FrancophonIA/ELRC3.0 huggingface dataset:
English: Resistance to tetracyclines has also been reported in pig respiratory pathogens (A. pleuropneumoniae, S. suis,) and calf pathogens (Pasteurella spp) in some EU countries.
Maltese: Ir-reżistenza għat-tetracyclines ġiet ukoll irrappurtata fil-patoġeni respiratorji tal-qżieqeż (A. pleuropneumoniae, S. suis) u fil-patoġeni tal-għoġġiela (Pasteurella spp) f'xi pajjiżi tal-UE.
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: Għat-trattament tal-annimali biss - għandu jingħata biss jekk ikun hemm preskrizzjoni veterinarja.
English: Following absorption, tetracyclines are hardly metabolized.
Maltese: Wara li jkun hemm l-assorbiment, it-tetracyclines bilkemm jiġu metabolizzati.
English: In consistency with the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047), the following indications can be agreed:
Maltese: F'konformità mar-riferiment riċenti għallArtikolu 35 għall-qawwiet kollha ta' trab li jinħall fl-ilma u għas-soluzzjonijiet orali li fihom doxycycline hyclate indikati għall-użu fit-tjur u intiżi għall-għoti permezz tal-ilma tax-xorb (EMEA/V/A/047), jista' jsir qbil fuq l-indikazzjonijiet li ġejjin:
English: Doxycycline 50% WSP and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g.
Maltese: Doxycycline 50% WSP u l-ismijiet assoċjati huwa trab għall-użu fl-ilma tax-xorb li fih is-sustanza attiva doxycycline hyclate 500 mg/g.
English: It inhibits bacterial protein synthesis intracellularly by binding on the 30-S ribosome subunits.
Maltese: Tinibixxi s-sintesi intraċellulari tal-proteini filbatterji billi tgħaqqad is-subunitajiet ta' ribosomi 30-S.
English: A pharmacokinetics study demonstrated that when Doxycyline 50% WSP was administered in drinking water to broilers at a dose of doxycycline hyclate of 25 mg/kg body weight/day for 5 days, a steady state plasma doxycycline concentration of 2 μg/ml was reached after 6 hours.
Maltese: Studju farmakokinetiku wera li meta Doxycyline 50% WSP ingħata lill-brojlers fl-ilma tax-xorb f'doża ta' doxycycline hyclate ta' 25 mg/kg tal-piż tal-ġisem/kuljum għal 5 ijiem, intlaħqet konċentrazzjoni fi stat stabbli ta' doxycycline fil-plażma ta' 2 μg/ml wara 6 sigħat.
English: A pharmacokinetic and residues study showed that at a daily dose of 10 mg doxycycline hydrochloride/kg body weight, administered once daily via milk replacer for 5 days, Cmax was achieved within 2 - 3 days with a mean value of 2.2 to 2.5 μg/ml.
Maltese: Studju farmakokinetiku u tar-residwi wera li f'doża ta' kuljum ta' 10 mg doxycycline hydrochloride/kg tal-piż tal-ġisem, li jingħata darba kuljum permezz ta' sostitut talħalib għal 5 ijiem, is-Cmax intlaħaq fi żmien 2 - 3 ijiem b'valur medju ta' 2.2 sa 2.5 μg/ml.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE PP Container
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kontenitur PP
English: No health abnormalities were detected.
Maltese: Ma nstabet l-ebda anormalità fuq is-saħħa.
English: Doxycycline is a broad spectrum antibiotic.
Maltese: Id-doxycycline hija antibijotiku ta' spettru wiesa'.
English: No data were submitted in relation to Haemophilus paragallinarum, Bordetella avium and Clostridia spp infections.
Maltese: Ma ġiet sottomessa l-ebda dejta fir-rigward ta' infezzjonijiet b'Haemophilus paragallinarum, Bordetella avium u Clostridia spp.
English: J Antimicrob.
Maltese: Ipproteġi mill-ġlata.
English: No clinical data were submitted to support use of Doxycyline 50% WSP in the treatment of atrophic rhinitis or bronchopneumonia.
Maltese: L-ebda dejta klinika ma ġiet sottomessa biex tappoġġa l-użu ta' Doxycyline 50% WSP fil-kura tarrinite atrofika jew tal-bronkopnewmonja.
English: Pigs
Maltese: Tjur
English: Benefit Risk assessment
Maltese: Valutazzjoni tar-riskju
English: Not permitted for use in laying birds producing eggs for human consumption.
Maltese: Mhux permess għall-użu fi tjur tal-bidien li jipproduċu bajd għall-konsum mill-bniedem.
English: Non-laying poultry
Maltese: Ħnieżer
English: No clinical or field data have been presented to support use of the product in the treatment of pleuropneumonia (Histophilus somni) or bronchopneumonia involving H. somni, P. multocida, Streptococcus spp or Arcanobacterium pyogenes.
Maltese: L-ebda dejta klinika jew fil-qasam ma ġiet ippreżentata biex tappoġġa l-użu tal-prodott fil-kura ta' plewropnewmonja (Histophilus somni) jew ta' bronkopnewmonja li tinvolvi H. somni, P. multocida, Streptococcus spp jew Arcanobacterium pyogenes.
English: Pre-ruminant calves, pigs, chickens.
Maltese: Għoġġiela, ħnieżer, tiġieġ
English: haemolytica.
Maltese: Għoġġiela
English: A dose of doxycyline hyclate of 25 mg/kg body weight/day in drinking water for 3 days produced decreased mortalities and resolution of clinical signs on all farms except one by the end of treatment.
Maltese: Doża ta' doxycyline hyclate ta' 25 mg/kg tal-piż tal-ġisem/kuljum fl-ilma tax-xorb għal 3 ijiem ipprovdiet nuqqas ta' mwiet u solvien tas-sinjali kliniċi fil-farms kollha ħlief għal wieħed sal-aħħar tal-kura.
English: Water Soluble Powder Cattle (calves), swine, birds
Maltese: Baqar (għoġġiela), ħnieżer, tjur
English: Overdose (symptoms, emergency procedures, antidotes) In calves acute, sometimes fatal myocardial degeneration can occur following singe or multiple dosages.
Maltese: Dożaġġ eċċessiv (sintomi, emerġenza, proċeduri, antidoti) Fil-għoġġiela, jista' jkun hemm deġenerazzjoni mijokardijaka, ġie li fatali, wara li jingħataw dożaġġi singoli jew multipli.
English: Alternatively, the concentrated solution can be used in a proportional water medicator.
Maltese: Alternattivament, is-soluzzjoni konċentrata tista' tintuża f'medikatur tal-ilma proporzjonali.
English: User warnings
Maltese: PARIR SABIEX
English: DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION To be completed nationally
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Jimtela nazzjonalment
English: Pre-ruminant calves: - Bronchopneumonia and pleuropneumonia caused by Pasteurella spp., Streptococcus spp., Arcanobacterium pyogenes, Histophilus somni and Mycoplasma spp.. Pigs: - Atrophic rhinitis caused by Pasteurella multocida and Bordetella bronchiseptica; - Bronchopneumonia caused by Pasteurella multocida, Streptococcus suis and Mycoplasma hyorhinis; - Pleuropneumonia caused by Actinobacillus pleuropneumoniae.
Maltese: Xi dejta mill-qasam ġiet ippreżentata biex tappoġġa l-użu tal-prodott fil-kura tal-pnewmonja kkawżata minn Mycoplasma u P. haemolytica fl-għoġġiela, iżda ma kien hemm l-ebda dejta klinika jew mill-qasam biex tappoġġa l-użu tal-prodott fil-kura ta' plewropnewmonja (H. somni) jew ta' bronkopnewmonja li tinvolvi H. somni, P. multocida, Streptococcus spp jew A. pyogenes.
English: Diergeneesk d., deet Iûs,
Maltese: Diergeneesk d., deet Iûs, afl. 9 (1983)
English: PHARMACEUTICAL PARTICULARS
Maltese: Għamla farmaċewtika
English: 10 mg doxycycline hyclate /kg body weight / day, corresponding to 20 mg of product per kg body weight, for 3-5 consecutive days.
Maltese: 10 mg doxycycline hyclate /kg tal-piż tal-ġisem / jum, jiġifieri daqs 20 mg ta' prodott għal kull kilo ta' piż tal-ġisem, għal 3-5t ijiem wara xulxin.
English: A study showed that Doxycyline hyclaat 50% was well tolerated when administered at the recommended dose of 5 mg doxycycline hyclate/kg body weight/ twice daily for twice the recommended duration (10 days).
Maltese: Studju wera li Doxycyline hyclaat 50% kien ittollerat sew meta ngħata fid-doża rakkomandata ta' 5 mg doxycycline hyclate/kg tal-piż tal-ġisem/ darbtejn kuljum għad-doppju tattul irrakkomandat (10 ijiem).
English: A Good Clinical Practice standard field study was provided investigating the efficacy of Doxycycline 50% WSP to treat naturally occurring outbreaks of colibacillosis on 5 farms in The Netherlands in 1998.
Maltese: Ġie pprovdut studju fil-post tal-Istandards ta' Prattika Klinika Tajba li investiga l-effikaċja ta' Doxycycline 50% WSP fil-kura ta' tifqigħat ta' colibacillosis li seħħew b'mod naturali f'5 irziezet fil-Pajjiżi l-Baxxi fl a
English: Pig
Maltese: Qżieqeż
English: It was accepted that this level of resistance could not be directly extrapolated to doxycycline.
Maltese: Kien aċċettat li dan il-livell ta' reżistenza ma setax jiġi estrapolat direttament għal doxycycline.
English: Pre-ruminant calves: 10 mg doxycycline hyclate /kg body weight / day, corresponding to 20 mg of product per kg body weight, for 3-5 consecutive days, divided over 2 administrations.
Maltese: 10 mg doxycycline hyclate /kg tal-piż tal-ġisem / jum, jiġifieri daqs 20 mg ta' prodott għal kull kilo ta' piż tal-ġisem, għal 3-5t ijiem wara xulxin, maqsum fuq 2 amministrazzjonijiet.
English: There was no clear discrepancy between Member States in the dose regimen of 10 mg doxycycline hyclate/kg body weight for 3 to 5 days.
Maltese: Ma kien hemm l-ebda diskrepanza ċara bejn l-Istati Membri fir-reġimen tad-doża ta' 10 mg doxycycline hyclate/kg tal-piż tal-ġisem għal 3 sa 5 ijiem.
English: The pharmacovigilance data (summary of Periodic Safety Update Reports (PSURs)) from use of the product in chickens covering the past 5 years has been reviewed under the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047).
Maltese: Id-dejta mill-farmakoviġilanza (sommarju tar-Rapport Perjodiku ta' Aġġornament dwar is-Sigurtà (PSURs)) mill-użu tal-prodott fuq it-tiġieġ li kopriet l-aħħar 5 snin ġiet riveduta skont ir-riferiment riċenti għall-Artikolu 35 għall-qawwiet kollha ta' trab li jinħall fl-ilma u għas-soluzzjonijiet orali li fihom doxycycline hyclate indikati għall-użu fit-tjur u intiżi għall-għoti permezz tal-ilma tax-xorb (EMEA/V/A/047).
English: 25 mg doxycycline hyclate /kg body weight / day, corresponding to 50 mg of product per kg body weight, for 3-5 consecutive days.
Maltese: 25 mg doxycycline hyclate /kg tal-piż tal-ġisem / jum, jiġifieri daqs 50 mg ta' prodott għal kull kilo ta' piż tal-ġisem, għal 3-5t ijiem wara xulxin.
English: TARGET SPECIES Pre-ruminant calves, pigs, chickens
Maltese: Għoġġiela, tiġieġ, ħnieżer
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Doxycycline 50 % WSP and associated names, the issue was referred to CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SPC) across the European Union.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti li ttieħdu mill-Istati Membri dwar l-awtorizzazzjoni ta' Doxycycline 50 % WSP u tal-ismijiet assoċjati, il-kwistjoni ġiet riferuta lis-CVMP skont lArtikolu 34(1) tad-Direttiva 2001/82/KE, biex jiġu riżolti d-diverġenzi fost is-Sommarji talKaratteristiċi tal-Prodott (SPC) li huma awtorizzati fuq livell nazzjonali madwar l-Unjoni Ewropea.
English: The pig meat residue depletion data available support a meat withdrawal period of 8 days when pigs are administered 10 mg doxycycline hyclate/kg body weight/day for 5 days.
Maltese: Id-dejta disponibbli dwar it-tneħħija tar-residwi fil-laħam tal-majjali tappoġġa perjodu tal-irtirar ta' 8 ijiem għal-laħam meta l-majjali jingħataw 10 mg doxycycline hyclate/kg tal-piż tal-ġisem/kuljum għal 5 ijiem.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenża, antidoti) jekk ikun hemm bżonn
English: Mean daily water consumption (litre) per animal
Maltese: Konsum nofsi ta' kuljum tal-ilma (litru) għal kull annimal
English: Limited clinical data were provided to support use of the product to treat pleuropneumonia caused by A. pleuropneumoniae, and no clinical or field data were provided to support use of doxycycline in the treatment of atrophic rhinitis or bronchopneumonia in pigs.
Maltese: Id-dejta klinika li ġiet ipprovduta biex tappoġġa l-użu tal-prodott fil-kura ta' plewropnewmonja kkawżata minn A. pleuropneumoniae kienet limitata, u l-ebda dejta klinika jew fil-qasam ma ġiet provduta biex tappoġġa l-użu ta' doxycycline fil-kura tar-rinite atrofika jew ta' bronkopnewmonja fil-majjali.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħrif farmakokinetiċi
English: Calves
Maltese: Majjali
English: Calves, pigs and poultry
Maltese: Għoġġiela, ħnieżer, tjur
English: Water Soluble Powder Pigs
Maltese: Aċdu ċitriku Lattożju
English: • the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; the CVMP has recommended the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxycycline 50% WSP and associated names (see Annex I).
Maltese: Kien hemm dejta dwar xi indikazzjonijiet nieqsa, madankollu, fiż-żmien tar-riferiment għallArtikolu 35, ma kien hemm l-ebda evidenza dokumentata fir-rigward tal-issuspettat nuqqas ta' effikaċja mistenni ta' prodotti b'doxycycline fit-tiġieġ.
English: Residue depletion data in chickens support a meat withdrawal period of 5 days when chicken are administered at 25 mg doxycycline hyclate/kg body weight/day for 5 days.
Maltese: Id-dejta dwar it-tneħħija tar-residwi fil-laħam tat-tiġieġ tappoġġa perjodu tal-irtirar ta' 5 ijiem għal-laħam meta t-tiġieġ jingħataw 25 mg doxycycline hyclate/kg tal-piż tal-ġisem/kuljum għal 5 ijiem.
English: Non-egg laying chickens
Maltese: TAL-PRODOTTI MHUX
English: ATC code: A10BK02.
Maltese: A10BK02.
English: Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium
Maltese: Microcrystalline cellulose Hydroxypropyl cellulose Croscarmellose sodium Magnesium stearate
English: Invokana contains sodium
Maltese: Invokana fih sodium
English: Date of first authorisation: 15 November 2013 Date of latest renewal: 26 July 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2013 Data tal-aħħar tiġdid: 26 ta' Lulju 2018
English: Balanitis or balanoposthitis b,l
Maltese: Balanite jew balanopostite b,l
English: Vulvovaginal candidiasis b,k common
Maltese: Kandidjasi vulvovaġinali b,k komuni
English: • carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
Maltese: • carbamazepine, phenytoin, jew phenobarbital (mediċini li jintużaw biex jikkontrollaw laċċessjonijiet)
English: Placebo (N = 192)
Maltese: Plaċebo (N = 192)
English: • The other ingredients are: tablet core: croscarmellose sodium, hydroxypropyl cellulose, lactose (see section 2 ‘Invokana contains lactose'), magnesium stearate, and microcrystalline cellulose film-coating: macrogol 3350, poly(vinylalcohol), talc, and titanium dioxide (E171).
Maltese: • Is-sustanzi l-oħra huma: qalba tal-pillola: croscarmellose sodium, hydroxypropyl cellulose, lactose (ara sezzjoni 2 ‘Invokana fih lactose'), magnesium stearate, u microcrystalline cellulose kisja tar-rita: macrogol 3350, poly(vinylalcohol), talc u titanium dioxide (E171).
English: In in vitro studies, canagliflozin neither inhibited cytochrome P450 CYP1A2, CYP2A6, CYP2C19, CYP2D6, or CYP2E1, CYP2B6, CYP2C8, CYP2C9, nor induced CYP1A2, CYP2C19, CYP2B6, CYP3A4 at higher than therapeutic concentrations.
Maltese: Fi studji in vitro, canagliflozin la inibixxa CYP1A2, CYP2A6, CYP2C19, CYP2D6, jew CYP2E1, CYP2B6, CYP2C8, CYP2C9, u lanqas induċa CYP1A2, CYP2C19, CYP2B6, CYP3A4 taċ-ċitokroma P450 f'konċentrazzjonijiet ogħla minn dawk terapewtiċi.
English: EU/1/13/884/001 (100 mg - 10x1 film-coated tablets) EU/1/13/884/002 (100 mg - 30x1 film-coated tablets) EU/1/13/884/003 (100 mg - 90x1 film-coated tablets) EU/1/13/884/004 (100 mg - 100x1 film-coated tablets) EU/1/13/884/005 (300 mg - 10x1 film-coated tablets) EU/1/13/884/006 (300 mg - 30x1 film-coated tablets) EU/1/13/884/007 (300 mg - 90x1 film-coated tablets) EU/1/13/884/008 (300 mg - 100x1 film-coated tablets)
Maltese: EU/1/13/884/001 (100 mg - 10 pilloli x1 miksija b'rita) EU/1/13/884/002 (100 mg - 30 pillola x1 miksija b'rita) EU/1/13/884/003 (100 mg - 90 pillola x1 miksija b'rita) EU/1/13/884/004 (100 mg - 100 pillola x1 miksija b'rita) EU/1/13/884/005 (300 mg - 10 pillola x1 miksija b'rita) EU/1/13/884/006 (300 mg - 30 pillola x1 miksija b'rita) EU/1/13/884/007 (300 mg - 90 pillola x1 miksija b'rita) EU/1/13/884/008 (300 mg - 100 pillola x1 miksija b'rita)
English: Medicinal product/Laboratory test interference
Maltese: Interferenza bejn il-prodott mediċinali/t-test tal-laboratorju
English: Elderly (≥ 65 years old) Renal function and risk of volume depletion should be taken into account (see section 4.4).
Maltese: Anzjani (≥ 65 sena) Il-funzjoni tal-kliewi u r-riskju ta' tnaqqis fil-volum għandhom jitqiesu (ara sezzjoni 4.4).
English: Severe allergic reaction (rare, may affect up to 1 in 1,000 people) Possible signs of severe allergic reaction may include:
Maltese: Reazzjoni allerġika severa (rari, tista' taffettwa sa persuna waħda minn kull 1,000) Sinjali possibbli ta' reazzjoni allerġika jistgħu jinkludu:
English: Effects of other medicinal products on canagliflozin
Maltese: Effetti ta' prodotti mediċinali oħra fuq canagliflozin
English: Renal Endpoints
Maltese: Skopijiet Finali Renali
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma ddefiniti skont ilkonvenzjoni li ġejja: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Add-on therapy with insulin d (18 weeks) Canagliflozin + insulin
Maltese: Terapija miżjuda mal-insulina d (18-il ġimgħa) Canagliflozin + insulina
English: If interrupted, consideration should be given to more frequent glucose monitoring.
Maltese: Jekk jitwaqqaf, għandu jitqies monitoraġġ aktar frekwenti talglukows.
English: Dyslipidemia m, Haematocrit increased b,n uncommon
Maltese: Dislipidemija m, Żieda fl-ematokrit b,n mhux komuni
English: Invokana 100 mg tablets Invokana 300 mg tablets canagliflozin
Maltese: Invokana 100 mg pilloli Invokana 300 mg pilloli canagliflozin
English: Table 4: Efficacy results from active-controlled clinical studies Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin Glimepiride (titrated) + metformin (N = 482)
Maltese: Tabella 4: Riżultati ta' effikaċja minn studji kliniċi kkontrollati b'mod attiv Imqabbel ma' glimepiride bħala terapija doppja ma' metformin (52 ġimgħa) Canagliflozin + metformin Glimepiride (titrat) + metformin (N = 482)
English: For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5, and 5.1.
Maltese: Għar-riżultati tal-istudji dwar kombinazzjonijiet ta' terapiji, effetti fuq il-kontroll gliċemiku u avvenimenti kardjovaskulari, u l-popolazzjonijiet studjati, ara sezzjonijiet 4.4, 4.5, u 5
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and medicinal product-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (AUC) and peak concentration (Cmax) were observed.
Maltese: Wara għoti ta' canagliflozin ma' rifampicin (induttur ta' diversi trasportaturi attivi u enzimi li jimmetabolizzaw il-prodott mediċinali), kien osservat tnaqqis ta' 51% u 28% fl-esponiment sistemiku (AUC) għal canagliflozin u l-ogħla konċentrazzjoni (Cmax) ta' canagliflozin.
English: Incidence rate (per 100 subject-years) 0.34 HR (95% CI) vs. placebo Minor Amputation, n (%) Major Amputation, n (%)
Maltese: HR (95% CI) vs. plaċebo Amputazzjoni Żgħira, n (%) Aputazzjoni Kbira, n (%)
English: , Blood potassium increased b,q
Maltese: , Żieda fil-potassium fid-demm b,q
English: Patients (%) achieving HbA1c < 7% Fasting Plasma Glucose (mg/dL) Baseline (mean)
Maltese: Pazjenti (%) li kisbu HbA1c < 7% Glukożju fil-Plażma waqt is-Sawm (mg/dL) Linja bażi (medja)
English: If Fournier's gangrene is suspected, Invokana should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Invokana għandu jitwaqqaf u jinbeda trattament fil-pront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: The 100 mg tablet also contains iron oxide yellow (E172).
Maltese: Il-pillola ta' 100 mg fiha wkoll iron oxide isfar (E172).
English: Table 3: Efficacy results from placebo-controlled clinical studies Monotherapy (26 weeks) Canagliflozin
Maltese: Tabella 3: Riżultati ta' effikaċja minn studji kliniċi kkontrollati bi plaċebo Monoterapija (26 ġimgħa) Canagliflozin
English: In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m 2 to < 60 mL/min/1.73 m 2 were evaluated.
Maltese: Fil-programm ta' żvilupp kliniku, kienu evalwati 1,085 pazjent b'eGFR minn 30 mL/min/1.73 m2 sa < 60 mL/min/1.73 m2 fil-linja bażi.
English: EU/1/13/884/005 (10 film-coated tablets) EU/1/13/884/006 (30 film-coated tablets) EU/1/13/884/007 (90 film-coated tablets) EU/1/13/884/008 (100 film-coated tablets)
Maltese: EU/1/13/884/005 (10 pilloli miksija b'rita) EU/1/13/884/006 (30 pillola miksija b'rita) EU/1/13/884/007 (90 pillola miksija b'rita) EU/1/13/884/008 (100 pillola miksija b'rita)
English: Canagliflozin has not been studied in severe renal impairment (eGFR < 30 mL/min/1.73 m 2 or CrCl < 30 mL/min) or ESRD.
Maltese: Canagliflozin ma ġiex studjat f'indeboliment qawwi tal-kliewi (eGFR < 30 mL/min/1.73 m 2 jew CrCl < 30 mL/min) jew ESRD.
English: Table 2: Integrated Analysis of Amputations in CANVAS AND CANVAS-R Placebo
Maltese: Tabella 2: Analiżi Integrata ta' Amputazzjonijiet f'CANVAS u CANVAS-R Plaċebo N = 4344
English: Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Maltese: Kull pillola fiha anqas minn 1 mmol sodium (23 mg), u hija essenzjalment mingħajr sodium.
English: C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and 3.2% of the administered radioactive dose was recovered in faeces as canagliflozin, a hydroxylated metabolite, and an O-glucuronide metabolite, respectively.
Maltese: C]canagliflozin mill-ħalq lil individwi f'saħħithom, 41.5%, 7.0%, u 3.2% tad-doża radjuattiva mogħtija ġew irkuprati fl-ippurgar bħala canagliflozin, metabolit idroksilat, u metabolit O-glukuronajd, rispettivament.
English: Diabetic ketoacidosis b,h
Maltese: Ketoaċidożi tad-dijabete b,h
English: The racial distribution was 72% White, 16% Asian, 5% Black, and 8% other groups.
Maltese: Iddistribuzzjoni tar-razez kienet 72% Bojod, 16% Asjatiċi, 5% Suwed, u 8% gruppi oħra. 17% talpazjenti kienu ta' dixxendenza Spanjola. 58% tal-pazjenti kienu rġiel.
English: A total of 714 patients ≥ 55 years of age to ≤ 80 years of age (227 patients 65 years of age to < 75 years of age and 46 patients 75 years of age to ≤ 80 years of age) with inadequate glycaemic control on current diabetes treatment (glucose-lowering medicinal products and/or diet and exercise) participated in a double-blind, placebo-controlled study over 26 weeks.
Maltese: Total ta' 714-il pazjent li kellhom ≥ 55 sena sa ≤ 80 sena (227 pazjent b'età minn 65 sena sa < 75 sena u 46 pazjent b'età minn 75 sena sa < 80 sena) b'kontroll ġliċemiku mhux xieraq bil-kura attwali taddijabete (prodotti mediċinali li jbaxxu l-glukows u/jew dieta u eżerċizzju) pparteċipaw fi studju double-blind ikkontrollat bi plaċebo fuq perjodu ta' 26 ġimgħa.