAC u f'35 pazjent (6.7 %) fil-fergħa ta' FAC.
English: (G3/4: 1.2%)
Maltese: Edima (G3/4: 1.2%)
English: How to store Docetaxel Mylan 80 mg/4 ml
Maltese: X'fih Docetaxel Mylan 80 mg/4 ml
English: In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Maltese: Fil-pazjenti trattati b'docetaxel, doxorubicin u cyclophosphamide (TAC), ir-riskju li jiżviluppaw myelodysplasia jew lewkimija tat-tip myeloid tardivi, jirrikjedi l-immoniterjar ematoloġiku wara ttrattament.
English: This medicine contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial equivalent to 10 ml of beer or 4 ml wine per vial.
Maltese: Dan il-prodott mediċinali fih 50 vol % ta' ethanol (alkoħol), i.e sa 0.395 g kull kunjett, ekwivalenti għal 10 ml ta' birra jew 4 ml ta' inbid kull kunjett.
English: Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
Maltese: L-inċidenza tar-rikaduta hekk kif għaddew 10 snin tnaqqas fil-pazjenti li rċevew TAC meta mqabbel ma' dawk li rċevew FAC (39% kontra 45%, rispettivament) li tfisser riskju assolut imnaqqas b'6% (p = 0. 0043).
English: For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Maltese: Għall-każijiet ta' kanċer tas-sider, tal-istonku, tal-pulmun mhux mikroċitoma, u tar-ras u tal-għonq, ilpremedikazzjoni, b'corticosteroid orali bħal dexamethasone 16 mg kuljum (e.g. 8 mg BID) għal 3 ijiem, mibdija jum 1 qabel it-teħid ta' docetaxel, sakemm mhux kontraindikat, tista' tintuża (ara sezzjoni 4.4).
English: The recommended dose of docetaxel is 75 mg/m² as a 1-hour infusion, followed by cisplatin 75 mg/m², as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m² per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Maltese: Id-doża rakkomandata ta' docetaxel hija 75 mg/m² mogħtija bħala infużjoni tul siegħa, segwita minn cisplatin 75 mg/m², bħala infuzjoni tul ta' 1 sa 3 sigħat (it-tnejn fl-ewwel jum biss), segwita minn 5fluorouracil 750 mg/m²kuljum, mogħti bħala infużjoni kontinwa fuq medda ta' 24 siegħa għal 5 ijiem, mibdija fit-tmiem tal-infużjoni ta' cisplatin.
English: A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Maltese: It-total ta' 449 pazjenti kienu mqassma, mingħajr għażla, biex jirċievu jew docetaxel 100 mg/m² li tingħata bħala infużjoni tul siegha, jew paclitaxel 175 mg/m² bħala infużjoni tul ta' 3 sigħat.
English: Hearing impaired (G3/4: 0%)
Maltese: Disgewzja (G3/4: 0%)
English: A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Maltese: Analiżi aġġornata ta' sopravivenza, maħduma fuq osservazzjoni wara l-kura, fuq medda ta' żmien medjan ta' 41.6 xhur, ma baqgħetx turi differenza statistikament sinifikanti, iżda dejjem iffavorixiet ittip ta' trattament b'TCF, u wriet li l-benefiċċju ta' TCF fuq CF kien jidher sew bejn it-18 u t-30 xahar tal-perijodu ta' osservazzjoni wara l-kura.
English: Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Maltese: Lista f'tabella ta' reazzjonijiet avversi għal kanċer tal-prostata għal Docetaxel 75 mg/m² użat flimkien ma' prednisone jew prednisolone:
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Maltese: Lista f'tabella ta' reazzjonijiet avversi għal adenokarċinoma gastrika għal Docetaxel 75 mg/m² użat flimkien ma' cisplatin u 5-fluorouracil Sistema tal-klassifika tal-organi fidDatabase MedDRA
English: Metabolism and nutrition disorders Nervous system disorders
Maltese: Disturbi tal-metaboliżmu u nnutrizzjoni
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized to one of two arms.
Maltese: F'dan listudju, 501 pazjent li kellhom SCCHN inoperabbli u lokalment avvanzat u b'performance status ta'WHO ta' 0 jew 1, tqassmu lil waħda miż-żewġ friegħi tat-trattament mingħajr għażla.
English: How to store Docetaxel Mylan 20 mg/1 ml Contents of the pack and other information
Maltese: Kif taħżen Docetaxel Mylan 20 mg/1 ml Kontenut tal-pakkett u informazzjoni oħra
English: Docetaxel Mylan in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Maltese: Docetaxel Mylan flimkien ma' trastuzumab huwa indikat għat-trattament ta'pazjenti b'kanċer metastatiku tas-sider, liema tumuri jesprimu bil-qawwa HER2, u li preċedentement ma kinux ħadu kimoterapija għall-mard metastatiku.
English: How to store Docetaxel Mylan 200 mg/10 ml Contents of the pack and other information
Maltese: Kif taħżen Docetaxel Mylan 200 mg/ 10 ml Kontenut tal-pakkett u informazzjoni oħra
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomized to one of two treatment arms.
Maltese: F'dan l-istudju, 358 pazjent li kellhom SCCHN inoperabbli u lokalment avvanzat u b'performance status ta' WHO ta' 0 jew 1, tqassmu lil waħda miż-żewġ friegħi tattrattament mingħajr għażla.
English: One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Maltese: Kull kunjett ta' 1 ml ta' konċentrat fih 20 mg docetaxel.
English: For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Maltese: Għall-modifikazzjonijiet fid-dożi ta' cisplatin u 5-fluorouracil, ara s-sommarju tal-karatteristiċi talprodott li jikkorrispondi.
English: Nausea (G3/4: 0.6%); Stomatitis (G3/4: 4.0%);
Maltese: Letarġija (G3/4: 4.0%); Deni (G3/4: 3.6%);
English: One hundred eighty six patients were randomized to receive docetaxel (100 mg/m²) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Maltese: Mija sitta u tmenin (186) pazjent kienu mqassma mingħajr għażla biex jieħdu docetaxel (100 mg/m²) bi trastuzumab jew mingħajru; 60% tal-pazjenti rċevew preċedentement kimoterapija miżjuda b'tip ta' anthracycline.
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Maltese: In vivo, docetaxel jaħdem indipendentement mill-iskeda ta' kif jingħata u għandu firxa wiesgħa t'attivita fuq it-tumuri esperimentali, kontra tumuri mlaqqmin u avvanzati derivati millġrieden u mill-bnedmin.
English: 95% CI p-value*
Maltese: Il-proporzjon tar-riskju 95% CI valur p†*
English: How to store Docetaxel Mylan 20 mg/1 ml
Maltese: X'fih Docetaxel Mylan 20 mg/1 ml
English: One large randomized phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
Maltese: Dawn ingħataw doxorubicin (50 mg/m²) flimkien ma' docetaxel (75 mg/m²) (il-fergħa AT) kontra doxorubicin (60 mg/m²) flimkien ma' cyclophosphamide (600 mg/m²) (il-fergħa AC).
English: Gastrointestinal pain (G3/4: 1.2%);
Maltese: Disturbi gastrointestinali Stomatite (G3/4: 5.3%);
English: What Docetaxel Mylan 80 mg/4 ml contains
Maltese: Kif jidher Docetaxel Mylan 80 mg/4 ml u l-kontenut tal-pakkett
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m² and 113 l, respectively.
Maltese: Il-valuri medji tat-tneħħija totali mill-ġisem u l-volum ta' distribuzzjoni meta jintlaħaq stat stabbli u miżmum kienu 21 l/siegħa/m² u 1131l, rispettivament.
English: Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Maltese: Fġir l-imnieħer (G3/4: 0%); Dispneja (G3/4: 0.6%); Sogħla (G3/4: 0%)
English: In first-line treatment, docetaxel 75 mg/m² is given in combination therapy with doxorubicin (50 mg/m²).
Maltese: Meta jintuża għall-kura preferita, docetaxel 75 mg/m² jingħata flimkien ma' doxorubicin (50 mg/m²).
English: What Docetaxel Mylan 20 mg/1 ml is and what it is used for What you need to know before you use Docetaxel Mylan 20 mg/1 ml How to use Docetaxel Mylan 20 mg/1 ml Possible side effects
Maltese: X'għandek tkun taf qabel ma tieħu Docetaxel Mylan 20 mg/1 ml Kif għandek tuża Docetaxel Mylan 20 mg/1 ml Effetti sekondarji possibbli
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml
Maltese: INDIVIDWALI 20 mg/1 ml
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Maltese: Pazjenti tal-fergħa ta' docetaxel ingħataw docetaxel (T) 75 mg/m² bħala infużjoni fil-vini fl-ewwel jum segwit minn cisplatin (P) 100 mg/m² li jingħata bħala infużjoni fil-vini fuq tul ta' 30 minuta sa 3 sigħat, segwit minn 5-fluorouracil (F) 1000 mg/m² kuljum bħala infużjoni kontinwa minn jum 1 sa jum 4.
English: Asthenia (severe: Fluid retention (severe:
Maltese: emorraġija gastro intestinali (severa:
English: Nausea (G3/4: 4%);
Maltese: Dijarea (G3/4: 3.4%);
English: Docetaxel Mylan in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Maltese: Docetaxel Mylan flimkien ma' cisplatin u 5-fluorouracil huwa indikat fit-trattament ta' pazjenti li għandhom adenokarċinoma metastatika tal-istonku, li tinkludi l-adenokarċinoma tal-parti fejn l-istonku jingħaqad mal-esofagu, u li ma kinux ħadu l-kimoterapija qabel, għal mard metastatiku.
English: Constipation (G3/4:
Maltese: Konġuntivite (G3/4:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 200 mg/10 ml sterile concentrate docetaxel
Maltese: U MNEJN GĦANDU JINGĦATA Docetaxel Mylan 200 mg/10 ml konċentrat sterili docetaxel
English: This medicine contains 50 vol % ethanol (alcohol), i.e. up to 3.95g per vial equivalent to 100 ml of beer or 40 ml wine per vial.
Maltese: Dan il-prodott mediċinali fih 50 vol % ta' ethanol (alkoħol), i.e sa 3.95 g kull kunjett, ekwivalenti għal 100 ml ta' birra jew 40 ml ta' inbid kull kunjett.
English: In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m² immediately followed by cisplatin 75 mg/m² over 30-60 minutes.
Maltese: F'pazjenti li qatt ma ħadu l-kimoterapija qabel u li qed jiġu ikkurati għall-kanċer tal-pulmun mhux mikroċitoma, il-programm tad-dożi rakkomandati huwa docetaxel 75 mg/m² segwit immedjatament b'cisplatin 75 mg/m² fuq perjodu ta' bejn 30 u 60 minuta.
English: In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m² administered 1-hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Maltese: Fil-każ ta' trattament miżjud ta' kanċer operabbli tas-sider, pożittiv u negattiv għal glandoli, id-doża ta' docetaxel hija ta' 75 mg/m² li trid tingħata siegħa wara doxorubicin 50 mg/m² u cyclophosphamide 500 mg/m², kull 3 ġimgħat għal 6 ċikli (programm ta' kura b'TAC) (ara wkoll Aġġustamenti fid-doża waqt it-trattament).
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Maltese: - Jekk ikollok xi effett sekondarju kellem lit-tabib, lill-ispiżjar tal-isptar, jew lill-infermier tiegħek fl-isptar.
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Maltese: Sindromu ta' distress respiratorju akut u każijiet ta' pnewmonite/pnewmonja interstizjali, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja li kultant wasslu għal-mewt kienu rarament irrapportati.
English: Infections and infestations Blood and lymphatic system disorders
Maltese: Infezzjonijiet u infestazzjonijietet Disturbi fid-demm u fissistema limfatika
English: Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316).
Maltese: In-newropatija periferika tas-sensazzjoni kienet għadha innotata matul il-perijodu ta' osservazzjoni ta' wara t-trattament f'10 pazjenti minn 84 pazjent b'newropatija periferika tas-sensazzjoni li kienet hemm fit-tmiem tal-kimoterapija fl-istudju tal-kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX316).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml
Maltese: INDIVIDWALI 80 mg/4 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 20 mg/1 ml sterile concentrate docetaxel
Maltese: U MNEJN GĦANDU JINGĦATA Docetaxel Mylan 20 mg/1 ml konċentrat sterili docetaxel
English: Nausea (G3/4: 5%); Stomatitis (G3/4: 7.8%);
Maltese: Stomatite (G3/4: 1.7%); Rimettar (G3/4: 0.8%);
English: How to store Docetaxel Mylan 80 mg/4 ml Contents of the pack and other information
Maltese: Kif taħżen Docetaxel Mylan 80 mg/4 ml Kontenut tal-pakkett u informazzjoni oħra
English: Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
Maltese: Il-kwalità sħiħa tal-ħajja (QoL) u r-riżultati tal-benefiċċju kliniku konsistentement indikaw titjib favur ilfergħa ta' TCF.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 80 mg/4 ml sterile concentrate docetaxel
Maltese: U MNEJN GĦANDU JINGĦATA Docetaxel Mylan 80 mg / 4 ml konċentrat sterili docetaxel
English: G3/4 Blood bilirubin increased (< 2.5%);
Maltese: G3/4 Bilirubin fiddemm ogħla (<2.5%); G3/4
English: General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Fl-istudju TAX 316, l-edima periferika kienet għadha hemm matul il-perijodu ta' osservazzjoni ta' wara t-trattament fi 19-il pazjent minn 119 pazjent bl-edima periferika fil-fergħa tat-TAC u f'4 pazjenti minn 23 pazjent bl-edima periferika fil-fergħa tal-FAC.
English: What Docetaxel Mylan 200 mg/10 ml is and what it is used for What you need to know before you use Docetaxel Mylan 200 mg/10 ml How to use Docetaxel Mylan 200 mg/10 ml Possible side effects
Maltese: X'għandek tkun taf qabel ma tieħu Docetaxel Mylan 200 mg/10 ml Kif għandek tuża Docetaxel Mylan 200 mg/10ml Effetti sekondarji possibbli
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Maltese: Sindromu ta' distress respiratorju akut u każijiet ta' pnewmonite/pnewmonja interstizjali, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja li kultant wasslu għal mewt kienu rarament irrapportati.
English: Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion Docetaxel
Maltese: Docetaxel Mylan 200 mg/10 ml: kunjett wieħed fih 200 mg ta' docetaxel.
English: Vomiting (G3/4: 0.6%)
Maltese: Arritmija (G3/4: 0.6%)
English: Pyrexia (G3/4: 1%);
Maltese: Tqalligħ (G3/4: 5%);
English: Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Maltese: Docetaxel instab li huwa ċitotossiku in vitro għall-linji ċellulari ta' tumuri li huma derivati mill-ġrieden u l-bniedem, u kontra ċelluli umani meħudin minn tumuri hekk kif dawn ikunu tneħħew, fi studji klonoġeniċi fil-laboratorju.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI Docetaxel Mylan 200 mg/10 mg ta' konċentrat għal soluzzjoni għall-infużjoni. docetaxel
English: In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
Maltese: F'pazjenti li huma kkurati b'docataxel, flimkien ma' doxorubicin u cyclophospahamide (TAC) newtropena bid-deni u/jew infezzjoni newtropenika seħħew anqas ta' spiss meta pazjenti ħadu profilassi primarja b'G-CSF.
English: This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 3.95 g per vial, equivalent to 100 ml of beer or 40 ml wine per vial.
Maltese: Dan il-prodott mediċinali fih 50 vol % ta' ethanol (alkoħol),i.e sa 3.95 g kull kunjett, ekwivalenti għal 100 ml ta' birra jew 40 ml ta' inbid kull kunjett.
English: G3/4 Blood bilirubin increased (2.1%);
Maltese: G3/4 Bilirubin fiddemm ogħla (2.1%) G3/4
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Maltese: Tqalligħ (G3/4: 16%); Stomatite (G3/4: 23.7%); Rimettar (G3/4:
English: EXP: Read the leaflet for the shelf life of the diluted medicine.
Maltese: EXP: Aqra l-fuljett dwar liskadenza għall-prodott dilwit.
English: Gastrointestinal haemorrhage (G3/4:
Maltese: Sensittivita eċċessiva (G3/4:
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Maltese: Newtropenija (G3/4: 83.5%); Anemija (G3/4:12.4%);
English: Immune system disorders Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu unnutrizzjoni
English: Ischemia myocardial
Maltese: Deskwamazzjoni tal-ġilda