FrancophonIA/ELRC3.0 huggingface dataset:
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Maltese: Jista' jkun hemm il-bżonn li din id-doża tiżdied wara ġimgħa jew ġimagħtejn sa 45 mg darba kuljum jekk ikun meħtieġ kontroll aħjar tal-glukożju (zokkor) fid-demm.
English: Strength Pharmaceutical Form
Maltese: (ivvintat) Qawwa Għamla farmaċewtika
English: 6 Month 20191
Maltese: May 20191
English: EMA/PRAC/219990/2019
Maltese: EMA/PRAC/234265/2019 Corr2
English: Adopted at the 8-11 April 2019 PRAC
Maltese: Adottati fil-PRAC tat-8-11 ta' April 2019
English: Thromboembolic events occurred in 12% of patients randomized to rivaroxaban (4 ischaemic strokes and 3 myocardial infarctions).
Maltese: Seħħew avvenimenti tromboemboliċi fi 12 % tal-pazjenti randomizzati għal rivaroxaban (4 attakki iskemiċi u 3 infarti mijokardijaċi).
English: 59 patients were randomized to rivaroxaban 20 mg (15 mg for patients with creatinine clearance (CrCl) <50 mL/min) and 61 to warfarin (INR 2.0- 3.0).
Maltese: Is-segwitu medju kien ta' 569 jum. 59 pazjent ġew randomizzati għal rivaroxaban 20 mg (15 mg għal pazjenti bi tneħħija talkreatinina (CrCl) <50 mL/min) u 61 għal warfarin (INR 2.0- 3.0).
English: Modafinil - Evaluation of data on foetal outcomes including congenital anomalies from a single observational study in the US (EPITT no 19367)
Maltese: Modafinil - Evalwazzjoni tad-data dwar l-eżiti fetali inklużi l-anomaliji konġenitali minn studju ta' osservazzjoni wieħed fl-Istati Uniti (EPITT nru 19367)
English: As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see sections 4.4 and 4.5).
Maltese: Billi modafinil jista' jnaqqas leffettività ta' kontraċezzjoni orali, metodi addizzjonali alternattivi ta' kontraċezzjoni huma meħtieġa (ara sezzjonijiet 4.4 u 4.5)
English: In an investigator sponsored, randomized open-label multicenter study with blinded endpoint adjudication, rivaroxaban was compared to warfarin in patients with a history of thrombosis, diagnosed with antiphospholipid syndrome and at high risk for thromboembolic events (positive for all 3 antiphospholipid tests: lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).
Maltese: Fi studju tal-investigatur sponsorizzat, randomizzat, open-label, multiċentriku b'aġġudikazzjoni talpunt tat-tmiem blinded, rivaroxaban tqabbel ma' warfarin f'pazjenti bi storja ta' trombożi, dijanjostikati bis-sindrome antifosfolipid u f'riskju għoli għal avvenimenti tromboemboliċi (pożittivi għat-3 testijiet kollha ta' antifosfolipidi: antikoagulant ta' lupus, antikorpi ta' antikardjolipin u antikorpi ta' kontra lbeta 2-glikoproteina I).
English: Major bleeding occurred in 4 patients (7%) of the rivaroxaban group and 2 patients (3%) of the warfarin group.
Maltese: Fsada maġġuri seħħet f'4 pazjenti (7 %) tal-grupp ta' rivaroxaban u 2 pazjenti (3 %) tal-grupp ta' warfarin.
English: Selective serotonin reuptake inhibitors: citalopram; escitalopram - Drug interaction with fluconazole (EPITT no
Maltese: Inibituri selettivi ta' teħid mill-ġdid ta' serotonin: citalopram; escitalopram - Interazzjoni mediċinali bi fluconazole (EPITT nru 19327)
English: 4.5 Interaction with other medicinal products and other forms of interaction Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Għalhekk, għandha tiġi eżerċitata kawtela meta jintuża b'mod konkomitanti mal-inibituri ta' CYP2C19 (eż. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) jew cimetidine.
English: Direct acting Oral Anticoagulants (DOACs) including rivaroxaban/apixaban/edoxaban/dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Maltese: Orali b'azzjoni diretta (DOACs) inkluż2 rivaroxaban/apixaban/edoxaban/dabigatran etexilate mhumiex rakkomandati għal pazjenti bi storja ta' trombożi li huma dijanjostikati bis-sindrome antifosfolipid.
English: Direct-acting oral anticoagulants (DOACs): apixaban; dabigatran etexilate; edoxaban; rivaroxaban - Recurrent thrombosis in patients with antiphospholipid syndrome (EPITT no 19320)
Maltese: Antikoagulanti orali b'azzjoni diretta (DOACs): apixaban; dabigatran etexilate; edoxaban; rivaroxaban - Trombożi rikorrenti f'pazjenti b'sindrome antifosfolipid (EPITT nru
English: Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke).
Maltese: Cimetidine, lansoprazole u omeprazole (użati biex jikkuraw ulċeri fl-istonku), fluconazole (użat biex jikkura infezzjonijiet fungali), fluvoxamine (antidipressant) u ticlopidine (użat biex jitnaqqas ir-riskju ta' puplesija).
English: A reduction in the dose of [active substance] may be necessary based on monitoring of side-effects during concomitant treatment (see section 4.4).
Maltese: Tnaqqis fid-doża ta' [sustanza attiva] jista' jkun meħtieġ abbażi ta' monitoraġġ tal-effetti sekondarji matul il-kura konkomitanti (ara sezzjoni 4.4).
English: No events were reported in patients randomized to warfarin.
Maltese: Ma ġie rrappurtat l-ebda avveniment fil-pazjenti randomizzati għal warfarin.
English: Patients with high risk triple positive antiphospholipid syndrome
Maltese: Pazjenti b'sindrome antifosfolipid pożittiv triplu ta' riskju kbir
English: In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Maltese: B'mod partikolari għal pazjenti li huma tripli pożittivi (għal antikoagulanti ta' lupus, antikorpi ta' antikardjolipin u antikorpi ta' kontra l-beta 2-glikoproteina I), il-kura b'DOACs tista' tiġi assoċjata ma' rati miżjuda ta' avvenimenti trombotiċi rikorrenti meta mqabbla mat-terapija
English: Rivaroxaban 5.1.
Maltese: Sommarju tal-karatteristiċi tal-prodott 4.6.
English: Based on limited human experience from a pregnancy registry and spontaneous reporting modafinil is suspected to cause congenital malformations when administered during pregnancy.
Maltese: Abbażi ta' esperjenza fil-bniedem limitata minn reġistru tat-tqala u r-rappurtar spontanju, modafinil huwa suspettat li jikkawża malformazzjonijiet konġenitali meta jingħata waqt it-tqala.
English: a From the GETUG AFU15 study
Maltese: a Mill-istudju GETUG AFU15
English: Tumour size 2 cm >2 cm
Maltese: Daqs tat-tumur ≤2 cm
English: <50 years ≥50 years
Maltese: ≥50 years
English: Age category 2 <35 years ≥35 years
Maltese: Kategorija ta' età 2 <35 years
English: Grade 3
Maltese: Grad 2 Grad 3
English: Date of first authorisation: 27 November 1995 Date of latest renewal: 27 November 2005
Maltese: Data tal-aħħar tiġdid: 27 ta' Novembru 2005
English: STAMPEDE study
Maltese: Studju STAMPEDE
English: Hazard ratio (TAC/FAC)
Maltese: Proporzjon ta' riskju (TAC/FAC)
English: Ethanol anhydrous Citric acid
Maltese: Ethanol anidru Citric Acid
English: Age category 1 <50 years ≥50 years
Maltese: Kategorija ta' età 1 <50 years
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Germany
Maltese: Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main
English: Time to clinical progressionc
Maltese: Żmien sa progressjoni klinikac
English: CHAARTED study
Maltese: Studju CHAARTED
English: FORMULATION
Maltese: FORMULAZZJONI
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Maltese: Taxanes, Kodiċi ATC: L01CD 02
English: 2 ml (Fill 2.36 ml)
Maltese: 2 ml (volum attwali 2.36 ml)
English: a Time to event variables: Stratified log-rank test.
Maltese: Stratified log-rank test.
English: Acute leukaemia / Myelodysplastic syndrome.
Maltese: Lewkimja akuta/Sindrome ta' majilodisplastik.
English: Neutropenia (G3-4: 12 %) Anaemia
Maltese: Newtropenija (G3-4: 12 %) Anaemia
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Mhux applikabbli.
English: TAXOTERE contains ethanol (alcohol)
Maltese: TAXOTERE fih l-ethanol (alkoħol)
English: TAXOTERE vial: polysorbate 80, citric acid.
Maltese: Kunjett ta' TAXOTERE: polysorbate 80, citric acid.
English: Neutropenic infection (Grade 3-4)
Maltese: Infezzjoni newtropenika (Grad 3-4)
English: Response rate variables: Fisher's Exact test * p-value for descriptive purpose.
Maltese: Fisher's Exact test * p-value għal skop deskrittiv.
English: • 332 patients (TAX327) who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Maltese: • 332 pazjent (TAX327) li ħadu docetaxel flimkien ma' prednisone jew prednisolone (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: 0.5 ml (Fill 0.61 ml)
Maltese: INDIVIDWALI 0.5 ml (volum attwali 0.61 ml)
English: Alopecia (persisting:
Maltese: Alopeċja li tippersisti:
English: Myalgia (severe: 1.4%) Arthralgia
Maltese: Majalġja (severa 1.4%) Artralġja
English: A total of 790 male patients were allocated to the 2 treatment groups.
Maltese: Total ta' 790 pazjent raġel ġew allokati maż-żewġ gruppi ta' trattament.
English: Overall response rate (CR+PR) (%) p-value
Maltese: Ir-rata totali ta' rispons (CR+PR) (%) p-value
English: Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Maltese: 95% CI p-value* Stratified log rank test *Threshold for statistical significance=0.0175 **PSA:
English: Stomatitis/mucositis grade 4
Maltese: Stomatite/mukożite ta' grad 4
English: Stomatitis/mucositis grade 3
Maltese: Stomatite/mukożite ta' grad 3
English: PR = progesterone receptor a
Maltese: RP = riċettur tal-proġesteron a
English: Dizziness;
Maltese: Disgewżja;
English: TAXOTERE contains alcohol.
Maltese: TAXOTERE fih l-alkoħol.
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-fergħa AT versu 46.5% (95% CI : 39.8 - 53.2) fil-fergħa AC.
English: Hazard ratio: 1.032 [95% CI: 0.876; 1.216]
Maltese: Riskju Proporzjonali: 1.032 [95% CI: 0.876; 1.216]
English: TAXOTERE vials should be stored between 2°C and 25°C and protected from light.
Maltese: Il-kunjetti ta' TAXOTERE TAXOTERE għandhom jinħażnu bejn 2°C u 25°C u jkunu protetti mid dawl .
English: Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Maltese: jum (docetaxel + capecitabine) kontra 352 jum (docetaxel waħdu).
English: a
Maltese: L
English: Ethanol 95% Water for injections.
Maltese: Ethanol 95% Ilma għall-injezzjonijiet
English: TAXOTERE in combination with doxorubicin
Maltese: TAXOTERE użat flimkien ma' doxorubicin
English: (listed in section 6).
Maltese: (ara sezzjoni 6.6).
English: 4.1.3 Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
Maltese: 4.1.3 Injetta il-kontenut sħiħ tas-siringa fil-kunjett korrispondenti ta' TAXOTERE.
English: One vial contains 20 mg/0.5 ml docetaxel.
Maltese: Kunjett wieħed fih 20 mg/0.5 ml ta' docetaxel.
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: 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: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid.
Maltese: Eċċipjenti: polysorbate 80, ethanol anidru (ara l-fuljett għal aktar informazzjoni) u citric acid.
English: 1 vial of solvent for TAXOTERE
Maltese: TAXOTERE konċentrat SOLVENT għal TAXOTERE
English: Excipient with known effect: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Maltese: Kull kunjett ta' konċentrat fih 0.5 ml ta ethanol anidru (395 mg).
English: • ADT + docetaxel 75 mg/m² given at the beginning of ADT, administered every 3 weeks for 6 cycles
Maltese: • ADT + docetaxel 75 mg/m² mogħti fil-bidu ta' ADT, amministrat kull 3 ġimgħat għal 6 ċikli
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Maltese: Ir-reazzjonijiet avversi li jitqiesu possibbilment jew probabilment relatati mat-teħid ta' docetaxel inġabru minn:
English: • 545 patients (STAMPEDE study) who received docetaxel in combination with prednisone or prednisolone ADT.
Maltese: • 545 pazjent (studju STAMPEDE) li rċivew docetaxel flimkien ma' prednisone jew prednisolone u ADT.
English: (see sections 4.4 and 5.2).
Maltese: (ara sezzjoni 4.4).
English: The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta PSUR għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal mediċini.
English: Diarrhea (G3: 3%) Stomatitis (G3: 0%) Constipation (G3: 0%) Nausea (G3: 1%) Dyspepsia
Maltese: Dijarea (G3: 3%) Stomatite (G3: 0%) Stitikezza (G3: 0%) Nawsja (G3: 1%) Dispepsja
English: ER/PR-negative or Grade 3 or tumour size >5 cm
Maltese: RE/RP-negattiv jew Grad 3 jew daqs tat-tumur >5 cm
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
Maltese: Is-sindrome majilodisplastik ġie rrappurtat f'2 minn 744 pazjenti fuq TAC (0.3 %) u f'1 minn 736 pazjent fuq FAC (0.1 %).
English: Excipient with known effect: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Maltese: Kull kunjett ta' konċentrat fih 2 ml ta' ethanol anidru (1.58 g).
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = eostrogen receptor
Maltese: TAC = docetaxel, doxorubicin u cyclophosphamide FAC = 5-fluorouracil, doxorubicin u cyclophosphamide CI = confidence interval; RE = riċettur tal-estroġenu
English: EXP:
Maltese: Rimi:
English: PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Maltese: RP = riċettur tal-proġesteron a RE/RP-negattiv jew Grad 3 jew daqs tat-tumur >5 cm
English: Neutropenia (Grade 4)
Maltese: Newtropenja (Grad 4)
English: How to use TAXOTERE
Maltese: TA'TAXOTERE
English: 4.2 Preparation of the infusion solution
Maltese: 4.2 Preparazzjoni ta' l-infużjoni
English: Excipient with known effect: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Maltese: Kull kunjett ta' konċentrat fih 4 ml ta ethanol anidru (3.16 g).
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Maltese: L-aħjar rizultat sħiħ (CR + PR) bit-trattament studjat [kimoterapija +/- kimoradjuterapija] (%) (95%CI) ***p-value
English: Vascular disorders Venous thromboembolic events have rarely been reported.
Maltese: Ġrajjiet tromboemboliċi kienu rarament irrapportati.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali dilwit, ara sezzjoni 6.3. 6.5
English: 94.4 mg/2.36 ml).
Maltese: 489.7 mg/m2).
English: Discontinue treatment if these toxicities persist see section 4.4).
Maltese: It-trattament għandu jitwaqqaf jekk dawn l-effetti tossiċi jippersistu ara sezzjoni 4.4).
English: Metastatic hormone-sensitive prostate cancer STAMPEDE study
Maltese: Kanċer tal-prostata metastatiku sensittiv għall-ormon Studju STAMPEDE
English: Hypersensitivity (G3-4: 1%)
Maltese: Sensittività eċċessiva (G3-4: 1%)
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: kellhom tnaqqis ta' 32 % fir-riskju ta' rikaduta meta mqabbla ma' dawk ikkurati b'FAC (proporzjon ta' riskju = 0.68, 95% CI (0.49-0.93), p = 0.01).
English: Diarrhoea grade 4 First episode: reduce docetaxel and 5-FU doses by 20%.
Maltese: Dijarea ta' grad 4 L-ewwel episodju: naqqas id-dożi ta' docetaxel u 5-FU b'20%.
English: • one single-dose vial of solvent.
Maltese: • kunjett b'doża waħda ta' solvent .
English: Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat fih 20 mg docetaxel (bħala trihydrate).
English: A total of 1006 patients with KPS  60 were randomised to the following treatment groups:
Maltese: Total ta' 1006 pazjenti b'KPS ≥ 60 kienu mqassma mingħajr għażla fi gruppi ta' trattament kif deskritt hawn taħt:
English: Gastrointestinal haemorrhage (severe:
Maltese: emoraġija gastro intestinali (severa:
English: Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
Maltese: Ipofosfatimja (G3-4: 1%) Ipokalimja (G3: 0%)
English: SOLVENT for TAXOTERE
Maltese: SOLVENT TA'TAXOTERE
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 sustanza waħedha,
English: Anorexia (G3/4: 11.7%)
Maltese: Anorexja (G3/4: 11.7%)
English: Anorexia (G3/4:
Maltese: Anoreksja (G3/4:
English: Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment.
Maltese: Stevens-Johnson Syndrome), Nekroliżi Tossika tal-Epidermide (TEN, Toxic Epidermal Necrolysis) u Pustullożi Eksantematuża Akuta Mifruxa (AGEP, Acute Generalized Exanthematous Pustulosis):
English: G3/4 AST increased
Maltese: G3/4 Żieda fl-ALT
English: Histological grade Grade1 (includes grade not assessed) Grade 2
Maltese: Grad 1 (jinkludi meta ma ġiex valutat il-grad)
English: The name of this medicine is TAXOTERE.
Maltese: Mediċini oħra u TAXOTERE
English: Epistaxis (G3/4: < 1%)
Maltese: Parasteżija (G3/4: < 1%)
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 r-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,
English: • 1276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Maltese: 316 u GEICAM 9805 rispettivament) li ħadu docetaxel flimkien ma' doxorubicin u cyclophosphamide (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Maltese: Komuni ħafna: Tossiċità ematoloġika żdiedet f'pazjenti li ħadu trastuzumab u docetaxel, meta mqabbla ma' docetaxel waħdu (32% grad 3/4 newtropenija kontra 22%, meta ntużaw il-kriterji NCICTC).
English: Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Maltese: Is-sopravivenza kienet superjuri tal-fergħa fliemkien bit trattament ta' docetaxel + capecitabine flimkien (p = 0.0126).
English: Pharyngitis (G3: 0%)
Maltese: Farinġite (G3: 0%)
English: 13% (w/w) ethanol 95% in water for injections Fill: 7.33 ml
Maltese: 13% (w/w) t'ethanol 95% fl-ilma għall-injezzjonijiet Volum attwali: 7.33 ml
English: Anorexia (G3/4: 1.5%)
Maltese: Anoreksja (G3/4: 1.5%)
English: Thrombocytopenia (G4:
Maltese: Tromboċitopenija (G4:
English: The viscous solution contains 40 mg/ml docetaxel (anhydrous).
Maltese: Is-soluzzjoni magħquda fiha 40 mg/ml ta' docetaxel (anidru).
English: PSA response** at 12 months - N(%) p-valuea*
Maltese: Rispons ta' PSA ** wara 12-il xahar - N(%) p-valuea*
English: (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Maltese: b'riskju mnaqqas ta' mortalità ta' 22.7%.
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Maltese: Esofaġite/disfaġja/ odinofaġja (G3/4:
English: Gastrointestinal haemorrhage (G3/4:
Maltese: Emoraġija gastrointestinali (G3/4:
English: TAXOTERE 160 mg/8 ml sterile concentrate docetaxel
Maltese: TAXOTERE 160 mg/8 ml konċentrat sterili docetaxel
English: One vial contains 80 mg/2 ml docetaxel.
Maltese: Kunjett wieħed fih 80 mg/2 ml ta' docetaxel.
English: G3/4 Blood bilirubin increased (2.1%);
Maltese: G3/4 Żieda fil-bilirubin fid-demm (2.1%);
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Maltese: L-Effikaċja ta' docetaxel fit-trattament induttiv ta' pazjenti b'SCCHN inoperabbli u lokalment avvanzat (Analiżi bl-Iskop li Titratta)
English: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Maltese: It-tul ta' żmien medjan għal progressjoni kien ta' 186 jiem (docetaxel + capecitabine) kontra ta' 128
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-fergħa AT u 31.9 ġimgħat (95% CI: 27.4
English: • Docetaxel 75 mg/m every 3 weeks for 10 cycles.
Maltese: • Docetaxel 75 mg/m2 kull 3 ġimgħat għal 10 ċikli.
English: 13% (w/w) ethanol 95% in water for injections Fill: 1.98 ml
Maltese: 13% (w/w) t'ethanol 95% fl-ilma għall-injezzjonijiet Volum attwali: 1.98 ml
English: What TAXOTERE concentrate vial contains - The active substance is docetaxel (as trihydrate).
Maltese: X'fih il-kunjett ta' TAXOTERE konċentrat - Is-sustanza attiva hi docetaxel (bħala trihydrate).
English: What TAXOTERE contains - The active substance is docetaxel (as trihydrate).
Maltese: - Is-sustanza attiva hi docetaxel (bħala trihydrate).
English: Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
Maltese: Stitikezza (G3/4: 1.0 %); Ugigħ gastro-intestinali (G3/4:
English: Hypersensitivity (G3/4: 1.7%)
Maltese: Sensittività eċċessiva (G3/4: 1.7)
English: PSA response** at 6 months - N(%) p-valuea*
Maltese: Rispons ta' PSA ** wara 6 xhur - N(%) p-valuea*
English: VIAL LABEL / TAXOTERE 160 mg/8 ml
Maltese: TIKKETTA TAL-KUNJETT/ TAXOTERE 160 mg/8 ml
English: In patients who were 75 years of age or older, when compared to younger patients, neutropenia, anaemia, diarrhea, dyspnea and upper respiratory tract infection were reported with a greater incidence (at least 10% higher).
Maltese: F'pazjenti li kellhom 75 sena jew aktar, meta tqabblu ma' pazjenti iżgħar fl-età, newtropenija, anemija, dijarea, qtugħ ta' nifs, u infezzjoni fil-parti ta' fuq tal-apparat tan-nifs ġew irrappurtati b'inċidenza akbar (tal-inqas 10% aktar).
English: Lymphoedema
Maltese: FARMAĊEWTIKU
English: TAXOTERE 80 mg/4 ml sterile concentrate docetaxel
Maltese: TAXOTERE 80 mg/4 ml konċentrat sterili docetaxel
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Maltese: xhur, pazjenti kkurati b'TAC kellhom tnaqqis ta' 16.5% fir-riskju ta' rikaduta meta mqabbla ma dawk ikkurati b'FAC (proporzjon ta' periklu = 0.84, 95% CI (0.65-1.08), p=0.1646).
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Maltese: Dispneja (G3/4: 0.6%); Sogħla (G3/4: 0%)