FrancophonIA/ELRC3.0 huggingface dataset:
English: This indicates potential adverse effects of steroid hormones in the environment.
Maltese: Dan jindika effetti avversi potenzjali tal-ormoni sterojdi fl-ambjent.
English: In parallel of the QSAR calculation, the applicant has considered the worst case where altrenogest is not metabolised at all.
Maltese: B'mod parallel mal-kalkolu tal-QSAR, l-applikant ikkunsidra l-agħar każ fejn altrenogest ma jiġi metabolizzat xejn.
English: The applicant argued that the environmental load of altrenogest is comparable to other hormones measured and provided public available literature regarding effect concentrations of different hormones in the low ng/l range, but none with altrenogest.
Maltese: L-applikant argumenta li t-tagħbija ambjentali ta' altrenogest hija paragunabbli ma' ormoni oħra mkejla u pprovda letteratura pubblikament disponibbli dwar il-konċentrazzjonijiet tal-effett ta' ormoni differenti fil-medda baxxa ta' ng/l, iżda ma pprovda xejn dwar altrenogest.
English: Using the total residue approach for intensively reared animals the PECsoil for pigs was determined to be 3.01 μg/kg and refining by means of FOCUS models led to values of 0.93 µg/kg for open systems and 0.36 µg/kg for closed systems.
Maltese: Bl-użu talapproċċ tar-residwu totali għall-annimali mrobbija b'mod intensiv, il-PECħamrija għall-majjali kienet stabbilita li hija 3.01 μg/kg u l-irfinar permezz ta' mudelli FOCUS wassal għal valuri ta' 0.93 µg/kg għal sistemi miftuħa u 0.36 µg/kg għal sistemi magħluqa.
English: In order to address the concerns raised by the referral, the applicant provided a Phase I ERA, references from public literature and a scientific justification why the ERA can stop at Phase I and the ‘however clause' should not be invoked.
Maltese: Sabiex jindirizza t-tħassib imqajjem mir-riferiment, l-applikant ipprovda ERA ta' Fażi I, referenzi milletteratura pubblika u ġustifikazzjoni xjentifika għaliex l-ERA tista' tieqaf fil-Fażi I u m'għandhiex tiġi invokata l-‘however clause'.
English: In this procedure, the Committee was asked to consider whether in the case of Suifertil 4 mg/ml Oral Solution for Pigs, containing as the active substance a synthetic hormone (altrenogest), the ‘however clause' should be applied and a tailored Phase II environmental risk assessment should be provided in
Maltese: F'din il-proċedura, il-Kumitat intalab jikkunsidra jekk fil-każ ta' Suifertil 4 mg/ml Soluzzjoni Orali għallMajjali, li bħala s-sustanza attiva fih ormon sintetiku (altrenogest), għandhiex tiġi applikata l-‘however clause' u għandhiex tiġi pprovduta valutazzjoni tar-riskju ambjentali ta' Fażi
English: It is included in veterinary medicinal products currently authorised in the European Union for gilts and mares for zootechnical purposes (oestrus synchronisation).
Maltese: Huwa inkluż fil-prodotti mediċinali veterinarji attwalment awtorizzati fl-Unjoni Ewropea għall-majjali nisa u d-dwieb għal skopijiet żootekniċi (sinkronizzazzjoni tas-saħna sesswali).
English: The efficacy of Suifertil has been demonstrated according to current rules during the decentralised procedure.
Maltese: L-effikaċja ta' Suifertil ġiet murija skont ir-regoli attwali matul ilproċedura diċentralizzata.
English: As there is no product specific concern identified for Suifertil 4 mg/ml Oral Solution for Pigs that is different from the other, already authorised altrenogest containing veterinary medicinal products, it is considered appropriate to await the outcome of the ongoing Article 35 referral before any different conclusions regarding the environmental risk assessment or specific measures would be envisaged for Suifertil 4 mg/ml Oral Solution for Pigs.
Maltese: Billi ma hemm l-ebda tħassib speċifiku għall-prodott, identifikat għal Suifertil 4 mg/ml Soluzzjoni Orali għall-Majjali, li huwa differenti mill-prodotti mediċinali veterinarji l-oħra diġà awtorizzati, li fihom altrenogest, huwa meqjus xieraq li wieħed jistenna r-riżultat tar-riferiment li għaddej skont l-Artikolu 35 qabel ma jiġu previsti xi konklużjonijiet differenti rigward il-valutazzjoni tar-riskju ambjentali jew miżuri speċifiċi għal Suifertil 4 mg/ml Soluzzjoni Orali għall-Majjali.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of Suifertil 4 mg/ml Oral Solution for Pigs due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the product.
Maltese: Dan ir-riferiment skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE sar minħabba tħassib li l-applikant ma kienx wera b'mod sodisfaċenti s-sigurtà ambjentali ta' Suifertil 4 mg/ml Soluzzjoni Orali għallMajjali minħabba nuqqas ta' dejta pivitali li mingħajrha mhuwiex possibbli li wieħed jikkonkludi dwar is-sigurtà ambjentali tal-prodott.
English: Surface water for altrenogest was modelled using FOCUS simulation models, using the two scenarios (open and closed models) with 0% and 80% metabolism each.
Maltese: L-ilma tal-wiċċ għal altrenogest ġie mmudellat bl-użu ta' mudelli ta' simulazzjoni FOCUS, li jużaw iżżewġ xenarji (mudelli miftuħa u magħluqa) b'0% u 80% metaboliżmu kull wieħed.
English: Effect data with altrenogest are not available in the public domain.
Maltese: Id-dejta dwar l-effett b'altrenogest mhix disponibbli fid-dominju pubbliku.
English: The concerns expressed by the objecting CMS in respect to the risk to aquatic organisms do not relate specifically to the product Suifertil 4 mg/ml Oral Solution for Pigs, but equally to all relevant veterinary medicinal products containing the active substance altrenogest.
Maltese: It-tħassib espress mill-SMK li kienu qegħdin joġġezzjonaw, rigward ir-riskju għall-organiżmi akkwatiċi, mhuwiex marbut speċifikament mal-prodott Suifertil 4 mg/ml Soluzzjoni Orali għall-Majjali, iżda blistess mod għall-prodotti mediċinali veterinarji rilevanti kollha li fihom is-sustanza attiva altrenogest.
English: Germany considered that the data provided are inadequate to conclude that altrenogest will not pose a risk to the environment and that a tailored Phase II ERA based on the so called ‘however clause' of VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I1 is necessary.
Maltese: II ibbażata fuq l-hekk imsejħa ‘however clause' tal-GL6 tal-VICH (Kooperazzjoni Internazzjonali dwar l-Armonizzazzjoni tal-Ħtiġiet Tekniċi għarReġistrazzjoni ta' Prodotti Veterinarji):
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from France.
Maltese: Wara li kkunsidra d-dejta ppreżentata, ilKumitat ikkonkluda kif ġej dwar il-kwistjonijiet imqajma fin-notifika li rċieva minn Franza.
English: Both values are less than the trigger value of 100 µg/kg.
Maltese: Iż-żewġ valuri huma aktar baxxi mill-valur ta' 100 µg/kg li jiskatta l-azzjoni.
English: The referenced ‘however clause' is a provision in the introduction section of VICH GL6 which states “Phase I also identifies VMPs that require a more extensive EIA under Phase II.
Maltese: Il‘however clause' msemmija hija dispożizzjoni fis-sezzjoni ta' introduzzjoni tal-GL6 tal-VICH li tgħid “Fażi I tidentifika wkoll prodotti mediċinali veterinarji li jeħtieġu VIA aktar estensiva taħt Fażi
English: A Phase I environmental risk assessment in compliance with the relevant guidelines was provided, which showed that the PECsoil value for pigs does not exceed the VICH threshold of 100 μg/kg.
Maltese: Kienet ipprovduta valutazzjoni tar-riskju ambjentali ta' Fażi I f'konformità mal-linji gwida rilevanti, li wriet li l-valur tal-PECħamrija għall-majjali ma jaqbiżx il-livell limitu tal-VICH ta' 100 μg/kg.
English: The active substance is included in veterinary medicinal products currently licensed in several countries in the European Union for use in gilts and mares for synchronisation of oestrus.
Maltese: Is-sustanza attiva hija inkluża fil-prodotti mediċinali veterinarji attwalment illiċenzjati f'diversi pajjiżi fl-Unjoni Ewropea għall-użu fil-majjali nisa u d-dwieb għas-sinkronizzazzjoni tas-saħna sesswali.
English: Within the ongoing Article 35 referral for all veterinary medicinal products containing altrenogest to be administered orally to pigs and horses, further ecotoxicity and environmental fate data are expected to be submitted.
Maltese: Fi ħdan ir-riferiment li għaddej skont l-Artikolu 35 għall-prodotti mediċinali veterinarji kollha li fihom altrenogest biex jingħataw b'mod orali lill-majjali u liż-żwiemel, hija mistennija li tiġi ppreżentata aktar dejta dwar l-ekotossiċità u d-destin ambjentali.
English: Immediate packaging
Maltese: Ippakkjar Kontenut Daqs talpakkett
English: EU Number
Maltese: Numru tal-UE Isem kummerċjali
English: • if you are or become dehydrated,
Maltese: Nasofarinġite,
English: • The active substance is capecitabine.
Maltese: • Is-sustanza attiva hi capecitabine.
English: Palmar-plantar erythrodysaesthesia syndrome**
Maltese: eritrodisasteżija palmariplantari**
English: Interrupt until resolved to grade 0-1
Maltese: Interrompi sakemm riżolta għal grad 0 - 1
English: 95 % CI
Maltese: CI ta' 95 %
English: The AUC0-∞ values in μg•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Maltese: Il-valuri ta' AUC0-∞ f' μg•h/ml kienu ta' 7.75, 7.24, 24.6, 2.03 u 36.3.
English: • certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
Maltese: • ċerti tipi ta' arritmiji (inklużi fibrillazzjoni ventrikulari, torsade de pointes, u bradikardija)
English: The AUC of FBAL increased with age (20 % increase in age results in a 15 % increase in the AUC of FBAL).
Maltese: AUC ta' FBAL żdiedet mal-età (20 % żieda fl-età tirriżulta f'żieda ta' 15 % fl-AUC ta' FBAL).
English: HFS (see section 4.4)
Maltese: HFS (ara sezzjoni 4.4)
English: XELOX/ XELOX+P/ XELOX+BV (EPP*: N = 967; ITT**: N = 1,017)
Maltese: ANALIŻI PRIMARJA XELOX/ XELOX+P/ XELOX+BV (EPP*: N = 967; ITT**: N = 1,017)
English: Cytochrome P450 2C9 (CYP2C9) substrates
Maltese: Sottostrati taċ-ċitokromu P-450 2C9 (CYP2C9)
English: Modified XELIRI + bevacizumab (ITT: N = 120)
Maltese: XELIRI modifikat + bevacizumab (ITT: N = 120)
English: DPD deficiency
Maltese: Defiċjenza ta' DPD
English: PRIMARY ANALYSIS
Maltese: ANALIŻI PRIMARJA
English: Hazard ratio 95 % CI P value
Maltese: Proporzjon ta' periklu CI ta' 95 % Valur p
English: 7.5 mg/kg intravenous 30 - 90 mins
Maltese: 7.5 mg/kg fil-vini 30 - 90 mins
English: LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040 Barcelona
Maltese: Zona Franca, Barcelona 08040 Barcelona
English: FOLFOX-4 (PPP*: N = 252; ITT**: N = 314)
Maltese: FOLFOX-4 (PPP*: N = 252;
English: FOLFOX-4 or FOLFOX-4 + Bevacizumab
Maltese: FOLFOX-4 jew FOLFOX-4 +
English: The AUC of 5-FU was 30 % - 35 % higher on day 14.
Maltese: LAUC ta' 5-FU kienet 30 %-35 % ogħla fl-14-il jum.
English: 5 mg/kg intravenous 30 - 90 mins
Maltese: 5 mg/kg fil-vini 30 - 90 mins
English: It may harm them,
Maltese: Qtugħ ta' nifs,
English: Pharmacare Premium Ltd HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000
Maltese: HHF 003, Hal Far Industrial Estate Birżebbuġa, BBG 3000
English: Date of latest renewal: 16 June 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Novembru 2012 Data tal-aħħar tiġdid: 16 ta' Gunju 2017
English: Ethnic factors
Maltese: Fatturi etniċi
English: The 5 year OS rate was 78 % for XELOX versus 74 % for 5-FU/LV.
Maltese: Irrata ta' OS ta' 5 snin kienet 78 % għal XELOX kontra 74 % għal 5-FU/LV.
English: FOLFOX-4/FOLFOX-4+P /FOLFOX-4+BV (EPP*: N = 937; ITT**: N = 1,017)
Maltese: FOLFOX-4/ FOLFOX-4+P /FOLFOX-4+BV (EPP*: N = 937;
English: XELOX or XELOX+ Bevacizumab
Maltese: XELOX jew XELOX+
English: ITT *PPP = per-protocol population; **ITT = intent-to-treat population.
Maltese: *PPP=popolazzjoni skont il-protokoll; **ITT= popolazzjoni b'intenzjoni li jiġu ttrattati.
English: In vitro human plasma studies have determined that capecitabine, 5'-DFCR, 5'-DFUR and 5-FU are 54 %, 10 %, 62 % and 10 % protein bound, mainly to albumin.
Maltese: Studji in vitro dwar il-plażma umana wrew li capecitabine, 5'-DFCR, 5'-DFUR u 5-FU huma 54 %, 10 %, 62 % u 10 % mwaħħla mal-proteini, prinċipalment mal-albumina.
English: Pack sizes: 28, 30, 56, 60, 84, 112 or 120 film-coated tablets.
Maltese: Daqsijiet tal-pakkett: 28, 30, 56, 60, 84, 112 jew 120 pillola miksijin b'rita.
English: Faecal excretion is minimal (2.6 %).
Maltese: Ittneħħija fil-ħmieġ hija minima (2.6 %).
English: For terms marked with a “+”, the frequency count was based on grade 3 - 4 ADRs.
Maltese: Għal termini mmarkati b'“+”, lgħadd tal-frekwenza kien ibbażat fuq ADRs ta' grad 3-4.
English: The median time to progression was 186 days (capecitabine + docetaxel) vs. 128 days (docetaxel alone).
Maltese: Iż żmien medju għall-progressjoni kien ta' 186 jum (capecitabine + docetaxel) vs. 128 jum (docetaxel waħdu).
English: Body surface area (m²)
Maltese: Erja tas-superfiċje tal-ġisem (m²)
English: (neuropathy),
Maltese: (newropatija),
English: Coumarin-derivative anticoagulants
Maltese: Antikoagulanti derivattivi ta' coumarin
English: The 3 year DFS rate was 71 % for XELOX versus 67 % for 5-FU/LV.
Maltese: Ir-rata ta' DFS ta' 3 snin kienet 71 % għal XELOX kontra 67 % għal 5-FU/LV.
English: Capecitabine is activated via several enzymatic steps (see section 5.2).
Maltese: diversi passi enżimatiċi (ara sezzjoni 5.2).
English: • inflammation of the veins (thrombophlebitis)
Maltese: • infjammazzjoni tal-vini (tromboflebite)
English: cisplatin, irinotecan)
Maltese: bevacizumab, cisplatin, irinotecan),
English: PVC/PVdC/Aluminium blisters
Maltese: Folji tal-PVC/PVdC/Aluminju 3 snin
English: Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4)
Maltese: Sindrome ta' Stevens-Johnson u Nekrolisi tossika talEpidermide (rari ħafna) (ara sezzjoni 4.4.)
English: There was a small increase in plasma concentrations of capecitabine and one metabolite 5'-deoxy-5-fluorocytidine (5'-DFCR); there was no effect on the 3 major metabolites: 5'-deoxy-5-fluorouridine (5'-DFUR), 5-FU and α-fluoro-β-alanine (FBAL).
Maltese: Kien hemma żjieda żgħira fil-konċentrazzjonijiet fil-plażma ta' capecitabine u metabolit wieħed 5'-deoxy-5-fluorocytidine (5'-DFCR); ma kien hemm l-ebda effett fuq il-3 metaboliti maġġuri: 5'-deoxy-5-fluorouridine (5'-DFUR), 5-FU u α-fluoro-β-alanine (FBAL).
English: • loss of appetite (anorexia)
Maltese: • telf tal-aptit (anoreksja)
English: • Fever: if you have a temperature of 38 °C or greater.
Maltese: - Deni: jekk ikollok temperatura ta' 38 °C jew iżjed.
English: Hepatic failure (rare), Cholestatic hepatitis (rare)
Maltese: Insuffiċjenza tal fwied (rari), Epatite kolestatika (rari)
English: Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Maltese: Mhux applikabbli *Skont il-Kriterji Komuni tat-Tossiċità (verżjoni 1) tal-Grupp ta' Provi Kliniċi tal-Istitut Nazzjonali tal-Kanċer tal-Kanada (NCIC CTG), jew il-Kriterji ta' Terminoloġija Komuni għall-Avvenimenti Avversi (CTCAE) talProgramm ta' Valutazzjoni tat-Terapija tal-Kanċer, Istitut Nazzjonali tal-Kanċer tal-Istati Uniti, verżjoni 4.0.
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6 % (capecitabine + docetaxel) vs. 29.7 % (docetaxel alone); p = 0.0058.
Maltese: Ir-rati oġġettivi tar-respons totali fil-popolazzjoni li ġiet magħżula każwalment (valutazzjoni investigattiva) kienu ta' 41.6 % (capecitabine + docetaxel) vs. 29.7 % (docetaxel waħdu); p = 0.0058.
English: Capecitabine medac is available in blisters (Aluminium-Aluminium or PVC/PVdC-Aluminium).
Maltese: Capecitabine medac jiġi f'folji (Aluminju- Aluminju jew PVC/PVdC-Aluminju).
English: Tablet core: anhydrous lactose, croscarmellose sodium (E468), hypromellose (E464), microcrystalline cellulose (E460), magnesium stearate (E572) - see section 2 “Capecitabine medac contains lactose”.
Maltese: Qalba tal-pillola: anhydrous lactose, croscarmellose sodium (E468), hypromellose (E464), microcrystalline cellulose (E460), magnesium stearate (E572) - ara sezzjoni 2 “Capecitabine medac fih lactose”.
English: Leucovorin 200 mg/m² intravenous 2 hr
Maltese: Leucovorin 200 mg/m² fil-vini 2 hr
English: +Neutropenia, +Leukopenia, +Anaemia, +Neutropenic fever, Thrombocytopenia
Maltese: +Newtropenija, +Lewkopenija, +Anemija, +Deni newtropeniku,
English: In a clinical pharmacokinetic interaction study, after a single 20 mg dose of warfarin, capecitabine treatment increased the AUC of S-warfarin by 57 % with a 91 % increase in INR value.
Maltese: Fi studju kliniku farmakokinetiku dwar l-interazzjonijiet, wara doża waħda ta' 20 mg ta' warfarin, ittrattament b'capecitabine żied l-AUC ta' S-warfarin b'57 % b'żieda ta' 91 % fil-valur tal-INR.
English: The most commonly reported and/or clinically relevant treatment-related ADRs were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), HFS (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with pre-existing compromised renal function, and thrombosis/embolism.
Maltese: L-aktar ADRs relatati mat-trattament irrappurtati b'mod frekwenti u/jew ta' rilevanza klinika kienu disturbi gastrointestinali (speċjalment dijarea, tqalligħ, rimettar, uġigħ addominali, stomatite), HFS (eritrodisasteżija palmari-plantari), għeja, astenja, anoreksja, kardjotossiċità, disfunzjoni renali miżjuda f'dawk b'funzjoni renali kompromessa minn qabel, u trombożi/emboliżmu.
English: Anhydrous lactose Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Hypromellose (E464) Magnesium stearate (E572)
Maltese: Il-qalba tal-pillola Anhydrous lactose Microcrystalline cellulose (E 460) Croscarmellose sodium (E468) Hypromellose (E464) Magnesium stearate (E572)
English: 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).
Maltese: Il-kategoriji li ġejjin huma wżati biex jikklassifikaw l-ADRs skont il-frekwenza: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000).
English: • for the treatment of metastatic colorectal cancer (see section 5.1).
Maltese: • kanċer metastatiku tal-kolorektum (ara sezzjoni 5.1).
English: If you have an unrecognised DPD deficiency and take Capecitabine medac, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects.
Maltese: Jekk għandek defiċjenza ta' DPD mhux magħrufa u tieħu Capecitabine medac, għandek riskju ogħla ta' bidu akut bikri ta' forom qawwija tal-effetti sekondarji elenkati taħt sezzjoni 4 Effetti sekondarji possibbli.
English: Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (p = 0.09), and 18.9 months for XELIRI (p = 0.27).
Maltese: OS medjana kienet ta' 23.1 xhur għal FOLFIRI, 17.6 xhur għal mIFL (p = 0.09), u 18.9 xhur għal XELIRI (p = 0.27).
English: Oxaliplatin 85 mg/m² intravenous 2 hr
Maltese: Oxaliplatin 85 mg/m² fil-vini 2 hr
English: Each pack contains 28, 30, 56, 60, 84, 112, or 120 film-coated tablets.
Maltese: Kull pakkett fih 28, 30, 56, 60, 84, 112, jew 120 pillola miksija b'rita.
English: In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of PFS (hazard ratio 1.01; 97.5 % CI 0.84 - 1.22).
Maltese: F'dan il-paragun ta' sottogrupp ta' trattament, XELOX u bevacizumab kien simili meta mqabbel ma' FOLFOX-4 u bevacizumab f'termini ta' PFS (hazard ratio 1.01; 97.5 % CI 0.84 - 1.22).
English: Lacrimal duct stenosis (rare), Corneal disorders (rare), Keratitis (rare), Punctate keratitis (rare)
Maltese: Disturbi fil-kornea (rari), Keratite (rari), Keratite ttikkjata (rari)
English: However this was associated with an increased incidence of gastrointestinal toxicity and neutropenia during first-line treatment with XELIRI (26 % and 11 % for XELIRI and first line capecitabine respectively).
Maltese: Madankollu dan kien assoċjat ma' inċidenza akbar ta' tossiċità gastrointestinali u newtropenija waqt trattament primarju b'XELIRI (26 % u 11 % għall XELIRI u capecitabine bħala trattament primarju rispettivament).
English: For hand-foot syndrome (HFS) and hyperbilirubinaemia, see section 4.4.
Maltese: Għas-sindromu tal-idejn-saqajn (HFS - hand-foot syndrome) u iperbilirubinimja, ara sezzjoni 4.4.
English: The MTD of capecitabine was 2,000 mg/m² per day when combined with interferon alpha- 2a (3 MIU/m² per day) compared to 3,000 mg/m² per day when capecitabine was used alone.
Maltese: L-MTD ta' capecitabine kienet ta' 2,000 mg/m² kuljum meta meħud flimkien ma' interferon alfa-2a (3 MIU/m² kuljum) imqabbla ma' 3,000 mg/m² kuljum meta capecitabine jintuża waħdu.
English: 150 mg 300 mg 500 mg
Maltese: 150 mg 300 mg 500 mg Doża kull għotja (mg)
English: Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48 % and 14 % for XELIRI and FOLFIRI respectively).
Maltese: Pazjenti ttrattati b'XELIRI kellhom tossiċità gastrointestinali eċċessiva meta mqabbla ma' FOLFIRI (dijarea 48 % u 14 % għal XELIRI u FOLFIRI rispettivament.
English: Capecitabine medac 150 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc
Maltese: Capecitabine medac 150 mg pilloli miksija b'rita Hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E 172), talc
English: • nerve pain
Maltese: • uġigħ fin-nervi
English: In an interaction study with single-dose warfarin administration, there was a significant increase in the mean AUC (+57 %) of S-warfarin.
Maltese: Fi studju dwar l-interazzjoni waqt l-għoti ta' doża waħda ta' warfarin, kien hemm żieda sinifikattiva fil-medja tal-AUC (+57 %) ta' S-warfarin.
English: A significant reduction in the risk of progression was associated with FOLFIRI (HR, 0.76; 95 % CI, 0.62-0.95; P < 0.01), a result partly due to poor tolerance to the XELIRI regimens used.
Maltese: Tnaqqis sinifikanti fir-riskju ta' progressjoni kien assoċjat ma' FOLFIRI (HR, 0.76; CI ta' 95 %, 0.62-0.95; P < 0.01), riżultat parzjalment ikkawżat minn tolleranza baxxa għall-korsijiet ta' XELIRI użati.
English: Capecitabine medac 300 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), talc Capecitabine medac 500 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc
Maltese: Capecitabine medac 300 mg pilloli miksija b'rita Hypromellose (E464), titanium dioxide (E171), talc Capecitabine medac 500 mg pilloli miksija b'rita Hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E 172), talc
English: • medicines used to treat folic acid deficiency
Maltese: • mediċini użati biex jittrattaw defiċjenza ta' folic acid.
English: Capecitabine medac contains sodium
Maltese: Capecitabine medac fih sodium
English: • Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug drug interaction),
Maltese: • Trattament reċenti jew fl-istess waqt bi brivudine (ara sezzjonijiet 4.4 u 4.5 għall-interazzjoni bejn mediċina u oħra),
English: Pharmacotherapeutic group: Pyrimidine analogues, antineoplastic agents, ATC code: L01BC06
Maltese: Analogi tal-pyrimidine, sustanzi antineoplastiċi Kodiċi ATC:
English: Oxaliplatin 130 mg/m² intravenous 2 hr
Maltese: Oxaliplatin 130 mg/m² fil-vini 2 hr
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n = 167) or XELIRI plus bevacizumab (Arm-B, n-166).
Maltese: FOLFIRI flimkien ma' bevacizumab (Grupp-A, n = 167) jew XELIRI flimkien ma' bevacizumab (Grupp-B , n = 166).