FrancophonIA/ELRC3.0 huggingface dataset:
English: • Drinking alcohol with TRITAZIDE may make you feel dizzy or light-headed.
Maltese: • Ix-xorb alkoħoliku ma TRITAZIDE jista' jagħmlek sturdut.
English: Ramipril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors).
Maltese: Ramipril jagħmel parti minn grupp ta' mediċini li jissejħu inibituri ta' ACE (Inibituri ta' l-Enzima li Tikkonverti Angiotensin).
English: Transient erectile impotence
Maltese: Impotenza erettili għal żmien qasir
English: • Blood tests showing a change in the amount of salts such as sodium, calcium, magnesium and chloride in your blood
Maltese: • Testijiet tad-demm juru tibdil fl-ammont ta' mluħa bħal sodju, kalċju, magnesju u klorju fid demm tiegħek.
English: This could be a sign of a severe allergic reaction to TRITAZIDE
Maltese: Dan jista' jkun sinjal ta' reazzjoni allerġika serja għal TRITAZIDE
English: Take the medicine pack with you.
Maltese: Ħu l-pakkett tal-mediċina miegħek.
English: • Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform).
Maltese: • Reazzjonijiet tal-ġilda serji fosthom raxx, ulċeri f'ħalqek, iggravar ta' mard tal-ġilda diġà eżistenti, ħmura, bżieżaq jew stakkar tal-ġilda (bħal sindromu ta' Stevens-Johnsons, nekroliżi tossika tal-ġilda jew eritema multiforma).
English: • Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline.
Maltese: • Mediċini li jintużaw għall-kura tal-pressjoni baxxa, xokk, insuffiċjenza kardijaka, ażma jew allerġiji bħal ephedrine, noradrenaline jew adrenaline.
English: Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia.
Maltese: Ġie muri li thiazides iżidu t-tneħħija fl-awrina ta' magnesium, li jista' jirriżulta f'ipomagnesimja.
English: Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in: - patients with severe hypertension - patients with decompensated congestive heart failure - patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve) - patients with unilateral renal artery stenosis with a second functional kidney - patients in whom fluid or salt depletion exists or may develop (including patients with diuretics) - patients with liver cirrhosis and/or ascites - patients undergoing major surgery or during anaesthesia with agents that produce hypotension.
Maltese: Għandha tkun mistennija attivazzjoni sinifikanti fis-sistema renin-anġjotensin-aldosterone u tkun neċessarja superviżjoni medika li tinkludi monitoraġġ talpressjoni tad-demm, per eżempju f': - pazjenti b'ipertensjoni severa - pazjenti b'insuffiċjenza tal-qalb konġestiva ddekompensata - pazjenti b'impediment fid-dħul u fil-ħruġ tad-demm mill-ventriklu tax-xellug li b'mod emodinamiku jkun rilevanti (eż. djuqija tal-valvola aortika jew mitrali - pazjenti b'djuquja f'arterja renali waħda b'kilwa l-oħra li tiffunzjona - pazjenti fejn jeżisti jew jista' jiżviluppa nuqqas ta' fluwidu jew melħ (inklużi pazjenti fuq d-dijuretiċi) - pazjenti b'ċirrożi tal-fwied jew axxite - pazjenti li se jagħmlu xi operazzjoni kbira jew waqt l-anesteżija b'sustanzi li jikkawża lipotensjoni Normalment, qabel ma tinbeda l-kura, hu rakkomandat li tiġi rregolarizzata d-deidratazzjoni, lipovolimja u n-nuqqas ta' melħ (madankollu, f'pazjenti b'insuffiċjenza tal-qalb, trid toqgħod attent li b'din l-azzjoni korrettiva ma jkunx hemm ir-riskju li l-volum jiżdied iżżejjed).
English: • Breast enlargement in men
Maltese: • Testijiet tad-demm li juru anqas potassju mis-soltu fid-demm tiegħek
English: SANOFI-AVENTIS OY Huopalahdentie 24 00350 Helsinki Finland
Maltese: SANOFI-AVENTIS OY Huopalahdentie 24
English: Vomiting, aphtous stomatitis, glossitis, diarrhoea, abdominal pain upper, dry mouth
Maltese: Rimettar, ulċeri filħalq, glossite, dijarea, uġigħ finnaħa ta' fuq taladdome, ħalq xott
English: They are extended with the contraindications of HCTZ.
Maltese: Dawn huma estiżi mal-kontraindikazzjonijiet ta' HCTZ.
English: Surgery
Maltese: Operazzjoni
English: When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Jekk tiġi dijanjostikata ttqala, il-kura bl-inibituri ACE/AIIRAs għandu jitwaqqaf minnufih, u jekk ikun hemm bżonn, tinbeda kura alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: Hyperkalaemia
Maltese: Iperkalċimja
English: Hydrochlorothiazide, in cases of prolonged exposure during the third trimester of pregnancy, may cause a foeto-placental ischaemia and risk of growth retardation.
Maltese: F'każijiet ta' espożizzjoni għal żmien twil waqt it-tielet trimestru, hydrochlorothiazide jista' jikkawża iskemija fetu-plaċentali u riskju ta' nuqqas ta' żvilupp tal-fetu.
English: Considering a paucity of trial data assessing titration steps with the combination the posology has been amended.
Maltese: Wara l-kunsiderazzjoni ta' nuqqas ta' dejta tal-provi li tivvaluta l-passi tat-titolazzjoni malkombinazzjoni, il-pożoloġija ġiet emendata.
English: TRITAZIDE has to be swallowed with liquid.
Maltese: TRITAZIDE jista' juri riżultat pożittiv.
English: Angioedema: very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; dermatitis psoriasiform, hyperhidrosis, rash, in particular maculo-papular, pruritus, alopecia
Maltese: Nekroliżi epidermali tossika, sindrome Stevens tessuti ta' taħtil-ġilda l-ostrużżjoni fil-pajp tan-nifs minħabba lanġjoedima jista' jkollu riżultat fatali; dermatite psorjasiforme, iperidrożi, raxx b'mod partikulari makulo-papulari, prurite, alopeċja
English: Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion.
Maltese: Peress li anġjotensin II jistimula l-ħruġ ta' aldosterone, ramiprilat jikkawża tnaqqis fis-sekrezzjoni ta' aldosterone.
English: Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis.
Maltese: Pazjenti f'riskju li jiżviluppaw l-iperkalimja jinkludi dawk b'insuffiċjenza renali, età (> 70 sena), dijabete mellitus li mhix ikkontrollata jew dawk li qed jieħdu salts tal-potassju, dijuretiċi li jżommu l-potassju u sustanzi attivi oħra li jżidu l-livell ta' potassju fil-plażma jew kundizzjonijiet bħal deidratazzjoni, dekompensazzjoni kardijaka akuta, aċidożi metabolika.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6 to 12 hours.
Maltese: B'hydrochlorothiazide, il-bidu tad-djuresi sseħħ wara sagħtejn, u l-massimu tal-effett iseħħ wara xi 4 sigħat waqt li l-azzjoni tibqa' għal kważi 6 sa 12-il siegħa.
English: Hydrochlorothiazide can reduce plasma volume as well as the uteroplacental blood flow.
Maltese: Hydrochlorothiazide jista' jnaqqas il-volum tal-plażma u l-fluss tad-demm uteroplaċentali.
English: Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3).
Maltese: Trattamenti barra mill-ġisem li wasslu għal kuntatt tad-demm ma' superfiċji b'ċarġ elletriku negattiv bħad-dijaliżi jew l-emofiltrazzjoni b'xi membrana ‘high-flux' (eż. membrana tal-polyacrylnitril) u afereżi tal-lipoproteina b'densità baxxa b'dextran sulphate minħabba ż-żieda fir-riskju ta' reazzjonijiet gravi li jixbħu dawk anafilattiċi (ara sezzjoni 4.3).
English: Czech Republic Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
Maltese: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
English: There were other contraindications in local SPC-s like acute hypertension or primary aldosteronism but they are not contraindications but rather non-indication in Europe.
Maltese: Kien hemm xi kontraindikazzjonijiet oħrajn f'SPC-s lokali bħall-ipertensjoni akuta jew aldosteroniżmu primarju iżda dawn mhumiex kontraindikazzjonijiet iżda non-indikazzjoni fl-Ewropa.
English: In case of angioedema TRITAZIDE must be discontinued.
Maltese: TRITAZIDE irid jinbela' ma' xi likwidu.
English: TRITAZIDE might affect the results of the test
Maltese: TRITAZIDE jista' jaffettwa ir-riżultati tat test.
English: Muscular weakness, musculoskeletal stiffness, tetany due to hydrochlorothiazide
Maltese: Debbulizza filmuskoli,ebusija muskoluskeltrali, tetanja minħabba hydrochlorothiazide
English: [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Maltese: [Isem u indirizz] {telefon} {fax}
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy.
Maltese: Mediċini antiinfjammatorji li mhumiex sterojdi u acetylsalicylic acid:
English: RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS
Maltese: Tnaqqis fil-libido, gajnikomastja (żvilupp eċċessiv tas-sider fir-raġel)
English: Curare-type muscle relaxants: Possible intensification and prolongation of the muscular relaxing effect.
Maltese: Rilassant muskolari tat-tip curare : possibbiltà li l-effett rilassanti fuq il-muskoli jiżdied u jittawwal.
English: Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration.
Maltese: Miżuri rakkomandati jinkludu detossifikazzjoni primarja (lavaġ gastriku, l-għoti ta' assorbenti) u miżuri biex jerġgħu jġibu lura l-istabbilità emodinamika li jinkludu l-għoti ta' agonisti adrenerġiċi alfa 1 jew lgħoti ta' anġjotensin II (anġjotensinamid).
English: Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.
Maltese: Barra minn hekk, kura fl-istess ħin ta' inibituri ACE u NSAIDs jista' jwassal għal żieda fir-riskju ta' aggravar fil-funzjoni renali u għal żieda f'kalimja.
English: Ireland: Tritazide tablets 2.5 mg/12.5 g
Maltese: Tritazide tablets 2.5 mg/12.5
English: • During the last 6 months of pregnancy (see section below on “Pregnancy and breast-feeding”)
Maltese: • Jekk qeda tredda' (ara s-sezzjoni hawn taħt "Tqala u treddigħ")
English: • Red swollen tongue or dry mouth
Maltese: • Tħossok sturdut.
English: Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia (see also sections 4.3 and 4.4).
Maltese: Trabi ta' ommijiet li ħadu l-inbituri ACE għandhom jiġu osservati mill-viċin għall-ipotensjoni oligurja u iperkalimja (ara wkoll sezzjonijiet 4.3 u 4.4).
English: Cough has been reported with the use of ACE inhibitors.
Maltese: Ġiet irrapportata s-sogħla bl-użu tal-inibituri ACE.
English: • This medicine has been prescribed for you.
Maltese: • Mediċini li jistgħu jbaxxu l-ammont ta' potassju fid-demm tiegħek.
English: Libido decreased, gynaecomastia
Maltese: Gheja, astinja
English: The patient should be closely monitored and the treatment should be symptomatic and supportive.
Maltese: Il-pazjent għandu jiġi segwit sew u l-kura għandha tkun sintomatika u ta' support.
English: POSSIBLE SIDE EFFECTS
Maltese: Possibbiltà ta' emoliżi
English: Germany:
Maltese: L-Irlanda:
English: The majority of the contraindications are related to use of ramipril as a component of the Tritazide.
Maltese: Il-maġġoranza tal-kontraindikazzjonijiet huma relatati mal-użu ta' ramipril bħala komponent tatTritazide.
English: The list of products which interact or may interact with Tritazide is acceptable.
Maltese: Il-lista ta' prodotti li jinteraġixxu jew li jistgħu jinteraġixxu ma' Tritazide hija aċċettabbli.
English: Elderly
Maltese: Iperkalimja
English: • Medicines which can increase the amount of potassium in your blood such as spironolactone,
Maltese: • Mediċini li jistgħu jżidu l-ammont ta' potassju fid-demm tiegħek bħal spironolactone,
English: These could be signs of lung problems including inflammation
Maltese: Dawn jistgħu jkunu sinjali ta' problemi tal-pulmun inkluż l-infjammazzjoni
English: Similar reductions were observed up to 104 weeks.
Maltese: Tnaqqis simili ġie osservat f'sa 104 ġimgħat.
English: System organ class
Maltese: Klassi tassistema talorgani
English: SE-151 85 Södertälje
Maltese: SE-151 85 Södertälje L-Isvezja
English: Fungal infection**
Maltese: Infezzjoni fungali**
English: AstraZeneca Pharma Poland Sp. z o.o.
Maltese: Polska AstraZeneca Pharma Poland Sp. z o.o.
English: AstraZeneca Czech Republic s.r.o.
Maltese: Česká republika AstraZeneca Czech Republic s.r.o.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 November, 2012
Maltese: 12 ta' Novembru 2012
English: Bristol-Myers Squibb Company Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy
Maltese: Bristol-Myers Squibb Company Contrada Fontana del Ceraso IT-03012 Anagni (FR) L-Italja
English: Parathyroid hormone (PTH)
Maltese: Ormon tal-paratirojde (PTH)
English: Elderly (≥ 65 years)
Maltese: Pazjenti anzjani (≥ 65 sena)
English: • The active substance is dapagliflozin.
Maltese: • Is-sustanza attiva hi dapagliflozin.
English: DPP-4 Inhibitor (sitagliptin2) ± Metformin1
Maltese: Inibitur DPP-4 (sitagliptin ± Metformin
English: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Maltese: AstraZeneca GmbH Tinsdaler Weg 183 22880
English: In in vitro studies, dapagliflozin neither inhibited cytochrome P450 (CYP) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, nor induced CYP1A2, CYP2B6 or CYP3A4.
Maltese: Fi studji in vitro, dapagliflozin la inibixxa cytochrome P450 (CYP) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, u l-anqas ikkawża l-induzzjoni ta' CYP1A2, CYP2B6 jew CYP3A4.
English: Uncommon**
Maltese: Mhux Komuni**
English: A meta-analysis of cardiovascular events in the clinical program was performed.
Maltese: Saret metaanaliżi tal-avvenimenti kardjovaskulari fil-programm kliniku.
English: A clinically relevant effect with other inducers (e.g. carbamazepine, phenytoin, phenobarbital) is not expected.
Maltese: Effett ta' rilevanza klinika b'indutturi oħrajn (eż carbamazepin, phenytoin, phenobarbital) mhux mistenni.
English: on one side and “1427” on the other side.
Maltese: fuq naħa u “1427” fuq in-naħa l-oħra.
English: Cardiac failure
Maltese: Insuffiċjenza kardijaka
English: Fifty-one percent (51%) of the subjects were men, 84% were White, 9% were Asian, 3% were Black and 4% were of other racial groups.
Maltese: Wieħed u ħamsin filmija (51%) tal-individwi kienu rġiel, 84% kienu Bojod, 9% kienu Ażjatiċi, 3% kienu Suwed u 4% kienu minn gruppi ta' razzez oħra.
English: Each tablet contains 25 mg of lactose anhydrous.
Maltese: Kull pillola fiha 25 mg ta' lactose anhydrous.
English: The tablets contain lactose anhydrous.
Maltese: Il-pilloli fihom lactose anhydrous.
English: hMean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides -2.7% versus -0.7%.
Maltese: Il-bidla medja perċentwali mil-linja bażi għal 10 mg dapagliflozin meta mqabbla ma' plaċebo, rispettivament, kienet: kolesterol totali 2.5% kontra 0.0%; kolesterol HDL 6.0% kontra 2.7%; kolesterol LDL 2.9% kontra -1.0%; trigliċeridi -2.7% kontra -0.7%.
English: Each tablet contains 50 mg of lactose anhydrous.
Maltese: Kull pillola fiha 50 mg ta' lactose anhydrous.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: 4.6 Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Maltese: Dapagliflozin huwa inibitur qawwi ħafna (Ki 0.55 nM), selettiv u riversibli tal-ko-trasportatur 2 (SGLT2) tal-glukows.
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/l (-0.87 to -0.33 mg/dl).
Maltese: Mal-24 ġimgħa, tnaqqis talkonċentrazzjonijiet ta' uric acid fis-serum kellhom medda ta' -48.3 sa' -18.3 micromoles/l (-0.87 sa' -0.33mg/dl).
English: Adverse reactions in placebo-controlled studiesa
Maltese: Reazzjonijiet avversi fl-istudji a kkontrollati bil-plaċebo
English: Dapagliflozin 10 mg + insulin ± oral glucose-lowering medicinal products2
Maltese: Dapagliflozin 10 mg + insulina ± prodotti mediċinali orali li jbaxxu l-glukows
English: Eighty percent (80%) of the subjects had a body mass index (BMI) ≥ 27.
Maltese: Tmenin fil-mija (80%) tal-individwi kellhom indiċi tal-massa talġisem (BMI) ≥ 27.
English: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyltransferase 1A9 (UGT1A9).
Maltese: Il-metaboliżmu ewlieni ta' dapagliflozin huwa permezz ta' konjugazzjoni tal-glucuronide medjat bilUDP glucuronosyltransferase 1A9 (UGT1A9).
English: Difference from placebo c
Maltese: Differenza minn plaċebo c
English: After administration of a 50 mg [14C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in feces.
Maltese: C]-dapagliflozin, 96% kien rekuperat, 75% fl-awrina u 21% fl-ippurgar.
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 tal-frekwenza huma skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa' < 1/10), mhux komuni (≥ 1/1000 sa' < 1/100), rari (≥ 1/10,000 sa' < 1/1000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Paediatric population Pharmacokinetics in the paediatric population have not been studied.
Maltese: Il-farmakokinetika fil-popolazzjoni pedjatrika ma ġietx studjata.
English: SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
Maltese: SGLT2 huwa t-trasportatur predominanti responsabbli għar-riassorbiment ta' glukows mill-filtrat talglomeruli lura fiċ-ċirkolazzjoni.
English: In feces,
Maltese: U LUŻU
English: (A satellite study was conducted to assess dapagliflozin exposures in milk and pups.)
Maltese: (Studju satellitari twettaq sabiex jiġu evalwati l-esponimenti għal dapagliflozin fil-ħalib u l-wild.)
English: Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Maltese: Reazzjonijiet avversi elenkati hawn taħt huma klassifikati skont il-frekwenza u l-klassi tas-sistema tal-organi (SOC).
English: INFORMATION IN BRAILLE forxiga 5 mg
Maltese: forxiga 5 mg
English: Dapagliflozin is approximately 91% protein bound.
Maltese: Madwar 91% ta' dapagliflozin jintrabat mal-proteini.
English: Cardiovascular safety
Maltese: Sigurtà kardjovaskulari
English: • if you are 75 years old or older, you should not start taking Forxiga.
Maltese: • jekk għandek 75 sena jew aktar m'għandekx tibda tieħu Forxiga.
English: Forxiga is not recommended for use in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.4, 4.8, 5.1 and 5.2).
Maltese: Forxiga mhux rakkomandat għall-użu f'pazjenti b'indeboliment renali moderat għal sever (pazjenti bi clearance tal-krejatinina [CrCl] < 60 ml/min jew rata stmata tal-filtrazzjoni mill-glomeruli [eGFR] < 60 ml/min/1.73 m2, ara sezzjonijiet 4.4, 4.8, 5.1 u 5.2).
English: Forxiga 5 mg tablets and Forxiga 10 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Il-pilloli Forxiga 5 mg u l-pilloli Forxiga 10 mg jiġu ġo folji tal-aluminju f'daqsijiet ta' pakketti ta' 14, 28 jew 98 pilloli miksijin b'rita ġo folji mhux imtaqqbin tal-kalendarju u 30x1 jew 90x1 pilloli miksijin b'rita ġo folji imtaqqbin b'doża individwali.
English: Nocturia** Renal impairment**,b
Maltese: Użu f'pazjenti b'indeboliment renali
English: Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/ml and 628 ng h/ml, respectively.
Maltese: Valuri tas-Cmax u l-AUCτ ta' dapagliflozin fl-istat fiss medju ġejometriku wara dożi ta' 10 mg darba kuljum ta' dapagliflozin kienu 158 ng/ml u 628 ng h/ml, rispettivament.
English: Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95% CI: 0.54, 1.10).
Maltese: 77 (95% CI: 0.54, 1.10).
English: fPolyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
Maltese: Poliurja tinkludi t-termini ppreferuti: pollakurja, poliurja, żieda fil-produzzjoni tal-awrina.
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablets 90x1 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30x1 pillola miksija b'rita 90x1 pillola miksija b'rita 98 pillola miksija b'rita
English: They have “5”
Maltese: Għandhom “5”
English: Following coadministration of dapagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes) a 22% decrease in dapagliflozin systemic exposure (AUC) was observed, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Maltese: Wara li dapagliflozin ngħata flimkien ma' rifampicin (induttur ta' varji trasportaturi attivi u metabolizzatur tal-mediċina), tnaqqis ta' 22% fl-esponiment sistemiku ta' dapagliflozin (AUC) deher, iżda ma kienx hemm sinifikat kliniku fuq l-eskrezzjoni ta' glukows fuq 24-siegħa.
English: Na
Maltese: JIS
English: Forxiga contains the active substance dapagliflozin.
Maltese: Forxiga fih is-sustanza attiva li tissejjaħ dapagliflozin.
English: EU/1/12/795/004 30 x 1 (unit dose) film-coated tablets EU/1/12/795/005 90 x 1 (unit dose) film-coated tablets
Maltese: EU/1/12/795/001 14-il pillola miksija b'rita EU/1/12/795/002 28 pillola miksija b'rita EU/1/12/795/003 98 pillola miksija b'rita EU/1/12/795/004 30 x 1 (doża waħda) pillola miksija b'rita EU/1/12/795/005 90 x 1 (doża waħda) pillola miksija b'rita
English: EU/1/12/795/009 30 x 1 (unit dose) film-coated tablets EU/1/12/795/010 90 x 1 (unit dose) film-coated tablets
Maltese: EU/1/12/795/006 14-il pillola miksija b'rita EU/1/12/795/007 28 pillola miksija b'rita EU/1/12/795/008 98 pillola miksija b'rita EU/1/12/795/009 30 x 1 (doża waħda) pillola miksija b'rita EU/1/12/795/010 90 x 1 (doża waħda) pillola miksija b'rita
English: Vulvovaginitis, balanitis and related genital infections Vulvovaginitis, balanitis and related genital infections were reported in 5.5% and 0.6% of subjects who received dapagliflozin 10 mg and placebo, respectively.
Maltese: Vulvovaġinite, balanite u infezzjonijiet ġenitali relatati Vulvovaġinite, balanite u infezzjonijiet ġenitali relatati kienu rrappurtati f'5.5% u 0.6% tal-individwi li rċievew dapagliflozin 10 mg u plaċebo, rispettivament.
English: The frequency of minor episodes of hypoglycaemia was similar between treatment groups, including placebo, with the exceptions of studies with add-on sulphonylurea (SU) and add-on insulin therapies.
Maltese: Il-frekwenza ta' episodji minuri ta' ipogliċemija kienet simili bejn il-gruppi ta' kura, inkluż plaċebo, bl-eċċezzjonijiet ta' studju fejn ġie miżjud ma' terapiji b'sulphonylurea (SU) u bl-insulina.