FrancophonIA/ELRC3.0 huggingface dataset:
English: Restriction of tyrosine and phenylalanine in the diet should limit toxicity associated with this type of tyrosinemia.
Maltese: tyrosine u phenylalanine fid-dieta għandha tillimita t-tossiċità marbuta ma' dan it-tip ta' tirosinemija.
English: However, in addition to the tests above, during the initiation of therapy, switch from twice daily to once daily dosing or if there is a deterioration, it may be necessary to follow more closely all available biochemical parameters (i.e. plasma succinylacetone, urine 5-aminolevulinate (ALA) and erythrocyte porphobilinogen (PBG)-synthase activity).
Maltese: Madankollu, flimkien mat-testijiet t'hawn fuq, matul il-bidu tat-terapija, aqleb minn dożaġġ ta' darbtejn kuljum għal darba kuljum jew jekk ikun hemm deterjorament, jista' jkun meħtieġ li ssegwi iktar mill-qrib il-parametri bijokimiċi kollha disponibbli (jiġifieri succinylacetone fil-plażma, 5-aminolevulinate (ALA) fl-awrina u l-attività ta' erythrocyte porphobilinogen (PBG)-synthase).
English: ≤ 2 months ≤ 6 months > 6 months Overall
Maltese: Età fil-bidu tal-kura Sentejn 4 snin 6 snin ≤ xahrejn ≤ 6 xhur > 6 xhur
English: NAME OF THE MEDICINAL PRODUCT Nityr 10 mg tablets
Maltese: Pilloli ta' Nityr 10 mg
English: In an international survey of patients with HT-1 on treatment with dietary restriction alone, it was found that HCC had been diagnosed in 18% of all patients aged 2 years and above.
Maltese: Fi stħarriġ internazzjonali ta' pazjenti b'HT 1 fuq kura ta' restrizzjoni tad-dieta waħedha, instab li HCC kienet ġiet iddijanjostikata fi 18% tal-pazjenti kollha li kellhom sentejn u aktar.
English: Do not breast-feed while taking this medicine, see section “Do not take Nityr”.
Maltese: Treddax waqt li tkun qed tieħu din il-mediċina, ara s- sezzjoni “Tiħux Nityr”.
English: Common eye related side effects (may affect more than 1 in 10 people) are inflammation in the eye (conjunctivitis), opacity and inflammation in the cornea (keratitis), sensitivity to light (photophobia) and eye pain.
Maltese: Effetti sekondarji komuni relatati mal-għajnejn (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) kkawżati minn livelli ta' tyrosine ogħla huma infjammazzjoni fl-għajn (konġuntivite), opaċità u infjammazzjoni fil-kornea (keratite), sensittività għad-dawl (fotofobija) u uġigħ fl-għajnejn.
English: Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarised in the table below.
Maltese: Probabbiltajiet tas-sopravivenza wara sentejn, 4 u 6 snin ta' kura b'nitisinone huma miġbura fil-qosor fit-tabella hawn taħt.
English: - The other ingredients are glycerol dibehenate, and lactose monohydrate (see section 2 under
Maltese: - L_ingredjenti l-oħra huma l-glycerol dibehenate, u l-lattożju monoidrat (ara taqsima 2 taħt ‘Nityr fih il-lattożju').
English: Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Maltese: Kura ta' pazjenti adulti u pedjatriċi (f'kull medda ta' età) b'dijanjożi kkonfermata ta' tirosinemija ereditarja ta' tip 1 (HT-1) flimkien ma' restrizzjoni tad-dieta ta' tyrosine u phenylalanine.
English: This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children.
Maltese: Din il-mediċina tintuża għall-kura ta' marda rari msejħa tirosinemija ereditarja tip 1 fl- adulti, adolexxenti u fit-tfal.
English: Nitisinone has shown embryo-foetal toxicity in the mouse and rabbit at clinically relevant dose levels.
Maltese: Nitisinone wera tossiċità embriju-fetali fil-ġrieden u fil-fniek f'livelli tad-doża li kienu klinikament rilevanti.
English: The tablets are white to beige, round, flat which may display light yellow to brown speckles marked with “L” on one side and “10” on the other side.
Maltese: Il-pilloli ċatti huma bojod fil-beġ, tondi, u jista' jkollhom tikek sofor ċari u kannella mmarkati b'“L” fuq naħa u “10” fuq in-naħa l-oħra.
English: What Nityr contains - The active substance is nitisinone.
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Nityr - Is-sustanza attiva hi nitisinone.
English: Eye problems could be a sign of inadequate dietary control (see section 4).
Maltese: jistgħu jkunu sinjal ta' kontroll inadegwat tad-dieta.
English: Patients who have problems swallowing Nityr tablets whole, are recommended to take alternative nitisinone formulations.
Maltese: Il-pazjenti li għandhom problem biex jibilgħu l-pilloli ta' Nityr huma rakkomandati jieħdu formulazzjonijiet alternattivi ta' nitisinone.
English: < 2 months > 2-6 months > 6 months
Maltese: Età fil-bidu tas-sintomi Sena Sentejn < xahrejn > 2-6 xhur > 6 xhur
English: The adverse reactions listed below by MedDRA system organ class and absolute frequency, are based on data from a clinical trial and post-marketing use.
Maltese: Ir-reazzjonijiet avversi elenkati hawn taħt skont is-sistema tal-klassifika tal-organi MedDRA u skont il-frekwenza assoluta, huma bbażati fuq dejta minn prova klinika u wara l-użu għat-tqegħid fis-suq.
English: Pregnancy
Maltese: Lattożju
English: Package leaflet: Information for the user Nityr 10 mg tablets nitisinone
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC:
English: In this disease your body is unable to completely break down the amino acid tyrosine (amino acids are building blocks of our proteins), forming harmful substances.
Maltese: F'din il-marda, ġismek ma jkunx kapaċi jkisser kompletament l-amino acid tyrosine (amino acids huma blokok tal-bini tal-proteini tagħna), b'hekk jifforma sustanzi ta' ħsara.
English: Adverse reactions affecting the MedDRA system organ class ‘Blood and lymphatic system disorders' subsided during continued nitisinone treatment.
Maltese: Ir-reazzjonijiet avversi li jaffettwaw id-‘Disturbi tad-demm u tas-sistema limfatika' tassistema tal-klassifika tal-organi MedDRA naqsu matul kura kontinwata b'nitisinone.
English: HDPE 75 mL square bottles with a tamper-evident child-resistant closure of polypropylene (PP).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-fliexken kwadri ta' HDPE 75 mL jiġu b'siġill ta' polipropilene (PP) li jimmarka jekk il-flixkun infetaħx diġà u huwa reżistenti għall-ftuħ mit-tfal.
English: 17 July 2018 EMA/498908/2018
Maltese: 17 ta' Lulju 2018 EMA/498908/2018
English: The review of HES solutions for infusion was initiated on 17 October 2017 at the request of the Swedish Medical Products Agency, under Article 107i of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' soluzzjonijiet ta' HES inbdiet fis-17 ta' Ottubru 2017 fuq talba tal-Aġenzija Żvediża għall-Prodotti Mediċi, skont l-Artikolu 107i tad-Direttiva 2001/83/KE.
English: • HES solutions for infusion are also contraindicated in dehydrated patients, hyperhydrated patients, patients with intracranial or cerebral haemorrhage, burn injuries, severe hyperkalaemia, hypernatraemia, hyperchloraemia, congestive heart failure, organ transplant patients and patients with impaired hepatic function.
Maltese: • Soluzzjonijiet għall-infużjoni ta' HES huma kontraindikati wkoll f'pazjenti deidratati, pazjenti iperidratati, pazjenti b'emorraġija intrakranjali jew ċerebrali, korrimenti ta' ħruq, iperkalimja severa, ipernatremija, iperkloremija, insuffiċjenza konġestiva tal-qalb, pazjenti bi trapjant ta' organu u pazjenti b'funzjoni tal-fwied indebolita.
English: • Alternative therapeutic options are available for routine clinical practice and should be considered according to relevant clinical guidelines.
Maltese: • Hemm disponibbli għażliet terapewtiċi alternattivi għal prassi klinika ta' rutina u għandhom jiġu kkunsidrati skont linji gwida kliniċi rilevanti.
English: Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
Maltese: Soluzzjonijiet ta' hydroxyethyl starch:
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta lill-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards ta' sigurtà armonizzati għall-mediċini awtorizzati permezz ta' proċeduri nazzjonali fl-UE kollha.
English: • Additional studies are ongoing with HES solutions in patients with trauma and those undergoing elective surgery to further investigate the long-term safety of HES prescribed according to the recommendations for use (dose less than 30 ml/kg and duration less than 24 hours).
Maltese: • Għadhom għaddejjin studji addizzjonali b'soluzzjonijiet ta' HES f'pazjenti bi trawma u f'dawk li ssirilhom kirurġija elettiva sabiex tiġi investigata aktar is-sigurtà fit-tul ta' HES preskritt skont irrakkomandazzjonijiet għall-użu (doża inqas minn 30 ml/kg u durata inqas minn 24 siegħa).
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Maltese: Ġiet irrappurtata ħtieġa miżjuda għal terapija ta' sostituzzjoni talkliewi sa 90 jum wara l-għoti ta' HES.
English: Besides blood products, there are two types of medicines used for plasma volume replacement: crystalloids and colloids.
Maltese: Minbarra prodotti tad-demm, hemm żewġ tipi ta' mediċini li jintużaw għas-sostituzzjoni tal-volum tal-plażma: kristallojdi u kollojdi.
English: On 27 June 2018, the CMDh1 decided that hydroxyethyl starch (HES) solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented.
Maltese: Fis-27 ta' Ġunju 2018, is-CMDh1 iddeċieda li soluzzjonijiet għall-infużjoni ta' hydroxyethyl starch (HES) għandhom jibqgħu fis-suq diment li tiġi implimentata kombinazzjoni ta' miżuri addizzjonali għallprotezzjoni tal-pazjenti.
English: After looking at these specific aspects, in May 2018 the PRAC confirmed its previous recommendation for suspension and sent a revised recommendation to the CMDh.
Maltese: Wara li ħares lejn dawn l-aspetti speċifiċi, f'Mejju 2018, il-PRAC ikkonferma r-rakkomandazzjoni preċedenti tiegħu għal sospensjoni u bagħat rakkomandazzjoni reveduta lis-CMDh.
English: Colloids contain large molecules such as starch, whereas crystalloids, such as saline or Ringer's solutions, are electrolyte solutions.
Maltese: Il-kollojdi fihom molekuli kbar bħal lamtu, filwaqt li l-kristallojdi, bħal salina jew soluzzjonijiet ta' Ringer, huma soluzzjonijiet ta' elettroliti.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations on 12 January 2018.
Maltese: Ir-reviżjoni l-ewwel saret mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), ilKumitat tal-EMA responsabbli għall-evalwazzjoni ta' kwistjonijiet tas-sigurtà għall-mediċini tal-bniedem, li għamel sett ta' rakkomandazzjonijiet fit-12 ta' Jannar 2018.
English: • Use of HES solutions for infusion should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 hours.
Maltese: • L-użu ta' soluzzjonijiet għall-infużjoni ta' HES għandu jiġi ristrett għall-fażi inizjali ta' risuxxitazzjoni tal-volum b'intervall ta' ħin massimu ta' 24 siegħa.
English: HES solutions for infusion are used to replace plasma volume following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids' alone is not considered sufficient.
Maltese: Soluzzjonijiet għall-infużjoni ta' HES jintużaw biex jissostitwixxu l-volum tal-plażma wara telf tad-demm akut (f'daqqa), meta kura bi prodotti alternattivi magħrufa bħala “kristallojdi” biss ma titqiesx biżżejjed.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position on 24 January 2018.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura DeċentralizzataBniedem (CMDh), li adotta pożizzjoni fl-24 ta' Jannar 2018.
English: The CMDh agreed with the PRAC's assessment of the serious risks in critically ill patients and patients with sepsis.
Maltese: Is-CMDh qabel mal-valutazzjoni tal-PRAC tar-riskji serji f'pazjenti morda serjament u f'pazjenti b'sepsis.
English: In April 2018, the European Commission requested that the PRAC and the CMDh further consider any possible unmet medical need that could result from a suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.
Maltese: F'April 2018, il-Kummissjoni Ewropea talbet lill-PRAC u lis-CMDh biex jikkunsidraw aktar kwalunkwe ħtieġa medika possibbli li ma ġietx issodisfata li tista' tirriżulta minn sospensjoni, kif ukoll il-fattibbiltà u l-effettività probabbli ta' miżuri tal-imminimizzar tar-riskju addizzjonali.
English: In January 2018, EMA's safety committee PRAC recommended suspending the marketing authorisations of these medicines because they continued to be used in critically ill patients and patients with sepsis despite restrictions introduced in 2013 due to the risk of kidney injury and death in these patients.
Maltese: F'Jannar 2018, il-kumitat tas-sigurtà tal-EMA, il-PRAC, irrakkomanda li jiġu sospiżi l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' dawn il-mediċini peress li baqgħu jintużaw f'pazjenti morda serjament u f'pazjenti b'sepsis minkejja restrizzjonijiet li ġew introdotti fl-2013 minħabba r-riskju ta' ħsara fil-kliewi u mewt f'dawn il-pazjenti.
English: In June 2018, the CMDh concluded that HES solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented.
Maltese: F'Ġunju 2018, isCMDh ikkonkluda li soluzzjonijiet għall-infużjoni ta' HES għandhom jibqgħu fis-suq diment li tiġi implimentata kombinazzjoni ta' miżuri addizzjonali għall-protezzjoni tal-pazjenti.
English: • the implementation of a controlled access programme by the companies holding the marketing authorisations to ensure that only accredited hospitals will be supplied with these medicines.
Maltese: • l-implimentazzjoni ta' programm ta' aċċess ikkontrollat mill-kumpaniji li għandhom lawtorizzazzjonijiet għat-tqegħid fis-suq sabiex jiġi żgurat li sptarijiet akkreditati biss jiġu fornuti b'dawn il-mediċini.
English: However, the CMDh gave further consideration to the place of HES in the clinical practice of some countries, noted that previous risk minimisation measures had some effect, and considered that a combination of new risk minimisation measures would effectively ensure that HES solutions are not used in patients at risk.
Maltese: Madankollu, is-CMDh qies aktar il-lok ta' HES fil-prassi klinika ta' xi pajjiżi, innota li miżuri talimminimizzar tar-riskju preċedenti kellhom ftit effett, u kkunsidra li kombinazzjoni ta' miżuri talimminimizzar tar-riskju ġodda effettivament tiżgura li soluzzjonijiet ta' HES ma jintużawx f'pazjenti f'riskju.
English: • HES solutions for infusion are contraindicated in patients with renal impairment or undergoing renal replacement therapy.
Maltese: • Soluzzjonijiet għall-infużjoni ta' HES huma kontraindikati f'pazjenti b'indeboliment tal-kliewi jew li għaddejjin minn terapija ta' sostituzzjoni tal-kliewi.
English: • HES solutions for infusion are contraindicated in severe coagulopathy.
Maltese: • Soluzzjonijiet għall-infużjoni ta' HES huma kontraindikati f'koagulopatija severa. Soluzzjonijiet ta' HES għandhom jitwaqqfu mal-ewwel sinjal ta' koagulopatija.
English: As the CMDh position was adopted by majority vote, the CMDh position was sent back to the European Commission, which took an EU-wide legally binding decision on 17 July 2018.
Maltese: Il-pożizzjoni tas-CMDh ġiet adottata b'vot tal-maġġoranza u l-kwistjoni ntbagħtet lill-Kummissjoni Ewropea, li ħadet deċiżjoni legalment vinkolanti fl-UE kollha fis-17 ta' Lulju 2018.
English: They belong to the class of medicines known as colloids.
Maltese: Dawn jappartjenu għall-klassi ta' mediċini magħrufa bħala kollojdi.
English: • HES solutions for infusion are used to replace fluids in the body after acute (sudden) blood loss.
Maltese: • Soluzzjonijiet għall-infużjoni ta' HES jintużaw biex jissostitwixxu fluwidi fil-ġisem wara telf taddemm akut (f'daqqa).
English: This followed further reflection, in consultation with EU Member States, on whether it would be feasible to introduce new measures that would effectively reduce the risks with these medicines.
Maltese: Dan ġie segwit minn riflessjoni ulterjuri, f'konsultazzjoni mal-Istati Membri talUE, dwar jekk huwiex fattibbli li jiġu introdotti miżuri ġodda li effettivament inaqqsu r-riskji b'dawn ilmediċini.
English: • Because of the risk of kidney injury and mortality, HES solutions for infusion are contraindicated in patients with sepsis or in critically ill patients.
Maltese: • Minħabba r-riskju ta' ħsara fil-kliewi u l-mortalità, soluzzjonijiet għall-infużjoni ta' HES huma kontraindikati f'pazjenti b'sepsis jew f'pazjenti morda serjament.
English: The CMDh also requested marketing authorisation holders to conduct studies to check that only patients who should be treated with these medicines are receiving them.
Maltese: Is-CMDh talab ukoll lid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq biex iwettqu studji sabiex jivverifikaw li pazjenti li għandhom jiġu kkurati b'dawn il-mediċini biss ikunu qed jirċivuhom.
English: • warnings in the medicines' packaging and at the top of the summaries of product characteristics (SmPCs) reminding healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in critically ill patients;
Maltese: • twissijiet fl-imballaġġ tal-mediċini u fin-naħa ta' fuq tas-sommarji tal-karatteristiċi tal-prodott (SmPCs) li jfakkru lill-professjonisti tal-kura tas-saħħa li dawn il-mediċini m'għandhomx jintużaw f'pazjenti b'sepis jew b'indeboliment tal-kliewi jew f'pazjenti morda serjament;
English: HES solutions for infusion are used for the management of hypovolaemia (low blood volume) caused by acute blood loss, where treatment with alternative infusion solutions known as ‘crystalloids' alone is not considered sufficient.
Maltese: Soluzzjonijiet għall-infużjoni ta' HES jintużaw għall-immaniġġjar ta' ipovolemija (volum baxx taddemm) ikkawżat minn telf tad-demm akut, meta kura b'soluzzjonijiet għall-infużjoni alternattivi magħrufa bħala “kristallojdi” biss ma titqiesx biżżejjed.
English: EU/1/03/264/001 Zevalin
Maltese: EU/1/03/264/001
English: Packaging Content (concentration)
Maltese: Kontenut (konċentrazzjoni)
English: 1 kit containing: 1 vial of ibritumomab tiuxetan, 1 vial of sodium acetate solution, 1 vial of formulation buffer and 1 empty reaction vial
Maltese: 1 kunjett ta' soluzzjoni ta' sodium acetate, 1 kunjett ta' baffer tal-formulazzjoni u 1 kunjett vojt għar-reazzjoni
English: 1.6 mg/ml Kit for radiopharmaceutica l preparation for infusion
Maltese: 1.6 mg/ml
English: Intravenous use Vial (glass)
Maltese: Kunjett (ħġieġ)
English: • Signs/symptoms of DKA.
Maltese: • Sinjali/sintomi ta' DKA.
English: Date of first authorisation: 12 November 2012 Date of latest renewal: 28 August 2017
Maltese: 12 ta' Novembru 2012 Data tal-aħħar tiġdid: 28 ta' Awwissu 2017
English: • Insulin therapy should be continuously optimised.
Maltese: • It-terapija bl-insulina għandha tiġi ottimizzata kontinwament.
English: Placebo + Insulin
Maltese: Placebo + Insulina
English: Impending DKA > 1.5-3.0 mmol/L Moderate
Maltese: > 1.5-3.0 mmol/L Moderat
English: Do not take Forxiga:
Maltese: Tieħux Forxiga:
English: Forxiga should not be initiated in patients with a glomerular filtration rate [GFR] < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min (see sections 4.4, 4.8, 5.1 and 5.2).
Maltese: [GFR] < 60 mL/min u għandu jitwaqqaf f'GFR li b'mod persistenti tkun inqas minn 45 mL/min (ara sezzjonijiet 4.4, 4.8, 5.1 u 5.2).
English: • Patients with euglycaemic DKA should receive glucose, insulin and fluids for DKA,
Maltese: • Pazjenti b'DKA ewgliċemika għandhom jirċievu glucose, insulina u fluwidi għal DKA,
English: Pharmacotherapeutic group: Drugs used in diabetes, Sodium-glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK01
Maltese: Mediċini li jintużaw fid-dijabete, inibituri ta' ko-trasportatur 2 ta' sodium-glucose (SGLT2, Sodium-glucose co-transporter 2), Kodiċi ATC:
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), and 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), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Probable DKA > 3.0 mmol/L
Maltese: > 3.0 mmol/L
English: Metformin or metformin hydrochloride were part of the usual care in 69.4% and 64.0% of the patients for the dapagliflozin and placebo groups, respectively.
Maltese: Metformin jew metformin hydrochloride kienu parti mill-kura tas-soltu f'69.4 % u 64.0 % tal-pazjenti għallgruppi ta' dapagliflozin u plaċebo groups, rispettivament.
English: • For renal function with GFR < 60 mL/min, at least 2 to 4 times per year.
Maltese: • Għal funzjoni renali b'GFR < 60 mL/min, għallinqas
English: • Dapagliflozin is not a substitute for insulin (and does not alter insulin-sensitivity).
Maltese: • Dapagliflozin mhuwiex sostitut għall-insulina (u ma jibdilx is-sensittività għall-insulina).
English: In addition, dapagliflozin reduced the new onset of sustained albuminuria (hazard ratio 0.79 [95% CI 0.72, 0.87]) and led to greater regression of macroalbuminuria (hazard ratio 1.82 [95% CI 1.51, 2.20]) compared with placebo.
Maltese: • Barra minn hekk, dapagliflozin naqqas il-bidu ġdid ta' albuminurja sostnuta (proporzjon ta' periklu 0.79 [95% CI 0.72, 0.87]) u wassal għal rigressjoni akbar ta' makroalbuminurja (proporzjon ta' periklu 1.82 [95% CI 1.51, 2.20]) meta mqabbel ma' plaċebo.
English: Mean 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% kontra1.0%; trigliċeridi -2.7% kontra -0.7%. ara sezzjoni 4.4
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 tassistema tal-organi (SOC).
English: They have “5” on one side and “1427” on the other side.
Maltese: Għandhom “5” fuq naħa u “1427” fuq in-naħa l-oħra.
English: Table 1 Clinical stage Blood Ketone (betahydroxybutyrate)
Maltese: Ketone fid-Demm (betahydroxybutyrate)
English: Forxiga is used in adult patients (aged 18 years and older).
Maltese: Forxiga jintuża f'pazjenti adulti (li għandhom 18-il sena u aktar).
English: Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19% increase in AUC of simvastatin and 31% increase in AUC of simvastatin acid.
Maltese: Taħlita ta' doża waħda ta' dapagliflozin 20 mg u simvastatin (sottostrat ta' CYP3A4) wasslet għal żieda ta' 19 % fl-AUC ta' simvastatin u 31% żieda fl-AUC ta; aċidu ta' simvastatin.
English: 0.6-1.5 mmol/L Trace or Small
Maltese: Ketonemija 0.6-1.5 mmol/L
English: Vulvovaginal pruritus Pruritus genital
Maltese: Prurite vulvovaġin ali