FrancophonIA/ELRC3.0 huggingface dataset:
English: A harmonised dosing regimen to be used in adult horses is proposed, that conforms to the desired PK/PD characteristics of a concentration-dependent antibiotic and reflects data available in horses.
Maltese: Ġiet proposta skema ta' dożaġġ armonizzata li għandha tintuża fiż-żwiemel adulti, li hija konformi malkaratteristiċi PK/PD mixtieqa għal antibijotiku li jiddependi fuq il-konċentrazzjoni u li tirrifletti d-data disponibbli fiż-żwiemel.
English: Gentamicin 50
Maltese: Ġentamiċina 50
English: Horse, foal, cattle, calf, pig, dog, cat
Maltese: Żwiemel, moħor, frat, għoġġiela, ħnieżer, klieb, qtates
English: Belgium Franklin Pharmaceuticals Ltd. Athboy Road
Maltese: Il-Belġju Franklin Pharmaceuticals
English: Spain Franklin Pharmaceuticals Ltd. Athboy Road
Maltese: Spanja Franklin Pharmaceuticals
English: The substance is highly polar, hydrophilic and transport appears to be an active process closely linked to electron transport, oxidative phosphorylation and the respiratory quinones in the cell membrane.
Maltese: Is-sustanza hija ferm polari, idrofilika u t-trasport jidher li huwa proċess attiv marbut mill-qrib mattrasport tal-elettroni, fosforilazzjoni ossidattiva u l-kinoni respiratorji fil-membrana taċ-ċellula.
English: The CVMP notes that pursuant to Article 36 of the Directive, its obligation is to consider the matter concerned and issue a reasoned opinion within the appropriate time limit.
Maltese: Is-CVMP jinnota li skont l-Artikolu 36 tad-Direttiva, l-obbligu tiegħu huwa li jqis il-kwistjoni kkonċernata u li jagħti opinjoni raġunata fi żmien il-limitu ta' żmien xieraq.
English: The relatively low approved dose and the target pathogens indicated for Gentaject 10% solution for injection gave grounds for Denmark to be concerned as to whether the proposed indications and dosage regimen for this product are supported by adequate data, given evidence from recent scientific publications.
Maltese: Id-doża relattivament baxxa approvata u l-patoġeni fil-mira indikati għal Gentaject 10% taħlita likwida għall-injezzjoni taw lid-Danimarka raġunijiet għal tħassib dwar jekk l-indikazzjonijiet u l-iskema ta' dożaġġ proposta għal dan il-prodott humiex appoġġjati minn data xierqa, fid-dawl tal-evidenza minn pubblikazzjonijiet xjentifiċi reċenti.
English: Dog, cat, pig, piglets, cattle, calves, horses
Maltese: Ħnieżer, qtates, frat, klieb, żwiemel
English: Ireland Franklin Pharmaceuticals Ltd. Athboy Road
Maltese: L-Irlanda Franklin Pharmaceuticals
English: The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive for the following indication: “For the treatment of infections of the lower respiratory tract in horses caused by Gram-negative bacteria susceptible to gentamicin.”
Maltese: Is-CVMP qies li l-bilanċ tal-benefiċċju-riskju għal prodotti mediċinali veterinarji injettabbli li fihom ġentamiċina għaż-żwiemel huwa pożittiv għall-indikazzjoni li ġejja: “Għall-kura ta' infezzjonijiet tal-passaġġ respiratorju t'isfel fiż-żwiemel ikkawżati minn batterji Gramnegattivi suxxettibbli għal ġentamiċina.
English: O-Adenyltransferases (ANT) - catalyses ATP-dependent adenylation of hydroxyl group
Maltese: O-Adenyltransferases (ANT) - jikkatalizza l-adenylation dipendenti fuq l-ATP ta' grupp talidroksil 3. O-Phosphotransferases (APH) - jikkatalizza l-fosforilazzjoni dipendenti fuq l-ATP ta' grupp talidroksil Żewġ mekkaniżmi oħra ta' reżistenza jinkludu mutazzjonijiet ribosomali tas-sit ta' rbit talaminoglikosidi, is-sottounità 30S, u l-batterji li jnaqqsu l-permeabilità tal-aminoglikosidi.
English: Strength Pharmaceutical form
Maltese: Grupp farmako-terapewtiku:
English: In one mechanism, gentamicin can interfere with the correct amino acid polymerisation and elongation.
Maltese: F'mekkaniżmu wieħed, ġentamiċina jista' jinterferixxi mal-polimerizzazzjoni u l-elongazzjoni tal-aċidu amminiku korrett.
English: Latvia Bela-pharm GmbH & Co.KG Lohner Str. 19
Maltese: Bela-Pharm GmbH & Co.
English: Gentamicin is primarily distributed within extracellular fluids.
Maltese: Ġentamiċina jiġi primarjament distribwit fil-fluwidi ekstraċellulari.
English: During this MRP Denmark noted that the originator and the generic products have different indications and dosing regimens.
Maltese: Matul dan l-MRP id-Danimarka nnotat li l-oriġinatur u l-prodotti ġeneriċi għandhom indikazzjonijiet u skemi ta' dożaġġ differenti.
English: Dosing regimen
Maltese: Skema tad-dożaġġ
English: Extra caution is advised if using gentamicin in old horses, or with fever, endotoxemia, sepsis and dehydration.
Maltese: Huwa rakkomandat li tintuża kawtela addizzjonali jekk ġentamiċina ikun se jintuża fuq żwiemel xjuħ, jew bid-deni, b'endotoxemia, b'sepsis u b'deidrazzjoni.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali veterinarji li fihom ġentamiċinaġentamiċina ppreżentati bħala taħlita ta' likwidi għall-injezzjoni biex jingħataw liż-żwiemel (ara Anness I)
English: The CVMP considered that the lack of data and limited scientific evidence would only support a narrow indication, i.e. “For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.”
Maltese: Is-CVMP qies li n-nuqqas ta' data u l-evidenza xjentifika limitata tappoġġja biss indikazzjoni dejqa, jiġifieri “Għall-kura ta' infezzjonijiet tal-passaġġ respiratorju t'isfel fiż-żwiemel ikkawżati minn batterji aerobiċi Gramnegattivi suxxettibbli għal ġentamiċina.
English: Gentamicin does not have effects on anaerobe bacteria and mycoplasmas.
Maltese: Ġentamiċina m'għandux effetti fuq il-batterji anaerobe u lmikoplasmi.
English: Horse, foal, cattle, calf, pig, piglet, weaner, dog and cat
Maltese: Klieb, qtates, ħnieżer, ħnieżer żgħar, frat, għoġġiela, żwiemel
English: Gentamicin is de-activated in the presence of inflammatory debris, low oxygen environments and low pH.
Maltese: Ġentamiċina jiġi diżattivat filpreżenza ta' debris infjammatorju, f'ambjenti b'livell baxx ta' ossiġenu u pH baxx.
English: Bovine, equine, pigs, dogs and cats
Maltese: Bovini, ekwini, ħnieżer, klieb u qtates
English: Harjumaa
Maltese: IlĠermanja
English: Pharmacokinetics of gentamicin change considerably in the first 2 weeks of a foal's life - plasma concentrations of gentamicin are more difficult to achieve in neonatal foals and gentamicin is retained longer in the body, especially kidneys, compared to adults leading to a higher likelihood of gentamicin-induced nephrotoxicity.
Maltese: Il-farmakokinetika ta' ġentamiċina tinbidel konsiderevolment fl-ewwel ġimagħtejn tal-ħajja ta' moħor - il-konċentrazzjonijiet ta' ġentamiċina fil-plasma huma aktar diffiċli jintlaħqu f'moħor tat-twelid u ġentamiċina jinżamm għal żmien itwal fil-ġisem, speċjalment fil-kliewi, meta mqabbla mal-adulti li dan iwassal għal probabbiltà ogħla ta' nefrotossiċità kkawżata minn ġentamiċina.
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Maltese: *Qawwa Relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li ntweriet li hija effikaċi fil-baqar.
English: Intramuscular Type II hydrolytic glass vial with butyl stopper and aluminium seal
Maltese: Kunjett ta' ħġieġ idrolitiku Tip II b'tapp tal- butyl u siġill talaluminju.
English: Intramuscular Type I hydrolytic glass vial with butyl stopper and aluminium seal.
Maltese: Kunjett ta' ħġieġ idrolitiku Tip I b'tapp tal- butyl u siġill talaluminju.
English: Package size
Maltese: Kontenut Daqs talpakkett
English: EMA/496403/2010 EMEA/H/C/000403
Maltese: EMEA/H/C/000403
English: Other information about Arixtra:
Maltese: Informazzjoni oħra dwar Arixtra:
English: The marketing authorisation holder is Glaxo Group Ltd.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Glaxo Group Ltd.
English: Arixtra contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Maltese: Arixtra fih is-sustanza attiva fondaparinux sodium (1.5, 2.5, 5, 7.5 jew 10 mg f'kull siringa).
English: This document is a summary of the European public assessment report (EPAR) for Arixtra.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Arixtra.
English: Arixtra is an anticoagulant: it prevents the blood from coagulating (clotting).
Maltese: Arixtra huwa antikoagulant; huwa jipprevjeni d-demm milli jagħqad (clotting).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arixtra on 21 March 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Arixtra fil-21 ta' Marzu 2002.
English: What is Arixtra?
Maltese: X'inhu Arixtra?
English: Why has Arixtra been approved?
Maltese: Għaliex ġie approvat Arixtra?
English: In the study of myocardial infarction with ST segment elevation, Arixtra reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care.
Maltese: Fl-istudju ta' infarti mijokardjali b'elevazzjoni tas-segment ST, Arixtra naqqas ir-riskju ta' mewt jew attakk tal-qalb ieħor b'14% wara 30 jum, meta mqabbel mal-kura standard.
English: In the prevention studies, Arixtra was compared with other anticoagulants: enoxaparin (in hip or knee surgery; over 8,000 patients) or dalteparin (in abdominal surgery; 2,927 patients).
Maltese: Fl-istudji dwar il-prevenzjoni, arixtra tqabbel ma' antikoagulanti oħrajn: Enoxaparin (f'operazzjoni tal-ġenbejn jew l-irkoppa; aktar minn 8,000 pazjent) jew dalteparin (f'operazzjoni addominali; 2,927 pazjent).
English: Arixtra (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems due to the formation of blood clots in the veins) in adults (aged 18 years or over) who are having major surgery to their legs, such as a hip or knee surgery.
Maltese: Arixtra (dożaġġi ta' 1.5 u 2.5 mg) jintuża għall-prevenzjoni ta' episodji tomboemboliċi venużi (VTEs, problemi minħabba l-formazzjoni ta' għoqod tad-demm fil-vini) f'adulti (minn 18-il sena 'l fuq) li jkunu ser jagħmlu operazzjoni serja f'riġlejhom, bħal operazzjoni tal-ġenb jew l-irkoppa.
English: How has Arixtra been studied?
Maltese: Kif ġie studjat Arixtra?
English: The active ingredient in Arixtra, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, factor Xa.
Maltese: Is-sustanza attiva f'Arixtra, fondaparinux sodium, twaqqaf waħda mis-sustanzi (fatturi) li huma involuti fil-koagulazzjoni tad-demm, il-fattur Xa.
English: What is the risk associated with Arixtra?
Maltese: X'inhu r-riskju assoċjat ma' Arixtra?
English: In the prevention of VTEs, the recommended dose of Arixtra is 2.5 mg once a day by subcutaneous injection (under the skin).
Maltese: Fil-prevenzjoni ta' VTEs, id-doża rakkomandata ta' Arixtra hija ta' 2.5 mg darba kuljum amministrata permezz ta' injezzjoni taħt il-ġilda (subcutaneous injection).
English: At higher strengths (5, 7.5 and 10 mg), Arixtra is used to treat DVT or pulmonary embolism (PE, clot in a blood vessel supplying the lungs).
Maltese: F'dożaġġi aktar għoljin (5, 7.5 u 10 mg), Arixtra jintuża għall-kura ta' DVT jew emboliżmu pulmonari (PE, għoqda f'arterja tad-demm li tissupplixxi l-pulmuni).
English: Arixtra has been studied for the prevention of and in the treatment of VTE.
Maltese: Arixtra ġie studjat għall-prevenzjoni u l-kura ta' VTE.
English: It was also compared with placebo (a dummy treatment) when looking at patients with an acute illness (839 patients) and patients treated for an additional 24 days following hip fracture surgery (656 patients).In the treatment of VTE such as DVT and PE, Arixtra was compared with enoxaparin (DVT: 2,192 patients) or with unfractionated heparin (PE: 2,184 patients).
Maltese: Fil-kura ta' VTE bħal DVT u PE, Arixtra tqabbel ma' enoxaparin (DVT: 2,192 pazjent) jew ma' eparina mhux frazzjonata (PE: 2,184 pazjent).
English: Arixtra (1.5 and 2.5 mg strengths) is also used to treat adults who have blood clots in the superficial veins of the legs (superficial venous thrombosis) but not in their deep veins (deep vein thrombosis, DVT).
Maltese: Arixtra (dożaġġi ta' 1.5 u 2.5 mg) jintuża wkoll għall-kura ta' adulti li għandhom għoqod tad-demm filvini superfiċjali tar-riġlejn (trombożi venuża superfiċjali) iżda mhux fil-vini fondi tagħhom (trombożi tal-vini fondi, DVT).
English: The first compared the effects of Arixtra with those of enoxaparin in over 20,000 patients with unstable angina or myocardial infarction without ST segment elevation, and the second compared Arixtra with standard care (unfractionated heparin in eligible patients, or placebo) in over 12,000 patients with myocardial infarction with ST segment elevation.
Maltese: L-ewwel wieħed qabbel l-effetti ta' Arixtra ma dawk ta' enoxaparin f'aktar minn 20,000 pazjent li jbatu minn anġina mhux stabbli jew infart mijokardjali mingħajr elevazzjoni tas-segment ST, u t-tieni wieħed qabbel Arixtra mal-kura standard (eparina mhux frazzjonata f'pazjenti eliġibbli, jew plaċebo) f'aktar minn 12,000 pazjent li jbatu minn infart mijokardjali b' elevazzjoni tas-segment ST.
English: Arixtra was at least as effective as enoxaparin in preventing death or an ischaemic event in patients with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days.
Maltese: Arixtra kien mill-inqas effettiv daqs enoxaparin fil-prevenzjoni tal-mewt jew avveniment iskaemiku f'pazjenti li jbatu minn anġina mhux stabbli jew infart mijokardjali mingħajr elevazzjoni tas-segment ST, b'madwar 5% tal-pazjenti f'kull grupp li mietu jew li kellhom avveniment iskaemiku wara disat ijiem.
English: The main measure of effectiveness was the proportion of patients who died or had an ‘ischaemic event' (restriction of blood supply to an organ, including the heart).
Maltese: Ilkejl ewlieni ta' effikaċja kienet il-proporzjon ta' pazjenti li mietu jew kellhom ‘avveniment iskaemiku' (restrizzjoni tal-provvista tad-demm lejn xi organu, inkluża l-qalb).
English: For more information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju tal-karatteristiċi tal-prodott (ukoll parti mill-EPAR).
English: For the full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijet, ara l-Fuljett ta' Tagħrif.
English: The overall rate of thrombotic events in patients treated with Arixtra was significantly less than in patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin.
Maltese: Ir-rata globali ta' avvenimenti trombotiċi f'pazjenti kkurati b'Arixtra kienet sinifikament inqas minn dik f'pazjenti kkurati bi plaċebo jew b'enoxaparin (għal pazjenti li kienu se jiġu operati fir-riġlejn), u kienet simili għal dik b'enoxaparin (trattament ta' DVT), dalteparin jew eparina mhux frazzjonata.
English: Treatment should be started as soon as possible following exclusion of DVT, and should be continued for between 30 and 45 days.
Maltese: Il-kura għandha tinbeda malajr kemm jista' jkun wara l-esklużjoni ta' DVT, u għandha titkompla bejn 30 u 45 jum.
English: In the treatment of superficial vein thrombosis, Arixtra was compared with placebo in one study of 3,000 patients with superficial vein thrombosis of the legs, without DVT.
Maltese: Fil-kura ta' trombożi tal-vini superfiċjali, arixtra tqabbel ma' plaċebo fi studju wieħed ta' 3,000 pazjent bi trombożi tal-vini superfiċjali tar-riġlejn, mingħajr DVT.
English: Arixtra was more effective than placebo in reducing the overall occurrence of VTE or death in patients with superficial vein thrombosis.
Maltese: Arixtra kien aktar effettiv minn plaċebo it-tnaqqis tal-okkorrenza ġenerali ta' VTE jew mewt f'pazjenti bi trombożi tal-vini superfiċjali.
English: The 2.5 mg strength is also used to treat adults with unstable angina (a type of chest pain that changes in severity due to reduced blood flow to the heart) or who are having a myocardial infarction (heart attack) with or without ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG).
Maltese: Għall-pazjenti li jbatu minn anġina mhux stabbli jew infarti mijokardjali, id-doża rakkomandata hija ta' 2.5mg darba kuljum b' injezzjoni taħt il-ġilda, imma l-ewwel doża trid tingħata ġo vina (intravenously) permezza ta' linja eżistenti jew bħala infużjoni (dripp) fil-pazjenti li għandhom elevazzjoni tas-segment ST.
English: By using Arixtra after surgery, the risk of a blood clot forming is greatly reduced.
Maltese: Bl-użu ta' Arixtra wara operazzjoni, ir-riskju ta' formazzjoni ta' għoqod tad-demm jitnaqqas drastikament.
English: In the treatment of superficial vein thrombosis, the recommended dose is 2.5 mg once a day by subcutaneous injection.
Maltese: Fil-kura ta' trombożi tal-vini superfiċjali, id-doża rakkomandata hija ta' 2.5 mg darba kuljum b'injezzjoni taħt il-ġilda.
English: In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots).
Maltese: Fl-istudji kollha, il-mezz prinċipali ta' effikaċja kien ir-rata globali ta' avvenimenti trombotiċi (problemi kkawżati minn għoqod fid-demm).
English: In the treatment of DVT or PE, the recommended dose is 7.5 mg once a day by subcutaneous injection, usually for seven days.
Maltese: Fil-kura ta' DVT jew PE, id-doża rakkomandata hija ta' 7.5 mg darba kuljum mogħtija b' injezzjoni taħt il-ġilda, normalment għal sebat ijiem.
English: Erythema3 Urticaria3
Maltese: Eritema3 Urtikarja3
English: • if you are going to have an operation under anaesthesia.
Maltese: • jekk inti se jkollok operazzjoni taħt anesteżija.
English: Gastrointestinal symptoms3, 5
Maltese: Sintomi gastro-intestinali3,
English: N SBP (mmHg)3
Maltese: SBP (mmHg)3
English: Vitamin B12 deficiency3, 4
Maltese: vitamina B123,
English: Difference from glimepiride1 (97.5% CI)
Maltese: Differenza minn glimepiride1 (97.5% CI) N
English: Insulin dose (IU/day)
Maltese: N Doża tal-insulina (IU/jum)
English: Difference from placebo1
Maltese: Differenza mill-plaċebo1
English: Add-on to pioglitazone + metformin therapyb Placebo
Maltese: Terapija aġġuntiva ma' pioglitazone + metforminb Plaċebo
English: • Diabetic ketoacidosis, diabetic pre-coma.
Maltese: • Ketoaċidożi dijabetika, prekoma dijabetika.
English: Lactic acidosis.
Maltese: Aċidożi lattika.
English: Placebo empagliflozin
Maltese: Sintomi Empagliflozin
English: Hypoglycaemia (when used with sulphonylurea or insulin)1
Maltese: sulphonylurea jew mal-insulina)1
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Maltese: Il-plażma fl-istat fiss medju AUC u Cmax kienu ta' 1870 nmol/l u 259 nmol/l b'empagliflozin 10 mg u 4740 nmol.h u 687 nmol/l b'empagliflozin
English: Signs of ‘lactic acidosis' are:
Maltese: Is-sintomi ta' “aċidożi lattika” huma:
English: Increased urination1, 2
Maltese: Infezzjoni tal-passaġġ urinarju1, 2
English: • Renal failure or renal dysfunction (creatinine clearance <60 ml/min).
Maltese: • Insuffiċjenza tal-kliewi jew disfunzjoni tal-kliewi (tneħħija tal-krejatinina < 60 ml/min)
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Maltese: Il-konsum ta' alkoħol u prodotti mediċinali li fihom l-alkoħol għandu jiġi evitat.
English: In the acute conditions listed, metformin should be temporarily discontinued.
Maltese: Fil-kundizzjonijiet akuti elenkati, metformin għandu jitwaqqaf temporanjament.
English: HbA1c <7% with baseline HbA1c ≥7% at week 52b, 2
Maltese: b'HbA1cfil-linja bażi ≥ 7% f'Ġimgħa 52b, 2
English: * p-value <0.0001 ** p-value ≤0.025
Maltese: * valur p < 0.0001 ** valur p ≤ 0.025
English: Further symptoms are reduced body temperature and heart beat.
Maltese: Sintomi oħrajn jinkludu tnaqqis fit-temperatura tal-ġisem u t-taħbit tal-qalb.
English: How to take Synjardy
Maltese: Mediċini oħra u Synjardy
English: 90 x 1 film-coated tablets.
Maltese: 90 x 1 pillola miksija b'rita.
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Maltese: Pazjenti (%) li jiksbu HbA1c < 7%
English: Liver function tests abnormalities3 Hepatitis3
Maltese: Anormalitajiet fit-testijiet tal-funzjoni tal-fwied3
English: 1 LOCF, values after taking antidiabetic rescue therapy censored
Maltese: 1 LOCF, valuri wara terapija ta' salvataġġ kontra d-dijabete ċċensurati
English: In patients 75 years and older, an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8).
Maltese: 75 sena u aktar, riskju ogħla għal żvojtar ta' volum għandu jiġi kkonsidrat (ara sezzjonijiet 4.4 u 4.8).
English: N HbA1c (%) at week 52b
Maltese: HbA1c (%) f'Ġimgħa 52b
English: For metformin, AUC decreased by 12% and Cmax decreased by 26% compared to fasting conditions.
Maltese: Għal metformin, l-AUC naqas bi 12% u s Cmax naqas b'26%
English: ** p-value <0.001
Maltese: ** valur p < 0.0001
English: ketoacidosisa, b Lactic acidosis3
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Following administration of a dose of 850 mg metformin hydrochloride, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 minute prolongation of the time to peak plasma concentration were observed.
Maltese: metformin hydrochloride 850 mg, kienu osservati konċentrazzjoni massima fil-plażma aktar baxxa b'40%, tnaqqis ta' 25% fl-AUC u dewmien ta' 35 minuta tal-ħin biex tintlaħaq l-ogħla konċentrazzjoni fil-plażma.
English: a derived from postmarketing experience b see section 4.4
Maltese: a derivata mill-esperjenza ta' wara t-tqegħid fis-suq b ara sezzjoni 4.4
English: Empagliflozin as add-on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone and metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 2).
Maltese: Empagliflozin bħala terapija aġġuntiva ma' metformin, metformin u sulphonylurea, jew pioglitazone u metformin irriżulta fi tnaqqis statistikament sinifikanti (p< 0.0001) fl-HbA1c u fil-piż tal-ġisem meta mqabbel ma' plaċebo (Tabella 2).
English: Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-dministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Maltese: sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide u hydrochlorthiazide.
English: Renal clearance of metformin is >400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Maltese: Eliminazzjoni L-eliminazzjoni mill-kliewi ta' metformin hija > 400 ml/min, u dan jindika li metformin jitneħħa permezz ta' filtrazzjoni glomerulari u sekrezzjoni tubulari.
English: * p-value <0.0001 ** p-value <0.01
Maltese: * valur p < 0.0001 ** valur p < 0.01
English: 100 x 1 film-coated tablets.
Maltese: 100 x 1 pillola miksija b'rita.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Maltese: (≥ 1/10,000 sa < 1/1,000), jew rari ħafna (< 1/10,000), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).