FrancophonIA/ELRC3.0 huggingface dataset:
English: Yellow fever vaccine and other live attenuated vaccines are not recommended in patients treated with gemcitabine (see section 4.5).
Maltese: Il-vaċċin tal-yellow fever u vaċċini oħra b'viruses ħajjin iżda attenwati, m'humiex rakkomandati f'pazjenti kkurati b'gemcitabine (ara sezzjoni 4.5).
English: • common: affects 1 to 10 users in 100
Maltese: • komuni: jaffettwa minn 1 sa 10 pazjenti minn kull 100
English: For Section 4.2, the MAH proposed a harmonised wording, addressing in particular the sections about dosage adjustment, about impaired renal function and on precautions in administration.
Maltese: Għal Sezzjoni 4.2, il-MAH ippropona kitba armonizzata, li tindirizza b'mod partikolari s-sezzjonijiet dwar aġġustament fid-dożaġġ, dwar indeboliment tal-funzjoni renali u dwar prekawzjonijiet fl-għoti.
English: The recommended dose for gemcitabine is 1000 mg/m2, given by 30-minute infusion.
Maltese: Id-doża rrakkomandat ta' gemcitabine hija ta' 1000 mg/m2, li tingħata b'infużjoni ta' 30 minuta.
English: Combination use
Maltese: Użu kkombinat
English: PACKAGE LEAFLET
Maltese: Pożoloġija rrakkomandata
English: • Constipation
Maltese: • Astenja
English: Gemcitabine and paclitaxel combination therapy Combination therapy did not alter the pharmacokinetics of either gemcitabine or paclitaxel.
Maltese: Terapija kkombinata ta' gemcitabine u paclitaxel Il-farmakokinetika kemm ta' gemcitabine u kemm ta' paclitaxel ma tbidlitx minħabba t-terapija kkombinata.
English: The CHMP reviewed the information regarding the use of Gemcitabine in ovarian cancer and was of the opinion that the combination gemcitabine/carboplatin is an option in second line therapy in patients with sensitive platinum disease and an alternative in patients with previous paclitaxel/carboplatin toxicity (Therefore the CHMP retained the indication in ovarian cancer in the harmonised SPC, with the wording:
Maltese: Il-CHMP irreveda t-tagħrif rigward l-użu ta' Gemcitabine f'kanċer ta' l-ovarji u kien ta' l-opinjoni li l-kombinazzjoni gemcitabine/carboplatin hija għażla fit-terapija tat-tieni linja f'pazjenti b'mard sensittiv għal platinju u alternattiva f'pazjenti b'tossiċità ta' qabel b'paclitaxel/carboplatin (Għaldaqstant il-CHMP żamm l-indikazzjoni f'kanċer ta' l-ovarju fl-SPC armonizzat, bil-kitba:
English: This yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder.
Maltese: Dan jagħti konċentrazzjoni ta' gemcitabine ta' 38 mg/ml, li jinkludi fih il-volum ta' spustament tat-trab lijofilizzat.
English: Gemcitabine in combination with carboplatin is recommended using gemcitabine 1000 mg/m2 administered on Days 1 and 8 of each 21-day cycle as a 30-minute intravenous infusion.
Maltese: Gemcitabine flimkien ma' carboplatin huwa rrakkomandat b'gemcitabine 1000 mg/m jingħata fl-ewwel u t-tmien jum ta' kull ċiklu ta' 21 jum bħala infużjoni fil-vini ta' 30 minuta.
English: The CHMP retained the conservative age of 18 and also noted that information regarding hepatic impairment was included and therefore requested the MAH to further discuss patients with renal or hepatic impairment and whether severe impairment had significant effect on gemcitabine pharmacokinetics.
Maltese: Il-CHMP żamm l-età konservattiva ta' 18 u innota wkoll li tagħrif rigward indeboliment epatiku kien inkluż u għaldaqstant talab lill-MAH biex jiddiskuti iktar il-pazjenti b'indeboliment renali jew epatiku u jekk indeboliment sever kellux effett sinjifikanti fuq il-farmakokinetiċi ta' gemcitabine.
English: • bladder cancer, together with cisplatin.
Maltese: • kanċer fil-bużżieqa ta' l-awrina, flimkien ma' cisplatin.
English: The following information is intended for medical or healthcare professionals only:
Maltese: Meta tieħu mediċini oħra:
English: The volume of distribution of the peripheral compartment was 47.4 l/m2.
Maltese: Il-volum ta' distribuzzjoni fil-kompartiment periferali kien ta' 47.
English: Of these patients, approximately 45% had non-small cell lung cancer and 35% were diagnosed with pancreatic cancer.
Maltese: Minn dawn il-pazjenti, madwar 45 % kellhom kanċer tal-pulmun mhux b'ċelluli żgħar u 35% kellhom kanċer tal-frixa.
English: Each pack contains 1 vial
Maltese: Kull pakkett fih kunjett 1
English: Reconstitution at concentrations greater than 40 mg/ml may result in incomplete dissolution and should be avoided.
Maltese: Jekk irrikostituzzjoni issir f'konċentrazzjonijiet ogħla minn 40 mg/ml, jista' jkun li t-trab ma jkunx inħall sew u dan għandu jiġi evitat.
English: Instructions for reconstitution (and further dilution, if performed) The only approved diluent for reconstitution of gemcitabine sterile powder is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative).
Maltese: L-uniku dilwent approvat għar-rikostituzzjoni tat-trab sterili ta' gemcitabine huwa sodium chloride 9 mg/ml (0.9%), soluzzjoni għall-injezzjoni (mingħajr preservant).
English: For cisplatin, carboplatin, and paclitaxel dosage adjustment in combination therapy, please refer to the corresponding Summary of Product Characteristics.
Maltese: Għall-aġġustamenti fid-dożi ta' cisplatin, carboplatin u paclitaxel f'terapija kkombinata, jekk jogħġbok irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott korrispondenti.
English: Czech Republic
Maltese: Ngħas
English: RG21 6XA
Maltese: Hampshire RG21 6AX
English: Gastrointestinal disorders Ischaemic colitis
Maltese: Disturbi repiratorji,toraċiċi u medjastinali Edima pulmonarja
English: Stroke
Maltese: TIKKETTA
English: Common • Increased bilirubin
Maltese: Disturbi fil-qalb
English: There is no known antidote for overdose of gemcitabine.
Maltese: M'hemmx antidotu għal doża eċċessiva ta' gemcitabine.
English: “Gemcitabine is indicated in the treatment of locally advance or metastatic bladder cancer in combination with cisplatin.”.
Maltese: “Gemcitabine hija indikata fil-kura ta' kanċer tal-bużżieqa ta' l-awrina lokalment avvanzat jew metastatiku f'kombinazzjoni ma' cisplatin”.
English: Gemcitabine is mutagenic in an in vitro mutation test and an in vivo bone marrow micronucleus test. Long term animal studies evaluating the carcinogenic potential have not been performed.
Maltese: Gemcatibine huwa mutaġeniku f'test ta' mutazzjoni magħmul in vitro u f'test ta' mikronukleus filmudullun magħmul in vivo.
English: Intracellular concentrations increase in proportion to gemcitabine doses of 35-350 mg/ m2/30-minutes, which give steady state concentrations of 0.4-5 µg/ml.
Maltese: 2/30-minuta l-konċentrazzjonijiet fil-plażma tas-sustanza oriġinali 45.5 µg/ml.
English: Gemcitabine (difluorodeoxy-cytidine (dFdC)) is a cytotoxic anti-cancer agent, which exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and under certain conditions blocking the progression of cells through the G1/S phase boundary.
Maltese: Gemcitabine (difluoro-deoxy-cytidine (dFdC)) hija mediċina ċitotossika kontra l-kanċer, li tesibixxi speċifiċità tal-fażi ta' ċellola, billi primarjament toqtol ċelloli li qegħdin iġarrbu sinteżi tad-DNA (fażi-S) u taħt ċerti kundizzjonijiet jimblokka lprogressjoni ta' ċelloli minn ġewwa l-konfini tal-fażi G1/S.
English: Gemcitabine in combination with paclitaxel is recommended using paclitaxel (175 mg/m2) administered on Day 1 over approximately 3-hours as an intravenous infusion, followed by gemcitabine (1250 mg/m2) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle.
Maltese: Kanċer tas-sider Użu kkombinat Gemcitabine flimkien ma' paclitaxel huwa rrakkomandat b'paclitaxel (175 mg/m 2) jingħata fl-ewwel jum 2) bħala infużjoni filbħala infużjoni fil-vini ta' madwar 3 sigħat, u wara jingħata gemcitabine (1250 mg/m vini ta' 30 minuta fl-ewwel u t-tmien jum ta' kull ċiklu ta' 21 jum.
English: Ovarian carcinoma
Maltese: Karċinoma ta' l-ovarji
English: Doses as high as 5700 mg/m2 have been administered by intravenous infusion over 30-minutes every 2 weeks with clinically acceptable toxicity.
Maltese: Dożi li laħqu sa 5700 mg/m2 ġew mogħtija permezz ta' infużjoni minn ġol-vini għal 30 minuta kull ġimgħatejn b'tossiċitajiet li kienu klinikament aċċettabbli.
English: Vomiting
Maltese: Gemcitabine
English: • uncommon: affects 1 to 10 users in 1,000
Maltese: • mhux komuni: jaffettwa minn 1 sa 10 pazjenti minn kull 1,000
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih gemcitabine hydrochloride ekwivalenti għal 200 mg gemcitabine Kull kunjett fih gemcitabine hydrochloride ekwivalenti għal 1000 mg gemcitabine
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Maltese: L-istabbilità waqt l-użu kemm kimika u kemm fiżika ġiet ippruvata għal 24 siegħa f'temperatura ta' 30°C.
English: Mean apparent clearance: 2.5 l/hr/m2 (range 1-4 l/hr/m2).
Maltese: (marġni 1-4 l/siegħa/m
English: Combination use The recommended dose for gemcitabine is 1250 mg/m2 body surface area given as a 30-minute intravenous infusion on Day 1 and 8 of the treatment cycle (21 days).
Maltese: Użu kkombinat Id-doża rrakkomandat ta' gemcitabine hija ta' 1250 mg/m ta' l-erja tas-superfiċje tal-ġisem li tingħata b'infużjoni fil-vini ta' 30 minuta fl-ewwel u fit-tmien jum taċ-ċiklu tal-kura (21 jum).
English: Arrythmias, predominantly supraventricular in nature Heart failure
Maltese: Arritmjas, l-iżjed tat-tip supraventrikulari Insuffiċjenza tal-qalb
English: The CHMP noted the pivotal study JHQJ was powered to detect differences in TtDP in overall survival and that the pivotal study for the ovarian cancer had a specific population consisting of platinum sensitive patients with a very poor prognosis and the CHMP was of the opinion that the proposed wording was in accordance with the submitted study for the marketing authorisation in this indication.
Maltese: Għaldaqstant il-CHMP ikkunsidra li l-indikazzjoni wiesa' proposta “kanċer tal-bużżieqa ta' l-awrina” mhijiex iġġustifikata, peress li d-dejta pprovduta ma kinitx biżżejjed biex tappoġġja l-indikazzjoni f'kanċer tal-bużżieqa ta' lawrina superfiċjali.
English: Concurrent (given together or ≤ 7 days apart) - Toxicity associated with this multimodality therapy is dependent on many different factors, including dose of gemcitabine, frequency of gemcitabine administration, dose of radiation, radiotherapy planning technique, the target tissue, and target volume.
Maltese: Fl-istess ħin (mogħtija flimkien jew ≤ 7 tijiem minn xulxin) - It-tossiċità assoċjata ma' din it-terapija b'modalitajiet differenti tiddependi minn ħafna fatturi differenti li jinkludu d-doża ta' gemcitabine, kemmil darba jingħata, id-doża ta' radjazzjoni, it-teknika ta' ippjanar tar-radjoterapija, it-tessut li se jiġi milqut u l-volum ta' dan it-tessut.
English: Laboratory evaluation of renal and hepatic function (including virological tests) should be performed periodically.
Maltese: Kull tant żmien għandu jsir evalwazzjoni fil-laboratorju tal-funzjoni renali u epatiku (inklużi t-testijiet viroloġiċi).
English: Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure) Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.
Maltese: Effetti ta' radjazzjoni li tkun ngħatat qabel- (raxx fil-ġilda simili għal dik ta' ħarqa severa mix-xemx) li tista' sseħ fuq ġilda li xi darba tkun ġiet esposta għar-radjoterapija.
English: Gemzar belongs to a group of medicines called “cytotoxics”.
Maltese: Gemzar jagħmel parti minn grupp ta' mediċini li jissejħu “ċitotossiċi”.
English: In a randomised phase III study of 126 patients with advanced or metastatic pancreatic cancer, gemcitabine showed a statistically significant higher clinical benefit response rate than 5-fluorouracil (23.8% and 4.8% respectively, p=0.0022).
Maltese: Fi studju randomised ta' fażi IIII b'126 pazjenti b'kanċer tal-frixa avvanzat jew metastatiku, gemcitabine wera rata ta' rispons ta' benefiċju kliniku statistikament ogħla b'mod sinifikanti meta mqabbel ma' 5-fluorouracil (23.8% u 4.8% rispettivament, p=0.0022). Ġiet osservata wkoll żieda statistikament sinifikanti fil-ħin għallprogressjoni minn 0.9 sa 2.3 xhur (log-rank p<0.0002) u żieda statistikament sinifikanti fis-sopravivenza medjana minn 4.4 sa 5.7 xhur (log-rank p<0.0024) f'pazjenti kkurati b'gemcitabine meta mqabbla ma' 5fluorouracil.
English: The MAH concluded that the studies demonstrated that gemcitabine plus carboplatin is superior to carboplatin in terms of time to disease progression (TtDP) and response rate in patients with platinumsensitive recurrent ovarian cancer.
Maltese: IlMAH ikkonkluda li l-istudji wrew li gemcitabine flimkien ma' carboplatin huwa superjuri għal carboplatin f'termini ta' żmien għall-progressjoni tal-marda (TtDP) u rata ta' reazzjoni f'pazjenti b'kanċer ta' l-ovarju rikorrenti sensittivi għal platinju.
English: In fertility studies gemcitabine caused hypospermatogenesis in male mice (see section 5.3).
Maltese: Ma sarux studji dwar l-effett ta' mediċini jew ta' affarijiet oħra fuq l-effett farmaċewtiku tal-prodott (ara sezzjoni 5.2).
English: This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder.
Maltese: Din id-dilwizzjoni tagħti konċentrazzjoni ta' gemcitabine ta' 38 mg/ml, li jinkludi fih il-volum ta' spustament tat-trab lijofilizzat.
English: Gemcitabine and carboplatin combination therapy When given in combination with carboplatin the pharmacokinetics of gemcitabine were not altered
Maltese: Terapija kkombinata ta' gemcitabine u carboplatin Il-farmakokinetika ta' gemcitabine ma inbidlitx meta ingħata flimkien ma' carboplatin.
English: The frequency of grade 3 and 4 haematological toxicities, particularly neutropaenia, increases when gemcitabine is used in combination with paclitaxel.
Maltese: Il-frekwenza tat-tossiċitajiet ematoloġiċi ta' grad 3 u 4, speċjalment in-newtropenja, jiżdiedu meta gemcitabine jintuża flimkien ma' paclitaxel.
English: The plasma protein binding was considered to be negligible.
Maltese: L-ammont ta' rbit mal-proteini fil-plażma kien ikkunsidrat negliġibbli.
English: Regarding breast cancer, the MAH only proposed combination use for inclusion in the harmonised SPC, although a Phase 3 study showed the activity of single-agent gemcitabine for the treatment of metastatic breast cancer (MBC).The indication was supported by a clinical expert report and efficacy data from Phase 2 and 3 single-agent studies of Gemzar in the treatment of breast cancer, including studies conducted by the MAH and results from the published literature.
Maltese: L-indikazzjoni kienet appoġġjata permezz ta' rapport kliniku ta' espert u dejta ta' effikaċja minn studji ta' Fażi 2 u 3 ta' Gemzar b'sustanza waħidha fil-kura ta' kanċer tassider, inklużi studji magħmulin mill-MAH u riżultati mill-letteratura ppubblikata.
English: Yellow fever and other live attenuated vaccines are not recommended due to the risk of systemic, possibly fatal, disease, particularly in immunosuppressed patients.
Maltese: Il-vaċċin tal-yellow fever u vaċċini oħrajn b'viruses ħajjin iżda attenwati m'humiex rakkomandati, speċjalment f'pazjenti immunosoppressi, minħabba r-riskju ta' mard sistemiku li jista' jkun fatali.
English: Side effects with Gemzar may include:
Maltese: Effetti sekondarji b'Gemzar jistgħu jinkludu:
English: Gemcitabine is indicated for the treatment of patients with 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 huwa indikat għall-kura ta' pazjenti b'karċinoma ta' l-epitelju ta' l-ovarji lokalment avvanzat jew metastatiku, flimkien ma' carboplatin, f'pazjenti li reġgħu rkadew wara intervall ta' mill-inqas 6 xhur mingħajr rikorrenza wara terapija ta' l-ewwel għażla bbażata fuq platinum.
English: The recommended dose of gemcitabine is 1000 mg/m2, given by 30-minute intravenous infusion.
Maltese: Id-doża rrakkomandat ta' gemcitabine hija ta' 1000 mg/m2, li tingħata b'infużjoni fil-vini ta' 30 minuta.
English: Cough, rhinitis, malaise, perspiration and sleeping difficulties have also been reported.
Maltese: Ġew irrapportati wkoll sogħla, rinite, telqa ġenerali, għaraq eċċessiv u diffikultà biex torqod.
English: Laboratory Anaemia Neutropaenia Thrombocytopaenia Leucopaenia Non-laboratory Haemorrhage Febrile neutropaenia Infection without neutropaenia Sensory neuropathy was also more frequent in the combination arm than with single agent carboplatin
Maltese: Rigward il-kanċer ta' l-ovarji, il-MAH ippropona kitba għall-użu ta' kombinazzjoni f'din l-indikazzjoni, għalkemm attività tidher permezz ta' gemcitabine bħala sustanza waħidha, u pprovda rapport kliniku ta' espert u tagħrif supplimentari biex jappoġġja l-indikazzjoni.
English: To be taken into consideration by patients on a controlled sodium diet.
Maltese: Trid iżżomm dan f'moħħok f'pazjenti li qegħdin fuq dieta kontrollata ta' sodium.
English: • Allergic skin rash frequently associated with pruritus
Maltese: • Raxx allerġika tal-ġilda ħafna drabi assoċjata ma' prurite
English: Patients with renal or hepatic impairment
Maltese: Pazjenti b'indeboliment renali jew epatiku
English: The MAH therefore considered the positive benefit-risk ratio to be established for the use of gemcitabine/cisplatin in the treatment of NSCLC.
Maltese: Għaldaqstant, il-MAH ikkunsidra l-proporzjon benefiċċju-riskju bħala wieħed pożittiv biex ikun stabbilit għall-użu ta' gemcitabine/cisplatin fil-kura ta' NSCLC.
English: In general, for severe (Grade 3 or 4) nonhaematological toxicity, except nausea/vomiting, therapy with gemcitabine should be withheld or decreased depending on the judgement of the treating physician.
Maltese: Ġeneralment, għal tossiċità severa (Grad 3 jew 4) li m'hijiex ematoloġika, ħlief għat-tqalligħ/rimettar, it-terapija b'gemcitabine għandha tinżamm jew titnaqqas skond kif jaħseb ittabib li jkun qed jieħu ħsieb il-kura.
English: Cisplatin is given at a recommended dose of 70 mg/m2 on Day 1 following gemcitabine or day 2 of each 28-day cycle.
Maltese: , erba' darbiet) u cisplatin ( 80 mg/m darbtejn) għal 6 ġimgħat.
English: Pregnancy and breast-feeding
Maltese: Radjoterapija fl-istess żmien
English: EXP
Maltese: Ċipru
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2013
English: * Related to volume depletion; see section 4.4.
Maltese: * Marbuta ma' tnaqqis fil-volum; ara sezzjoni 4.4.
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (AUC)
Maltese: Wara għoti ta' canagliflozin ma' rifampicin (induttur ta' diversi trasportaturi attivi u enzimi li jimmetabolizzaw il-mediċini), kien osservat tnaqqis ta' 51% u 28% fl-esponiment sistemiku (AUC)
English: g
Maltese: c
English: Excipient(s) with known effect Each tablet contains 39.2 mg lactose.
Maltese: Kull pillola fiha 39.2 mg lactose.
English: This effect at the 300 mg dose of canagliflozin may, in part, be due to local inhibition of intestinal SGLT1 (an important intestinal glucose transporter) related to transient high concentrations of canagliflozin in the intestinal lumen prior to medicinal product absorption (canagliflozin is a low potency inhibitor of the SGLT1 transporter).
Maltese: 300 mg ta' canagliflozin jista' jkun minħabba inibizzjoni lokali ta' SGLT1 tal-intestini (trasportatur importanti tal-glukows fl-intestini) marbuta ma' konċentrazzjonijiet temporanji għoljin ta' canagliflozin fil-kavità tal-intestini qabel l-assorbiment tal-prodott mediċinali (canagliflozin huwa inibitur b'qawwa baxxa tat-trasportatur ta' SGLT1).
English: Excipient(s) with known effect Each tablet contains 117.78 mg lactose.
Maltese: Kull pillola fiha 117.78 mg lactose.
English: Simvastatin: The combination of canagliflozin 300 mg once daily for 6 days with a single dose of simvastatin (CYP3A4 substrate) 40 mg resulted in a 12% increase in AUC and a 9% increase in Cmax of simvastatin and an 18% increase in AUC and a 26% increase in Cmax of simvastatin acid.
Maltese: Il-kombinazzjoni ta' canagliflozin 300 mg darba kuljum għal 6 ijiem ma' doża waħda ta' simvastatin (sottostrat ta' CYP3A4) 40 mg wasslet għal żieda ta' 12% fl-AUC u żieda ta' 9% fis-Cmax ta' simvastatin u żieda ta' 18% fl-AUC u żieda ta' 26% fis-Cmax tal-aċidu ta' simvastatin.
English: Consistent with the mechanism of sodium glucose co-transporter 2 (SGLT2) inhibition with increased UGE, vulvovaginal candidiasis in females and balanitis or balanoposthitis in males were reported in clinical trials (see section 4.8).
Maltese: F'konsistenza mal-mekkaniżmu ta' inibizzjoni tal-kotrasportatur 2 ta' sodium u glukows (SGLT2sodium glukows co-transporter 2) b'żieda fil-UGE, kienet irrappurtata kandidjasi vulvovaġinali finnisa u balanite jew balanopostite fl-irġiel fi provi kliniċi (ara sezzjoni 4.8).
English: Renal impairment (eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min) Patients with a baseline eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min had a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) with incidences of 4.7%, 8.1%, and 1.5% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.4).
Maltese: Indeboliment tal-kliewi (eGFR < 60 mL/min/1.73 m2 jew CrCl < 60 mL/min) Pazjenti b'eGFR < 60 mL/min/1.73 m2 jew CrCl < 60 mL/min fil-linja bażi kellhom inċidenza ogħla ta' reazzjonijiet avversi assoċjati ma' tnaqqis fil-volum (eż., sturdament mal-waqqaf, pressjoni baxxa ortostatika, pressjoni baxxa) b'inċidenzi ta' 4.7%, 8.1%, u 1.5% meta kienu fuq canagliflozin 100 mg, canagliflozin 300 mg, u plaċebo, rispettivament (ara sezzjonijiet 4.2 u 4.4).
English: Vulvovaginal candidiasis (including vulvovaginitis and vulvovaginal mycotic infection) was reported in 10.4% and 11.4% of female patients treated with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to 3.2% in placebo-treated female patients.
Maltese: Infezzjonjiet mikotiċi fil-ġenitali Kandidjasi vulvovaġinali (inkluż vulvovaġinite u infezzjoni vulvovaġinali mikotika) kienet irrappurtata f'10.4% u 11.4% tal-pazjenti nisa kkurati b'canagliflozin 100 mg u canagliflozin 300 mg, rispettivament, meta mqabbla ma' 3.2% f'pazjenti nisa kkurati bi plaċebo.
English: Invokana 300 mg film-coated tablets Polyvinyl alcohol
Maltese: Invokana 300 mg pilloli miksijin b'rita Polyvinyl alcohol
English: In general, canagliflozin produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including HbA1c, the percentage of patients achieving HbA1c < 7%, change from baseline fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG).
Maltese: Fil-biċċa l-kbira, canagliflozin ipproduċa riżultati sinifikanti (p < 0.001) b'mod kliniku u statistikament sinifikanti fil kontroll gliċemiku, inkluż HbA1c, il-perċentwal ta' pazjenti li kisbu HbA1c < 7%, bidla mil-linja bażi tal-glukows fil-plażma waqt is-sawm (FPG - fasting plasma glukows), u l-glukows sagħtejn wara ikla (PPG - postprandial glukows) meta mqabbel ma' plaċebo.
English: Invokana 100 mg film-coated tablets Polyvinyl alcohol
Maltese: Invokana 100 mg pilloli miksijin b'rita Polyvinyl alcohol
English: Canagliflozin was studied as monotherapy, dual therapy with metformin, dual therapy with a sulphonylurea, triple therapy with metformin and a sulphonylurea, triple therapy with metformin and pioglitazone, and as an add-on therapy with insulin (table 2).
Maltese: wieħed mis-sulphonylureas, terapija tripla ma' metformin u wieħed mis-sulphonylureas, terapija tripla ma' metformin u pioglitazone, u bħala terapija miżjuda mal-insulina (tabella 2).