FrancophonIA/ELRC3.0 huggingface dataset:
English: After 377 deaths, the overall survival was 18.6 months versus 15.8 months (log rank p=0.0489, HR 0.82) in patients treated with gemcitabine/paclitaxel compared to patients treated with paclitaxel and the overall response rate was 41.4% and 26.2% respectively (p= 0.0002).
Maltese: Wara li mietu 377 pazjent is-sopravivenza totali kienet ta' 18.6 xhur kontra 15.8 xhur (log rank p=0.0489, HR 0.82) f'pazjenti kkurati b'gemcitabine/paclitaxel meta mqabbla ma' pazjenti kkurati b'paclitaxel u r-rata ta' rispons in ġenerali kienet ta' 41.4% u 26.
English: Abnormal urine tests: protein in urine Flu like symptoms including fever Oedema (swelling of ankles, fingers, feet, face)
Maltese: Testijiet ta' l-awrina mhux normali : proteini fl-awrina Sintomi li jixbħu dawk ta' l-influwneza inkluż id-deni Edima (nefħa fl-għekiesi, swaba', saqajn, wiċċ)
English: For the indication in bladder cancer, the MAH provided data from two Phase 2 studies and from a pivotal Phase 3, showing that gemcitabine chemotherapy is active, tolerable, displays manageable toxicity and superiority to MVAC (methotrexate, vinblastine, adriamycin and cisplatin) chemotherapy in the treatment of patients with advanced or metastatic transitional cell carcinoma of the urothelium.
Maltese: Għall-indikazzjoni f'kanċer tal-bużżieqa ta' l-awrina, il-MAH ipprovda dejta minn żewġ studji ta' Fażi 2 u minn wieħed ewlieni ta' Fażi 3, li juri li l-kimoterapija gemcitabine hija attiva, tollerabbli, turi tossiċità u superjorità maniġjevoli għal kimoterapija MVAC (methotrexate, vinblastine, adriamycin u cisplatin) filkura ta' pazjenti b'karċinoma ta' ċellola transizzjonali avvanzata jew metastatika tal-jurotiljum.
English: Radiation toxicity (see section 4.5).
Maltese: Tossiċità mir-radjazzjoni (ara sezzjoni 4.5).
English: Gemzar (gemcitabine) is a pyrimidine antagonist (an antimetabolite) that is metabolised intracellularly to active diphosphate and triphosphate nucleosides which inhibit DNA synthesis.
Maltese: Gemzar (gemcitabine) huwa antagonista ta' pyrimidine (antimetabolit) li huwa metabolizzat ġewwa ċ-ċelloli għal nukleosidi difosfati u trifosfati attivi li jimpedixxu s-sinteżi ta' DNA.
English: Respiratory, thoracic and mediastinal disorders Pulmonary oedema
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Systemic clearance ranged from 29.2 l/hr/m2 to 92.2 /hr/m2 depending on gender and age (inter-individual variability was 52.2%).
Maltese: Eskrezzjoni It-tneħħija sistemika tvarja minn 29.2 l/siegħa/m sa 92.2 siegħa/m skond is-sess u l-età (il-varjabbilità bejn individwu u ieħor kienet ta' 52.2%).
English: Pulmonary effects, sometimes severe (such as pulmonary oedema, interstitial pneumonitis or adult respiratory distress syndrome (ARDS)) have been reported in association with gemcitabine therapy.
Maltese: Ġew irrapportati effetti pulmonarji xi kultant severi (bħal edima pulmonari, pnewmonite interstizjali jew sindromu ta' diffikultà respiratorja ta' l-adulti (ARDS)) b'rabta mat-terapija ta' gemcitabine.
English: The following indications are currently approved for Gemzar and were assessed by the CHMP: 1) Bladder cancer, 2) Advanced Non- small cell lung cancer, 3) Advanced pancreatic cancer, 4) Breast cancer and 5) Ovarian cancer.
Maltese: L-indikazzjonijiet li ġejjin huma fil-preżent approvati għal Gemzar u kienu evalwati mill-CHMP: 1) Kanċer tal-bużżieqa ta' l-awrina, 2) Kanċer ta' ċelloli tal-pulmun mhux żgħir avvanzat, 3) Kanċer pankrejatiku avvanzat, 4) Kanċer tas-sider 5) Kanċer ta' l-ovarju.
English: 6.3 Shelf life
Maltese: Half-life:
English: After reconstitution, the solution contains 38 mg/ml of gemcitabine.
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni fiha 38 mg/ml ta' gemcitabine.
English: • Increased gamma-glutamyl transferase (GGT)
Maltese: • Żieda fil-livell ta' gamma-glutamyl transferase (GGT) Disturbi fil-ġilda u fit-tessut ta' taħt il-ġilda Komuni ħafna
English: Injury, poisoning and procedural complications Radiation recall
Maltese: Feriti, avvelenament u komplikazzjonijiet filproċedura
English: Eli Lilly ČR, s.r.o., Pobřežní 1a, 186 00 Praha 8 Czech Republic
Maltese: Is-Slovakkja Eli Lilly ČR, s.r.o., Pobřežní 1a, 186 00 Praha 8
English: Gemcitabine shows significant cytotoxic effects against a variety of cultured murine and human tumour cells.
Maltese: Gemcitabine juri effetti ċitotossiċi sinifikanti kontra numru varjat ta' ċelluli tumorali kkolturati umani u tal-ġrieden.
English: Each pack of Gemzar contains 1 vial.
Maltese: Kull pakkett ta' Gemzar fih kunjett 1.
English: The most commonly reported adverse drug reactions associated with Gemzar treatment include: nausea with or without vomiting, raised liver transaminases (AST/ALT) and alkaline phosphatase, reported in approximately 60% of patients; proteinuria and haematuria reported in approximately 50% patients; dyspnoea reported in 10-40% of patients (highest incidence in lung cancer patients); allergic skin rashes occur in approximately 25% of patients and are associated with itching in 10% of patients.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina irrapportati b'mod komuni assoċjati mal-kura b'Gemzar jinkludu: tqalligħ bir-rimettar jew mingħajr rimettar, livelli għoljin tat-transaminases t[U1]al-fwied (AST/ALT) u alkaline phosphatase li ġew irrapportati f'madwar 60 % tal-pazjenti; proteina u demm flawrina rrapportati f'madwar 50 % tal-pazjenti; diffikultà biex tieħu n-nifs irrapportata f'10-40 % talpazjenti (l-ogħla inċidenza f'pazjenti b'kanċer tal-pulmun); raxxijiet allerġiċi fuq il-ġilda jseħħu f'madwar 25 % tal-pazjenti u f'10 % tal-pazjenti huma assoċjati ma' ħakk.
English: Cisplatin has been used at doses between 75-100 mg/m2 once every 3 weeks.
Maltese: Cisplatin intuża f'dożi bejn 75-100 mg/m darba kull 3 ġimgħat.
English: • Rhinitis
Maltese: • Rinite
English: Differences in response rate of 47.2% in the GCb arm versus 30.9% in the Cb arm (p=0.0016) and median survival 18 months (GCb) versus 17.3 (Cb) (p=0.73) favoured the GCb arm.
Maltese: fil-fergħa ta' Cb (p=0.0016) u sopravivenza medjana ta' 18-il xahar (GCb) kontra 17.3 (Cb) (p=0.73) iffavorixxew il-fergħa ta' GCb.
English: Important information about some of the ingredients of Gemzar Gemzar contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial and 17.5 mg (< 1 mmol) sodium in each 1000 mg vial.
Maltese: Gemzar fih 3.5 mg (< 1 mmol) ta' sodium f'kull kunjett ta' 200 mg u 17.5 mg (< 1 mmol) ta' sodium f'kull kunjett ta' 1000mg.
English: HOW TO STORE GEMZAR
Maltese: XJENTIFIKA TA' GEMZAR
English: Take special care with Gemzar:
Maltese: X'fih Gemzar:
English: Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium chloride solution for injection, without preservative, or 25 ml sterile sodium chloride solution for injection, without preservative to the 1000 mg vial.
Maltese: Irrikostitwixxi l-kunjetti ta' 200 mg b'5 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni għall-injezzjoni ta' sodium chloride sterili, mingħajr preservanti jew għall-kunjett ta' 1000 mg, 25 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride sterili mingħajr preservanti.
English: • Thrombocytosis
Maltese: • Tromboċitopenja
English: Gemzar was included in the list of products for SPC harmonisation, in accordance with Article 30(2) of Directive 2001/83/EC, as amended because of the divergences existing amongst the nationally authorised SPCs due to the divergent national decisions taken by Member States.
Maltese: Gemzar kien inkluż fil-lista ta' prodotti għall-armonizzazzjoni tal-SPC, b'mod konformi ma' l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendat minħabba d-diverġenzi li jeżistu fost l-SPC awtorizzati fuq livell nazzjonali minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri.
English: In a randomised phase III study of 529 patients with inoperable, locally recurrent or metastatic breast cancer with relapse after adjuvant/neoadjuvant chemotherapy, gemcitabine in combination with paclitaxel showed a statistically significant prolongation of time to documented disease progression from 3.98 to 6.14 months (log-rank p=0.0002) in patients treated with gemcitabine/paclitaxel compared to patients treated with paclitaxel.
Maltese: III, b'529 pazjent b'kanċer tas-sider,lokalment rikorrenti jew metastatiku, inoperabbli u b'rikadenza wara kimoterapija awżiljarja/awżiljarja għall-ewwel darba, gemcitabine flimkien ma' paclitaxel urew żieda statistikament sinifikanti fiż-żmien għal progressjoni ta' mard dokument minn 3.98 sa 6.14 xhur (log-rank p=0.0002) f'pazjenti kkurati b'gemcitabine/paclitaxel meta mqabbla ma' pazjenti kkurati b'paclitaxel.
English: In a randomised phase III study of 522 patients with inoperable, locally advanced or metastatic NSCLC, gemcitabine in combination with cisplatin showed a statistically significant higher response rate than cisplatin alone (31.0% and 12.0%, respectively, p<0.0001).
Maltese: III f'522 pazjent b'NSCLC avvanzat lokalment jew metastatiku u mhux operabbli, gemcitabine flimkien ma' cisplatin urew rata ta' rispons statistikament ogħla b'mod sinifikanti meta mqabbla ma' cisplatin waħdu (31.0% u 12.0%, rispettivament, p<0.0001).
English: • Anaemia
Maltese: • Anemija Komuni
English: • Febrile neutropaenia Very rare
Maltese: • Għaraq Rari
English: The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively.
Maltese: Il-volum totali wara rrikostituzzjoni hu ta' 5.26 ml (kunjett ta' 200 mg) jew ta' 26.3 ml (kunjett ta' 1000 mg) rispettivament.
English: Each vial contains 200 or 1000 mg of gemcitabine.
Maltese: Kull kunjett fih 200 jew 1000 mg ta' gemcitabine.
English: Laboratory Anaemia Thrombocytopaenia Non-laboratory Nausea and vomiting Diarrhoea Infection Stomatitis
Maltese: Laboratorju Anemija Tromboċitopenja Mhux ta' laboratorju Tqalligħ u rimettar Dijarea Infezzjoni Stomatite
English: • Chills
Maltese: • Tqalligħ
English: Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
Maltese: Kimoterapija preċedenti kellha tinkludi anthracycline sakemm mhux klinikament kontraindikat.
English: Eli Lilly ČR, s.r.o, Pobřežní 1A, 186 00 Praha 8 Czech Republic
Maltese: Eli Lilly ČR, s.r.o, Pobřežní 1A, 186 00
English: A statistically significant prolongation of the time to progression, from 4.3 to 6.9 months (p=0.014) was observed in patients treated with gemcitabine/cisplatin compared to patients treated with etoposide/cisplatin.
Maltese: Ġiet osservata żieda fiżżmien għal progressjoni statistikament sinifikanti minn 4.3 sa 6.9 xhur (p=0.014) f'pazjenti kkurati b'gemcitabine/cisplatin meta mqabbla ma' pazjenti kkurati b'etoposide/cisplatin.
English: consecutive weeks with therapeutic thoracic radiation to patients with non-small cell lung cancer, significant toxicity in the form of severe, and potentially life threatening mucositis, especially oesophagitis, and pneumonitis was observed, particularly in patients receiving large volumes of radiotherapy [median treatment volumes 4,795 cm3].
Maltese: Ġiet murija tossiċità sinifikanti fil-forma ta' mukosite severa u potenzjalment fatali speċjalment esofaġite u pnewmonite, l-aktar f'pazjenti li rċevew volumi kbar ta' radjazzjoni [volumi ta' kura medjani 4,795cm
English: Gemzar 1000 mg contains 17.5 mg (< 1 mmol) sodium per vial.
Maltese: Kull kunjett ta' Gemzar 1000 mg fih 17.5 mg (<1 mmol) ta' sodium.
English: Clinical findings consistent with the haemolytic uraemic syndrome (HUS) were rarely reported in patients receiving gemcitabine (see section 4.8).
Maltese: Sejbiet kliniċi li jindikaw is-sidromu uremiku emolitiku (HUS), ġew irrapportati rarament f'pazjenti li qed jirċievu gemcitabine (ara sezzjoni 4.8).
English: Each 200 mg vial contains 3.5 mg (<1 mmol) sodium.
Maltese: Kull kunjett ta' 200 mg fih 3.5 mg (<1 mmol) sodium.
English: Gemzar 200 mg contains:
Maltese: Gemzar 200 mg fih:
English: • Mild proteinuria
Maltese: • Proteinurja ħafifa
English: The CHMP agreed that gemcitabine used as single agent has shown activity against NSCLC but considered that the combination treatment with gemcitabine + cisplatin is the first line of treatment in patients with advanced/metastatic NSCLC and therefore asked the MAH to further justify the indication of Gemzar as combination treatment and as single agent in NSCLC, bearing in mind that single-agent therapy will usually be restricted to patients with a borderline performance status, elderly patients or pretreated patients.
Maltese: Il-CHMP qabel li gemcitabine użat bħala sustanza waħidha wera attività kontra NSCLC iżda ikkunsidra li kura ta' kumbinazzjoni b'gemcitabine + cisplatin hija l-ewwel linja ta' kura f'pazjenti b' NSCLC avvanzata/metstatika u għalhekk talab lill-MAH biex jiġġustifika iktar l-indikazzjoni ta' Gemzar bħala kura ta' kombinazzjoni u bħala mediċina waħidha f'NSCLC, filwaqt li qies li terapija ta' mediċina waħidha ġeneralment tkun ristretta għal pazjenti bi stejtus ta' eżekuzzjoni fil-limitu, pazjenti anzjani jew pazjenti diġà ikkurati.
English: During the week following administration, 92 to 98% of the dose of gemcitabine administered is recovered, 99% in the urine, mainly in the form of dFdU and 1% of the dose is excreted in faeces.
Maltese: Matul il-ġimgħa wara li jingħata, 92 sa 98% tad-doża ta' gemcitabine li tkun ingħatat tiġi rkuprata.
English: Mean steady state volume of distribution (Vss): 150 l/m2 (range 96-228 l/m2).
Maltese: Medja tal-volum tad-distribuzzjoni fiss (Vss): 150 l/m
English: When gemcitabine is administered daily, high mortality among the animals but minimal antitumoural activity is observed.
Maltese: Meta gemcitabine jingħata kuljum, kien hemm mortalità kbira fost il-bhejjem u attività antitumorali minima.
English: Eli Lilly ČR, s.r.o, Pobřežní 1A, , 186 00 Praha 8 Czech Republic
Maltese: Eli Lilly ČR, s.r.o, Pobřežní 1A, , 186 00
English: Radiotherapy
Maltese: Radjoterapija
English: Eli Lilly Holdings Linited, Kingsclere Road, Basingstoke,
Maltese: L-Estonja Eli Lilly Holdings Limited Kingsclere Road,
English: Cytotoxic activity in cell cultures
Maltese: Attività ċitotossika f'kolturi ta' celluli
English: Finally, a number of additional minor comments, including comments to remaining sections of the SPC, were made by the CHMP and implemented directly in the SPC text.
Maltese: Finalment, saru numru ta' kummenti minuri addizjonali mill-CHMP, inklużi kummenti għas-sezzjonijiet tal-SPC li baqgħu u ġew implimentati direttament fit-test tal-SPC.
English: Grade 3 and 4 Adverse Events Paclitaxel versus gemcitabine plus paclitaxel Number (%) of Patients Paclitaxel arm (N=259)
Maltese: Numru (%) ta' Pazjenti Fergħa ta' paclitaxel (N=259)
English: • Haematuria
Maltese: • Ematurja
English: Each 1000 mg vial contains 17.5 mg (<1 mmol) sodium.
Maltese: Kull kunjett ta' 1000 mg fih 17.5 mg (<1 mmol) sodium.
English: Low haemoglobin level (anaemia) Low white blood cells
Maltese: Livell baxx ta' emoglobina (anemija)
English: • Platelets < 25,000 x 106/l
Maltese: • Newtropenija febrili • Plejtlits < 25,000 x 10
English: • rare: affects 1 to 10 users in 10,000
Maltese: • rari: jaffettwa minn 1 sa 10 pazjenti minn kull 10,000
English: First, dFdCDP inhibits ribonucleotide reductase, which is uniquely responsible for catalysing the reactions that produce deoxynucleoside triphosphates (dCTP) for DNA synthesis.
Maltese: L-ewwel, dFdCDP, jinibixxi ribonucleotide reductase, li huwa l-uniku risponsabbli biex jikkatalizza r-reazzjonijiet li jipproduċu deoxynucleoside triphosphate (dCTP) għas-sintesi tad-DNA.
English: “Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas”.
Maltese: “Gemcitabine hija indikata għall-kura ta' pazjenti b'adenokarċinoma tal-frixa lokalment avvanzata jew metastatika”.
English: Fluid in the lungs
Maltese: Fluwidi fil-pulmun
English: After incorporation into DNA, gemcitabine appears to induce the programmed cell death process known as apoptosis.
Maltese: Wara l-inkorporazzjoni fid-DNA, gemcitabine jidher li jistimula lproċess ipprogrammat tal-mewt taċ-ċellula magħruf bħala apoptożi.
English: Trough concentration following once weekly dosing: 0.07-1.12 µg/ml, with no apparent accumulation.
Maltese: L-inqas konċentrazzjoni wara dożaġġ ta' darba fil-ġimgħa: 0.07-1.12 µg/ml, bla ma deher li kien hemm xi akkumulazzjoni.
English: “Gemcitabine is indicated in locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence free interval of at least 6 months after-platinum based, first-line therapy”
Maltese: “Gemcitabine hija indikata f'karċinoma epiteljali ta' l-ovarji lokalment avvanzata jew metastatika , f'kombinazzjoni ma' carboplatin, f'pazjenti b'rikaduta tal-marda wara intervall ħieles minn rikaduta ta' mill-inqas 6 xhur wara terapija ta' l-ewwel linja bbażata fuq il-platinju”
English: dFdU kinetics
Maltese: Il-kinetika ta' dFdU
English: For Section 4.4, the MAH addressed impaired renal and hepatic function, paediatric recommendations and concomitant administration of gemcitabine and radiotherapy.
Maltese: Għal Sezzjoni 4.4, il-MAH indirizza funzjoni renali u epatika indebolita, rakkomandazzjonijiet pedjatriċi u għoti konkomittanti ta' gemcitabine u radjuterapija.
English: Uncommon • Interstitial pneumonitis (see section
Maltese: • Pnewmonite interstitzjali (ara sezzjoni 4.4)
English: • Influenza-like symptoms - the most common symptoms are fever, headache, chills, myalgia, asthenia and anorexia.
Maltese: • Sintomi bħal dawk ta' l-influwenzal-aktar sintomi komuni huma deni, uġugħ ta' ras, tregħid, mijalġja, astenja u anoressija.
English: After gemcitabine, carboplatin will be given on Day 1 consistent with a target Area under curve (AUC) of 4.0 mg/ml·min.
Maltese: Wara gemcitabine, jingħata carboplatin fl-ewwel jum konsistenti ma' mira ta' l-Erja taħt il-kurva (AUC) ta' 4.0 mg/ml·min.
English: The MAH focused the discussion on the pivotal randomized Phase 3 Study JHQJ, and the main supportive single-arm Phase 2 Study JHRW.
Maltese: Il-MAH iffoka d-diskussjoni fuq Studju ewlieni randomizzat ta' Fażi 3 JHQJ, u l-fergħa waħda ta' appoġġ ewlenija ta' Fażi 2 ta' Studju JHRW.
English: Gemzar 200 mg contains 3.5 mg (<1 mmol) sodium per vial.
Maltese: Kull kunjett ta' Gemzar 200 mg fih 3.5 mg (<1 mmol) ta' sodium.
English: Dose-limiting adverse reactions are reductions in thrombocyte, leucocyte and granulocyte counts (see section 4.2).
Maltese: Reazzjonijiet avversi li jillimitaw id-doża huma tnaqqis fl-għadd ta' tromboċiti, lewkoċiti u granuloċiti (ara sezzjoni 4.2).
English: A statistically significant prolongation of the time to progression, from 3.7 to 5.6 months (log-rank p<0.0012) and a statistically significant prolongation of median survival from 7.6 months to 9.1 months (log-rank p<0.004) was observed in patients treated with gemcitabine/cisplatin compared to patients treated with cisplatin.
Maltese: 0012) u żieda statistikament sinifikanti fis-sopravivenza medjana minn 7.6 xhur għal 9.1 xhur (log-rank p<0.004) f'pazjenti kkurati b'gemcitabine/cisplatin meta mqabbla ma' pazjenti kkurati b'cisplatin.
English: The CHMP assessed the SPC wording proposed by the MAH and the submitted rationales for the proposal.
Maltese: Il-CHMP ivvaluta l-kitba tal-SPC proposta mill-MAH u r-raġunijiet fundamentali sottomessi għall-proposta.
English: Sleepiness
Maltese: Dijarea
English: Urinary excretion: All.
Maltese: Eskrezzjoni awrinarja:
English: Each vial contains 200 or 1000 mg of gemcitabine (as gemcitabine hydrochloride).
Maltese: Kull kunjett fih 200 jew 1000 mg ta' gemcitabine (bħala gemcitabine hydrochloride).
English: Clinical trial data
Maltese: Tagħrif kliniku
English: Further dilution with sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative can be done.
Maltese: Tista' ssir iżjed dilwizzjoni permezz ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride sterili mingħajr preservanti.
English: Gemcitabine is rapidly metabolised by cytidine deaminase in the liver, kidney, blood and other tissues.
Maltese: Gemcitabine malajr jiġi metabolizzat permezz ta' cytidine deaminase fil-fwied, kliewi, demm u tessuti oħra.
English: For Section 4.8, the CHMP requested the clarification of the presentation of the post-marketing spontaneous report and also proposed a list of revised terms to be used in all the tables of adverse event in combination use in this section.
Maltese: Għal Sezzjoni 4.8, il-CHMP talab ilkjarifikazzjoni tal-preżentazzjoni tar-rapport spontanju ta' wara t-tqegħid fis-suq u ppropona wkoll lista ta' termini rreveduti li jintużaw fit-tabelli kollha ta' episodji avversi wżati f'din is-sezzjoni.
English: Dose modifications due to haematological toxicity in subsequent cycles, for all indications The gemcitabine dose should be reduced to 75% of the original cycle initiation dose, in the case of the following haematological toxicities:
Maltese: Fil-każijiet ta' dawn it-tossiċitajiet ematoloġiċi li ġejjin, id-doża ta' gemcitabine għandha titnaqqas sa 75% tad-doża inizjali taċ-ċiklu oriġinali:
English: Dose modification of gemcitabine within a cycle for ovarian cancer, given in combination with carboplatin Absolute granulocyte count (x 106/l)
Maltese: Aġġustament fid-doża ta' gemcitabine waqt ċiklu għal kanċer fl-ovarji, mogħti flimkien ma' carboplatin Għadd assolut ta' granuloċiti (x 106/l)
English: The usual dose of Gemzar is 1000-1250 mg for every square metre of your body's surface area.
Maltese: Normalment id-doża ta' Gemzar hija ta' 1000-1250 mg għal kull metru kwadru ta' l-erja tal-wiċċ talġisem tiegħek.
English: For Section 4.3, the MAH proposal retained only two of the existing 8 contraindications (relating to hypersensitivity and breast feeding) and removed 6 (hepatic or renal impairment, cisplatin for patients with severe renal failure, pregnancy and lactation, combination with yellow fever, usage in children and concomitant administration of gemcitabine and radiotherapy).
Maltese: Għal Sezzjoni 4.3, il-proposta tal-MAH żammet biss tnejn mit-8 kontraindikazzjonijiet eżistenti (li għandhom x'jaqsmu mas-sensittività eċċessiva u t-treddigħ) u neħħiet 6 (indeboliment epatiku jew renali, cisplatin għal pazjenti b'falliment renali sever, tqala u treddigħ, kumbinazzjoni mad-deni isfar, użu fit-tfal u għoti konkomitanti ta' gemcitabine u radjuterapija).
English: Mean volume of distribution of central compartment: 18 l/m2 (range 11-22 l/m2).
Maltese: (marġni 11-22 l/m
English: • Absolute granulocyte count < 500 x 106/l for more than 5 days
Maltese: • Għadd assolut tal-granuloċiti < 500 x10
English: Intravenous gemcitabine has become widely accepted as the standard of chemotherapy care for advanced pancreatic cancer but has yielded disappointing results as combination treatment in patients with locally advanced (nonresectable) or metastatic pancreatic cancer and the MAH considered that gemcitabine monotherapy remains the standard of chemotherapy care for advanced/metastatic, nonresectable pancreatic adenocarcinoma.
Maltese: Gemcitabine intravenuża ġiet aċċettata b'mod komuni bħala l-istandard ta' kura b'kimoterapija għall-kanċer tal-frixa avvanzat iżda ta riżultati diżappuntanti bħala kura ta' kombinazzjoni f'pazjenti b'kanċer tal-frixa lokalment avvanzat (li ma jistax jitneħħa bil-kirurġija) jew metastatiku u lMAH ikkunsidra li monoterapija b'gemcitabine tibqa' l-istandard ta' kura ta' kimoterapija għalladenokarċinoma pankreatika avvanzata/metastatika, li ma tistax titneħħa bil-kirurġija.
English: Plasma concentrations of the parent compound following a dose of 1,000 mg/m2/30-minutes are greater than 5 µg/ml for approximately 30-minutes after the end of the infusion, and greater than 0.4 µg/ml for an additional hour.
Maltese: Wara doża ta' 1,000 mg/m huma iżjed minn 5 µg/ml għal madwar 30 minuta mit-tmiem ta' l-infużjoni, u għal siegħa oħra huma iżjed minn 0.4 µg/ml .
English: This improvement in PFS and response rate is only associated with some additional, readily manageable toxicity, resulting in a favourable risk benefit profile.
Maltese: Dan it-titjib f'PFS u r-rata ta' reazzjoni huma assoċjati biss b'xi tossiċità faċilment maniġevoli, addizjonali, li tirriżulta fi profil ta' riskju benefiċċju favorevoli.