FrancophonIA/ELRC3.0 huggingface dataset:
English: The opioid therapy must be provided by healthcare professionals trained in the use of anaesthetic medicinal products and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation.
Maltese: It-terapija bl-opjojdi għandha tkun ipprovduta minn professjonisti tal-kura tas-saħħa mħarrġa fl-użu ta' prodotti mediċinali anestetiċi u l-immaniġġjar tal-effetti respiratorji ta' opjojdi potenti, speċifikament stabbiliment u manutenzjoni ta' passaġġ tan-nifs miftuħ u ventilazzjoni assistita.
English: This risk is increased with the concomitant abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.
Maltese: Dan ir-riskju jiżdied bl-abbuż ta' buprenorphine flimkien ma' alkoħol u sustanzi oħra, speċjalment benzodiazepines.
English: Follow steps 15 and 16 for the removal of the remaining implants through the same incision.
Maltese: Segwi passi 15 u 16 għat-tneħħija tal-impjanti li jifdal permezz talistess inċiżjoni.
English: • pain affecting muscles and skeleton, neck, limbs, joints
Maltese: • spażmi tal-muskoli, skumdità fir-riġlejn u d-dirgħajn
English: Step 10: Verify the presence of each implant (26.5 mm in length) by palpation of the patient's arm immediately after the insertion, as shown in Figure 14.
Maltese: Ivverifika l-preżenza ta' kull impjant (tul ta' 26.5 mm) billi tgħafas id-driegħ talpazjent bil-mod immedjatament wara t-tqegħid, kif muri fil-Figura 14.
English: This summary was last updated on 03/09/2012.
Maltese: Dan is-sommarju ġie aġġornat fit-03/09/2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BTVPUR AlSap 8 on 17 March 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal BTVPUR AlSap 8 fis-17 ta' Marzu 2009.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Maltese: Il-vaċċin fih ukoll ‘aġġuvanti' (idrossidu tal-aluminju u saponin) biex itejjeb ir-rispons immunitarju.
English: BTVPUR AlSap 8 contains bluetongue virus of one type (‘serotype 8').
Maltese: BTVPUR AlSap 8 fih vajrus tal-lingwablu ta' tip wieħed (‘serotip 8').
English: The effects of maternally derived antibodies were investigated and the vaccine was shown to be effective in animals from 2.5 months of age.
Maltese: L-effetti ta' antikorpi li ġejjin millomm kienu investigati u ntwera li l-vaċċin kien effikaċi f'annimali li għandhom minn 2.5 xhur 'il fuq.
English: Animals may show a temporary increase in body temperature, usually of no more than 1°C, in the 24 hours after vaccination.
Maltese: Fl-24 siegħa ta' wara t-tilqima, l-annimali jista' jkollhom żieda temporanja fit-temperatura tal-ġisem, normalment ta' mhux aktar minn 1ºC.
English: BTVPUR AlSap 8 is used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: BTVPUR AlSap 8 jintuża fin-nagħaġ u f'bovini biex jipproteġihom kontra l-marda tal-lingwablu, li hija infezzjoni kkawżata mill-vajrus tal-lingwablu trażmess mill-insetti dipteri.
English: The studies showed that the vaccine is safe for sheep and cattle and that it prevents viraemia and reduces the signs of the disease in animals from one month of age that are infected with bluetongue virus serotype 8.
Maltese: L-istudji wrew li l-vaċċin huwa sigur għan-nagħaġ u l-bovini u li dan jipprevjeni l-viremija u jnaqqas issinjali tal-marda f'annimali li għandhom minn xahar 'il fuq li jkunu infettati mis-serotip 8 tal-vajrus tallingwablu.
English: In 2012 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR AlSap 8 to convert to normal.
Maltese: Fl-2012 is-CVMP qies li d-dejta mressqa kienet adegwata sabiex l-awtorizzazzjoni ta' BTVPUR AlSap 8 ssir normali.
English: The safety of the vaccine was studied in a number of laboratory safety studies carried out with BTVPUR AlSap in sheep and cattle using a high dose of the vaccine in animals of the minimum age.
Maltese: Ġew ippreżentati wkoll riżultati minn sensiela ta' provi ta' sigurtà fil-laboratorji mwettqa b'vaċċini ta' kompożizzjoni simili iżda b'serotipi differenti tal-lingwablu sabiex jiġu estrapolati konklużjonijiet dwar is-sigurtà, minħabba li għall-ewwel il-vaċċin kien tfassal biex jintuża f'każ ta' emerġenza.
English: BTVPUR AlSap 8 is a vaccine.
Maltese: BTVPUR AlSap 8 huwa vaċċin.
English: Inactivated vaccine against bluetongue disease virus, serotype 8
Maltese: Vaċċin inattivat kontra s-serotip 8 tal-marda tal-vajrus tal-lingwablu (bluetongue)
English: What is BTVPUR AlSap 8?
Maltese: X'inhu BTVPUR AlSap 8?
English: The duration of protection was also investigated in studies using sheep and cattle and was found to be 12 months for both species.
Maltese: It-tul ta' żmien tal-protezzjoni kien investigat ukoll fi studji bl-użu ta' nagħaġ u bovini, u nstab li dan idum 12-il xahar għaż-żewġ speċi.
English: The CVMP considered that the benefits of BTVPUR AlSap 8 are greater than the risks and recommended that it be given a marketing authorisation.
Maltese: Is-CVMP ikkunsidra li l-benefiċċji ta' BTVPUR AlSap 8 huma akbar mir-riskji u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: BTVPUR AlSap 8 was initially authorised under ‘exceptional circumstances'.
Maltese: Għall-ewwel BTVPUR AlSap 8 ġie awtorizzat taħt ‘ċirkostanzi eċċezzjonali'.
English: BTVPUR AlSap 8 is a vaccinethat is available as a suspension for injection.
Maltese: BTVPUR AlSap 8 huwa vaċċin li jiġi f'sospensjoni għal inezzjoni.
English: What is the risk associated with BTVPUR AlSap 8?
Maltese: X'riskji huma assoċjati ma' BTVPUR AlSap 8?
English: Results from a series of laboratory safety trials performed with vaccines of similar composition but of different bluetongue serotypes were also presented in order to extrapolate safety conclusions, as the vaccine was initially intended for use in an emergency situation.
Maltese: Studju ieħor fil-laboratorju stħarreġ l-użu tal-vaċċin fin-nagħaġ ta' bejn tlieta u erba' xhur.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease caused by bluetongue virus serotype 8.
Maltese: Il-vaċċin jintuża biex jimpedixxi l-viremija (il-preżenza ta' vajrusis fid-demm) u jnaqqas is-sinjali tal-marda kkważati millvajrus tas-serotip 8 tal-lingwablu.
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Leflunomide ratiopharm with a physician educational pack containing the following:
Maltese: L-Istati Membri għandhom jiżguraw li d-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ser jipprovdi lit-tobba li huma mistennija li jippreskrivu/jużaw Leflunomide ratiopharm b'pakkett edukattiv għat-tabib li jkun fih dan li ġej:
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of raised ALT.
Maltese: L-informazzjoni mogħtija fil-Fuljett ta' Tagħrif għall-Ispeċjalista għandha tagħti informazzjoni dwar it-tnaqqis fid-doża, it-twaqqif tal-kura u proċeduri ta' “wash-out” fil-każ ta' żieda flALT.
English: Tumour size ≤2 cm >2 cm
Maltese: Daqs tat-tumur ≤2 cm >2 cm
English: C/Bobinadora 1-5 Planta 1a Local 13 Mataro, 08302
Maltese: SUN Pharmaceuticals Spain S.L. C/Bobinadora 1-5 Planta 1a Local 13 Mataro, 08302
English: Grade 3
Maltese: grad 3
English: ≥35 years
Maltese: ≥35 snin
English: Age category 2 <35 years
Maltese: Kategorija ta' età 2 <35 snin
English: Age category 1 <50 years
Maltese: Kategorija ta' età 1 <50 snin
English: (see sections 4.4 and 4.8).
Maltese: (ara sezzjoni 4.8).
English: A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Maltese: Minoranza ta' pazjenti kienu ttestjati bl-użu ta' fluorescence in-situ hybridization (FISH).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 May 2010
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 10 mejju 2010
English: Statistical analysis
Maltese: Statistika
English: 5-fluorouracil (clinically important treatment related adverse events are presented).
Maltese: 5-fluorouracil (effetti avversi klinikament importanti relatati mal-kura huma rrappurtati).
English: Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.
Maltese: Acute respiratory distress syndrome, pulmonite tal-interstizjum u fibrożi tal-pulmuni kienu rarament irrappurtati.
English: *un-adjusted log-rank test
Maltese: *Unstratified logrank test
English: Solvent: Polysorbate 80 and ethanol, anhydrous
Maltese: Polysorbate 80 u ethanol, anhydrous
English: Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Maltese: Stratified log rank test *Threshold for statistical significance=0.0175 **PSA:
English: This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Maltese: ta' 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
English: Docetaxel plus trastuzumab1 n=92
Maltese: Docetaxel flimkien ma' trastuzumab1 n = 92
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor
Maltese: TAC = docetaxel, doxorubicin u cyclophosphamide FAC = 5-fluorouracil, doxorubicin u cyclophospamide CI = confidence interval; RE = riċettur tal-estroġenu
English: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Maltese: Prednisone jew prednisolone 5 mg orali darbtejn kuljum li tingħata kontinwament (ara sezzjoni 5.1).
English: The ORR was 59.3% (95%CI : 52.8 - 65.9) in AT arm versus 46.5% (95%CI : 39.8 - 53.2) in AC arm.
Maltese: Ir-RTTR kienet 59.3% (95% CI : 52.8 -65.9) fil-parti tal-istudju dwar AT versu 46.5% (95% CI : 39.8 -53.2) fil-parti tal-istudju dwar AC.
English: ≥50 years
Maltese: ≥50 snin
English: The Netherlands.
Maltese: The Netherlands tel.
English: Docefrez contains the active substance docetaxel.
Maltese: - Is-sustanza attiva hi docetaxel.
English: Grade 2
Maltese: grad 4
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Maltese: Ilpazjenti kkurati bit-TAC kellhom tnaqqis ta' 32 % fir-riskju ta' rikaduta meta mqabbel ma' dawk ikkurati bil-FAC (proporzjon ta' riskju = 0.68, 95% CI (0.49-0.93), p = 0.01).
English: Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Maltese: Docetaxel użat flimkien ma' doxorubicin u cyclophosphamide: terapija addizzjonali
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi ara sezzjoni 6.1.
English: Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Maltese: Docetaxel hu mmetabolizzat minn CYP3A4 u l-prednisone hu magħruf li jinduċi CYP3A4.
English: • headache* , insomnia*
Maltese: • qtugħ ta' nifs; sogħla*
English: A hazard ratio of less than 1 favors Docetaxel +Cisplatin+5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Maltese: Proporzjon ta' riskju ta' anqas minn 1 hu favur docetaxel + cisplatin +5-FU *Cox model (aġġustament għas-sit tat-tumur Primarju, T u N stadji kliniċi u PSWHO) **Logrank test ***Chi-square test
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs. 29.7% (docetaxel alone); p = 0.0058.
Maltese: 41.6% (docetaxel + capecitabine) kontra 29.7% (docetaxel wa ħdu); p = 0.0058.
English: MedDRA system organ classes
Maltese: Sistema tal-klassifika tal-organi fid-database MedDRA
English: Excipients: the solvent contains 35.4% (w/w) ethanol.
Maltese: Sustanzi mhux attivi: is-solvent fih 35.4% (w/w) ethanol.
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Maltese: Koagulazzjoni intravaskulari mifruxa (DIC), spiss assoċjata ma' sepsis u insuffiċjenza ta' organi multipli, kienet irrappurtata.
English: Hazard ratio*
Maltese: Ilproporzjo n tar-riskju*
English: Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Maltese: Okkorrenzi rari ta' deidrazzjoni bħala konsegwenza ta' avvenimenti gastrointestinali, perforament gastro-intestinali, kolite iskemika, kolite u enterokolite newtropenika kienu rrappurtati.
English: Musculoskeletal and connective tissue
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue
English: Amenorrhoea (G3/4: NA)
Maltese: Amenorreja (G3/4:NA)
English: Docetaxel is more than 95% bound to plasma proteins.
Maltese: Docetaxel hu iktar minn 95% marbut mal-proteini tal-plażma.
English: 4.1.3 Inject the entire contents of the syringe into the corresponding Docefrez vial.
Maltese: 4.1.3 Injetta l-kontenut sħiħ tas-siringa fil-kunjett korrispondenti ta' Docefrez.
English: Docetaxel is highly protein bound (>95%).
Maltese: Docetaxel hu marbut ħafna mal-proteina (> 95%).
English: The recommended dose of docetaxel is 75 mg/m2.
Maltese: Id-doża rrakomandata ta' docetaxel hi 75 mg/m2.
English: Anorexia (G3/4: 1%); Decreased appetite
Maltese: Anoreksja (G3/4: 1%); Nuqqas t'aptit
English: Arrhythmia (G3/4: 1.0%).
Maltese: Arritmija (G3/4: 1.0%).
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Maltese: Insuffiċjenza tal-qalb sintomatika kienet irrappurtata fi 2.2% tal-pazjenti li ħadu Docetaxel flimkien ma' trastuzumab meta mqabbel ma' 0% tal-pazjenti li ngħataw Docetaxel waħdu.
English: Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805) Without primary G-CSF prophylaxis (n = 111) n (%)
Maltese: G-CSF u mingħajr prevenzjoni primarja (GEICAM 9805) Mingħajr prevenzjoni primarja G-CSF (n = 111) n (%)
English: Each pack contains: 1 powder vial and 1 solvent vial.
Maltese: Kull pakkett fih: 1 kunjett bit-trab u 1 kunjett bis-solvent.
English: Radiation recall phenomena have rarely been reported.
Maltese: Recall phenomena tar-radjazzjoni kienu rarament irrappurtati.
English: Gastrointestinal pain (G3/4: 1.2%);
Maltese: Uġigħ gastrointestinali (G3/4: 1.2%);
English: Neoplasms benign, malignant and unspecified
Maltese: Neoplazmi beninni, malinni u mhux specifici
English: Gastrointestinal haemorrhage (G3/4:
Maltese: Emorraġija gastrointestinali (G3/4:
English: • change or absence of menstrual period*
Maltese: • tibdil jew assenza tal-mestrwazzjoni (period)*
English: Arrhythmia (G3/4:0.7%) Cardiac failure Hypotension;
Maltese: Arritmija (G3/4: 0.7%) Insuffiċjenza kardijaka
English: Docetaxel every 3 weeks
Maltese: Docetaxel kull 3
English: Hypertension;
Maltese: Letarġija;
English: Docetaxel increased response rate (33% vs. 12%, p<0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p=0.0004) and prolonged overall survival (11 months vs. 9 months, p=0.01).
Maltese: Docetaxel żied ir-rata tar-rispons (33% vs 12%, p < 0.0001), ittardja l-avvanz tat-tumur (19-il ġimgħa vs 11-il ġimgħa, p = 0.0004) u tawwal iż-żmien totali tas-sopravivenza (11-il xahar vs 9 xhur, p = 0.01).
English: Myocardial ischemia (G3/4: 1.7%)
Maltese: Iskemija mijokardijaka (G3/4: 1.7%)
English: • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Maltese: • 332 pazjent li ħadu docetaxel flimkien ma' prednisone jew prednisolone (effetti avversi klinikament importanti relatati mal-kura huma rrappurtati).
English: Lactation:
Maltese: Doża rrakkomandata:
English: Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Maltese: Każijiet rari ħafna ta' lupus erythematosus tal-ġilda u nfafet kbar bħal erythema multiforme, is-sindrome ta' Stevens-Johnson, u toxic epidermal necrolysis, kienu ġew irrappurtati b'docetaxel.
English: There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Maltese: Kien hemm żieda fl-inċidenza ta' SAEs (40% kontra 31%) u Grad 4 AEs (34% kontra 23%) fil-parti tal-istudju dwar dawk li ħadu ż-żewġ sustanzi meta mqabbla ma' dawk li ħadu docetaxel waħdu.
English: CF n=224
Maltese: n = 224
English: A
Maltese: u
English: The median TTP was 37.3 weeks (95%CI : 33.4 - 42.1) in AT arm and 31.9 weeks (95%CI : 27.4 - 36.0) in AC arm.
Maltese: Iż-ŻTP medjan kien 37.3 ġimgħat (95% CI : 34.4 --42.1) fil-parti tal-istudju dwar AT u 31.9 ġimgħat (95% CI : 27.4 -36.0) fil-parti tal-istudju dwar AC.
English: Docetaxel 75 mg/m² in combination with capecitabine
Maltese: Docetaxel 75 mg/m2 użat flimkien ma' capecitabine
English: Anorexia (G3/4: 11.7%).
Maltese: Anoreksja (G3/4: 11.7%).
English: Number.
Maltese: tel.
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Maltese: G3/4 Żieda fl-AST G3/4 Żieda ta' alkaline phosphatase fid-demm
English: Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin.
Maltese: Data limitata minn studju wieħed mhux ikkontrollat, issuġġerixxa xi interazzjoni bejn docetaxel u carboplatin.
English: Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%)
Maltese: Disġewżja (G3/4: < 1%); Parasteżija (G3/4: < 1%)
English: Frequencies are defined as: 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); not known (cannot be estimated from the available data)
Maltese: 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Dehydration and pulmonary oedema have rarely been reported.
Maltese: Id-deidrazzjoni u l-edema pulmonari kienu rarament irrappurtati.
English: 2 BEFORE YOU USE DOCEFREZ
Maltese: 2. QABEL MA TUŻA DOCEFREZ
English: The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Maltese: L-aħħar stadju sekondarju, PFS, wera tnaqqis tar-riskju mingħajr avvanz u mortalità ta' 29% u titjib ta' 22 xhur tal-medjan PFS (35.5 xhur għal TPF u 13.1 ta' PF).
English: Acute leukaemia / Myelodysplastic syndrome
Maltese: Sindrome ta' Lewkimja akuta/Majilodisplastik.
English: The reconstituted solution contains ~ 24 mg/ml docetaxel, corresponding with an extractable volume of approximately 20 mg/0.84 ml and 80 mg/3.36 ml.
Maltese: Is-soluzzjoni rrikostitwita fiha madwar 24 mg/ml ta' docetaxel, li tikkorrispondi ma' volum li jista' jinġibed ta' madwar 20 mg/0.84 ml u 80 mg/3.36 ml.
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Maltese: Stomatite (G3/4: 1.7%); Rimettar (G3/4: 0.8%); Dijarea (G3/4: 1.7%);
English: Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Maltese: waqt li 15-il pazjent fuq id-doxorubicin (9%) waqqfu l-kura minħabba tossiċità kardijaka (tliet każijiet fatali ta' insuffiċjenza konġestiva tal-qalb).
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Maltese: induċiex mutaġeniċità fit-test ta' Ames jew fi studju mutaġeniku tal-ġene CHO/HGPRT.
English: total of 1006 patients with KPS≥60 were randomized to the following treatment groups:
Maltese: Total ta' 1006 pazjenti b'KPS ≥ 60 kienu mqassma mingħajr għażla fi gruppi ta' kura kif deskritt hawn taħt:
English: 1 vial of solvent
Maltese: 1 kunjett bit-trab 1 kunjett bis-solvent
English: Pain response rate (%)
Maltese: Stima ta sentejn (%)
English: p-value
Maltese: p-valur
English: All patients who did not have progressive disease were to receive CRT as per protocol (PF/CRT).
Maltese: ingħataw (CRT), skont il-protokol (PF/CRT).
English: At a median follow-up time of 77 months, acute leukaemia occurred in 1 of 532 (0.2%) patients who received docetaxel, doxorubicin, and cyclophosphamide in the GEICAM 9805 study.
Maltese: Fi żmien medjan ta' 77 xahar waqt il-perijodu ta' osservazzjoni wara t-trattament, lewkimja akuta seħħet f'pazjent 1 minn 532 pazjent (0.2 %) li rċevew docetaxel, doxorubicin u cyclophosphamide flistudju GEICAM 9805.
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Maltese: Ir-reazzjonijiet avversi rrappurtati komuni ta' docetaxel innifsu huma: newtropenija (li kienet riversibbli u mhux kumulattiva: il-jum medjan biex jintlaħaq in-nadir kien ta' 7t ijiem u ż-żmien medju ta' dewmien tan-newtropenija severa (< 500 ċelluli/mm3) kien ta' 7t ijiem), anemija, alopeċja, dardir, rimettar, stomatite, dijarea u astenja.
English: G3/4 AST increased G3/4 ALT increased
Maltese: G3/4 Żieda fl-AST G3/4 Żieda fl-ALT
English: The solvent contains 35.4% w/w ethanol and polysorbate 80.
Maltese: Is-solvent fih 35.4% w/w ethanol u polysorbate 80.
English: Overall survival at 5 years was also significantly increased with TAC compared to FAC (87% versus 81%, respectively) i.e. an absolute reduction of the risk of death by 6% (p=0.008).
Maltese: Sopravivenza totali wara 5 snin kienet kibret b'mod sinifikattiv b'TAC meta mqabbla ma' FAC (87% kontra 81% rispetivament) li tfisser riskju assolut tal-mewt imnaqqas b'6% (p = 0.008).
English: G3/4 Blood alkaline phosphatase increased
Maltese: G3/4 Żieda ta' alkaline phosphatase fid-demm
English: • 1312 and 121 patients who received 100 mg/ m2 and 75 mg/m2 of docetaxel as a single agent respectively.
Maltese: • 1312 u 121 pazjent li ħadu 100 mg/m2 u 75 mg/m2 ta' docetaxel bħala mediċina ewlenija, rispettivament.
English: Alopecia (G3/4:
Maltese: Alopeċja (G3/4:
English: Uncommon adverse organ classes adverse reactions reactions reactions
Maltese: Reazzjonijiet avversi komuni hafna
English: Infection (G3/4: 3.6%) Neutropenic infection
Maltese: Infezzjoni (G3/4: 3.6%) Infezzjoni newtropenika
English: G3/4 Blood bilirubin increased (2.1%);
Maltese: G3/4 Żieda tal-bilirubina fid-demm (2.1%);
English: Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p=0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p=0.54), docetaxel increased response rate (52% vs. 37%, p=0.01) and shortened time to response (12 weeks vs. 23 weeks, p=0.007).
Maltese: Mingħajr ma affettwa ż-żmien totali tas-sopravivenza (għal docetaxel 15-il xahar kontra għal doxorubicin 14-il xahar, p = 0.38), jew iż-żmien sakemm javvanza t-tumur (b'docetaxel 27 ġimgħa kontra doxorubicin kien ta' 23 ġimgħa, p = 0.54), docetaxel wera rata ta' rispons aktar għolja (52% kontra 37%, p = 0.01) u qassar iż-żmien għar-rispons (12-il ġimgħa vs 23 ġimgħa, p = 0.007).
English: Stomatitis (G3/4: 7.8%); Diarrhoea (G3/4: 6.2%); Vomiting (G3/4: 5%); Constipation
Maltese: Stomatite (G3/4: 7.8%); Dijarea (G3/4: 6.2%); Rimettar (G3/4: 5%); Stitikezza
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Maltese: Stomatite (G3/4: 5.3%); Dijarea (G3/4: 4%);
English: No cases were reported in patients who received fluorouracil, doxorubicin and cyclophosphamide.
Maltese: Ebda każ ma ġie rrapportat f'pazjenti li rċevew fluorouracil, doxoruibicin u cyclophosphamide.
English: (incl cysts and polyps)
Maltese: (li jinkludu ċisti u polipi)