FrancophonIA/ELRC3.0 huggingface dataset:
English: Dapagliflozin was rapidly and well absorbed after oral administration.
Maltese: Dapagliflozin kien assorbit malajr u tajjeb wara l-amministrazzjoni orali.
English: Evidence of sustained glucose excretion was seen in subjects with type 2 diabetes mellitus given dapagliflozin 10 mg/day for up to 2 years.
Maltese: Dehret evidenza ta' tneħħija sostnuta ta' glukożju f'individwi bid-dijabete (diabetes mellitus) tat-tip 2 li ngħataw 10 mg dapagliflozin kuljum sa żmien sentejn.
English: Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Xigduo 5 mg/1,000 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
English: • if you are allergic to dapagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal dapagliflozin, metformin jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: Post-prandial glucose
Maltese: Glukożju fl-awrina
English: The primary endpoints were time to first event of the composite of cardiovascular death, myocardial infarction or ischaemic stroke (MACE) and time to first event of the composite of hospitalisation for heart failure or cardiovascular death.
Maltese: Composite of cardiocvascular death/myocardial infarction/ischaemic stroke
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Maltese: Sintomi gastrointestinali bħal dardir, rimettar, dijarea, uġigħ addominali u nuqqas ta' aptit iseħħu l-iktar frekwenti matul il-bidu tat-terapija u fil-biċċa l-kbira tal-każi jitfejqu spontanjament.
English: In the dapagliflozin cardiovascular outcomes study, no increased risk of major hypoglycaemia was observed with dapagliflozin therapy compared with placebo.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin, ma ġie osservat l-ebda riskju miżjud ta' ipogliċemija maġġuri b'terapija b'dapagliflozin meta mqabbel mal-plaċebo.
English: Dapagliflozin plus metformin
Maltese: Dapagliflozin Better
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-Linja Bażi Differenza minn Plaċebo c
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss tal-valuri tal-glucose fid-demm, taħt 14 mmol/L (250 mg/dL).
English: The SGLT2 is selectively expressed in the kidney with no expression detected in more than 70 other tissues including liver, skeletal muscle, adipose tissue, breast, bladder and brain.
Maltese: L-SGLT2 huwa espress b'mod selettiv fil-kliewi, mingħajr ebda espressjoni perċepita f'iktar minn 70 tessut ieħor, inklużi l-fwied, il-muskoli skeletali, it-tessut xaħmi, is-sider, il-bużżieqa tal-awrina u l-moħħ.
English: Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis.
Maltese: Kun af li tista' tidher infezzjoni uroġenitali jew li jista' jidher axxess perineali qabel faxxite nekrotizzanti.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Maltese: Pazjenti li jistgħu jkunu f'riskju ogħla ta' DKA jinkludu pazjenti b'riżerva ta' funzjoni baxxa ta' beta-ċelluli (eż. pazjenti bid-dijabete tat-tip 2 b' Cpeptide baxx jew dijabete awtoimmuni moħbija fl-adulti (LADA) jew pazjenti bi storja ta' pankreatite), pazjenti b'kundizzjonijiet li jwasslu għal teħid restritt tal-ikel jew deidrazzjoni severa, pazjenti li għalihom jitnaqqsu d-dożi tal-insulina u pazjenti b'rekwiżiti miżjuda tal-insulina minħabba mard mediku akut, kirurġija jew abbuż tal-alkoħol.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Maltese: Indipendentament mill-azzjoni tiegħu fuq il-gliċemija, metformin għandu effetti favorevoli fuq ilmetaboliżmu tal-lipidi fil-bnedmin.
English: • For renal function with GFR levels < 60 mL/min and in elderly patients, at least 2 to 4 times per year.
Maltese: • Għal funzjoni renali b'livelli tal-GFR li jqarrbu 60 mL/min u f'pazjenti anzjani, tal-anqas darbtejn sa erba' darbiet fis-sena.
English: Liver function disorders Hepatitis
Maltese: Disturbi filfunzjoni talfwied Epatite
English: • if you have “type 1 diabetes” - the type that usually starts when you are young, and your body does not produce any insulin.
Maltese: • jekk għandek “dijabete tat-tip 1” - it-tip ta' dijabete li normalment tibda meta tkun żgħir, u ġismek ma jipproduċi l-ebda insulina.
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: Ir-riskju ta' ketoaċidożi dijabetika għandu jitqies f'każ ta' sintomi mhux speċifiċi bħal dardir, rimettar, anorexja, uġigħ addominali, għatx eċċessiv, diffikultà biex tieħu nifs, konfużjoni, għeja mhux tas-soltu jew irqad.
English: • if you have a severe infection.
Maltese: • jekk għandek infezzjoni severa.
English: Lactic acidosis Vitamin B12 deficiency h,§
Maltese: B12 (eż. anemija megaloblastika).
English: In a separate analysis of subjects on insulin plus metformin, similar reductions in HbA1c to those seen in the total study population were seen in subjects treated with dapagliflozin with insulin plus metformin.
Maltese: F'analiżi separata ta' individwi fuq l-insulina flimkien ma' metformin, deher tnaqqis simili fl-HbA1c għal dak li deher fil-popolazzjoni totali tal-istudju f'pazjenti ttrattati b'dapagliflozin mal-insulina flimkien ma' metformin.
English: At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products, including metformin), the HbA1c reductions were -0.71% and -0.06% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
Maltese: Fil-ġimgħa 104 għall-insulina (bi prodotti mediċinali orali addizzjonali li jbaxxu l-glukożju jew mingħajrhom, inkluż metformin), it-tnaqqis fl-HbA1c kien ta' bidla medja aġġustata ta' -0.
English: Glycaemic control
Maltese: Ischaemic stroke
English: In a juvenile toxicity study, when dapagliflozin was dosed directly to young rats from postnatal day 21 until postnatal day 90, renal pelvic and tubular dilatations were reported at all dose levels; pup exposures at the lowest dose tested were ≥ 15 times the maximum recommended human dose.
Maltese: Fi studju dwar l-effett tossiku il-frieħ; , meta dapagliflozin kien mogħti direttament lil firien żgħar minn 21 jum wara t-twelid sa 90 jum wara t-twelid, kienu rrappurtati dilatazzjonijiet fil-pelvi u fit-tubuli renali fillivelli kollha tad-dożi; l-esponimenti fil-frieħ bl-inqas doża ttestjata kienu ≥ 15-il darba tal-massimu rrakkomandat għal dożi umani.
English: • nausea, vomiting
Maltese: • nawsja, rimettar
English: Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and
Maltese: Dan il-prodott mediċinali ma għandux jintuża f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: The following adverse reactions have been identified in the placebo-controlled dapagliflozin plus metformin clinical studies, dapagliflozin clinical studies and metformin clinical studies and post-marketing experience.
Maltese: L-effett ta' dan il-prodott mediċinali jew dapagliflozin fuq il-fertilità fil-bnedmin ma ġiex studjat.
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Maltese: Minn dan il-grupp tal-aħħar, 80 % kienu fuq metformin waħdu, 12 % kienu fuq terapija ta' metformin flimkien ma' sulphonylurea, u l-bqija kienu fuq prodotti mediċinali orali oħrajn li jbaxxu l-glukożju.
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with dapagliflozin (see sections 4.2 and 4.8).
Maltese: Għaldaqstant, doża inqas ta' insulina jew ta' segretagogu tal-insulina tista' tkun meħtieġa biex jitnaqqas ir-riskju tal-ipogliċemija meta użati flimkien ma' dapagliflozin (ara sezzjonijiet 4.2 u 4.8).
English: To treat diabetes:
Maltese: Kategorija farmakoterapewtika:
English: Dapagliflozin and related metabolites are primarily eliminated via urinary excretion with less than 2% as unchanged dapagliflozin.
Maltese: Dapagliflozin u metaboliti relatati jiġu eliminati primarjament permezz tat-tneħħija fl-awrina b'inqas minn 2% bħala dapagliflozin mhux mibdul.
English: Like for all diabetic patients it is important to counsel patients on routine preventative foot care.
Maltese: Bħal fil-każ tal-pazjenti dijabetiċi kollha, huwa importanti li l-pazjenti jiġu rrakkomandati fuq kura tas-saqajn preventiva ta' rutina.
English: Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of treatment should be considered when treating pyelonephritis or urosepsis.
Maltese: Infezzjonijiet fil-passaġġ urinarju jistgħu jkunu assoċjati ma' żieda fir-riskju ta' infezzjoni fil-passaġġ urinarju; għaldaqstant, għandu jiġi kkunsidrat it-twaqqif temporanju tal-kura waqt il-kura tal-pjelonefrite jew urosepsis.
English: Change from baseline Difference from glipizide + metformin c
Maltese: Differenza minn glipizide + metformin (95% CI)
English: Paediatric population Interaction studies have only been performed in adults.
Maltese: Popolazzjoni pedjatrika Studji dwar l-interazzjoni saru biss fuq adulti.
English: Direct administration of dapagliflozin to weanling juvenile rats and indirect exposure during late pregnancy (time periods corresponding to the second and third trimesters of pregnancy with respect to human renal maturation) and lactation are each associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny.
Maltese: L-amministrazzjoni diretta ta' dapagliflozin lil firien żgħar miftumin u l-esponiment indirett lejn l-aħħar tat-tqala (il-perjodi taż-żmien jikkorrispondu mat-tieni u t-tielet trimestru tat-tqala fir-rigward talmaturazzjoni tal-kliewi umani) u matul it-treddigħ huma kollha assoċjati ma' inċidenza ogħla u/jew ma' severità ta' dilatazzjoni tal-pelvi u tat-tubuli renali fil-frieħ.
English: In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in seated systolic blood pressure at Week 24: -4.8 mmHg compared to -1.7 mmHg for placebo (p < 0.05).
Maltese: Fi studju dedikat f'pazjenti dijabetiċi b'eGFR ≥ 45 sa < 60 mL/min/1.73 m2, kura bi dapagliflozin uriet tnaqqis fil-pressjoni tad-demm sistolika meta l-pazjent ikun bilqiegħda f'Ġimgħa 24: -4.8 mmHg meta mqabbel ma' -1.7 mmHg għall-plaċebo (p < 0.05).
English: These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval.
Maltese: Dawn l-individwi kellhom il-glukożju perċepibbli flawrina għal perjodu ta' żmien relatat mad-doża (mill-inqas 5 ijiem għad-doża ta' 500 mg), mingħajr rapporti ta' deidratazzjoni, pressjoni baxxa jew żbilanċ fl-elettroliti, u mingħajr effett klinikament sinifikanti fuq l-intervall QTc.
English: • Dehydration: loss of too much fluid from your body, seen uncommonly (may affect up to 1 in 100 people).
Maltese: • Deidrazzjoni: telf eċċessiv ta' fluwidu mill-ġisem tiegħek, li jidher b'mod mhux komuni (jista' jaffettwa sa persuna 1 minn kull 100 persuna).
English: Taking this medicine
Maltese: Mediċini oħra u Xigduo
English: For patients switching from separate tablets of dapagliflozin and metformin Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to Xigduo should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Maltese: Għal pazjenti li jaqilbu minn pilloli separati ta' dapagliflozin u metformin Pazjenti li jaqilbu minn pilloli separati ta' dapagliflozin (doża totali ta' kuljum ta' 10 mg) u metformin għal Xigduo għandhom jirċievu l-istess doża ta' kuljum ta' dapagliflozin u metformin li diġà tkun qiegħda tittieħed jew l-eqreb doża terapewtikament xierqa ta' metformin.
English: The same recommendations for renal function apply to elderly patients as to all patients (see sections 4.2, 4.4, 4.8 and 5.1).
Maltese: L-istess rakkomandazzjonijiet għall-funzjoni renali japplikaw għal pazjenti akbar fl-età bħal fil-każ tal-pazjenti kollha (ara sezzjonijiet 4.2, 4.4, 4.8 u 5.1).
English: The efficacy of dapagliflozin was assessed in a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2 who had inadequate glycaemic control on usual care.
Maltese: L-effikaċja ta' dapagliflozin ġiet ivvalutata fi studju dedikat f'pazjenti dijabetiċi b'eGFR ≥ 45 sa < 60 mL/min/1.73 m2 li kellhom kontroll gliċemiku inadegwat bil-kura tas-soltu.
English: Increased creatinine
Maltese: All-cause mortality
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Maltese: Saru osservazzjonijiet simili għall-kombinazzjoni ta' dapagliflozin ma' metformin f'pazjenti li ma ħadux mediċini preċedentement.
English: Oral use bottle (glass)
Maltese: Użu orali flixkun (ħġieġ)
English: 13 g
Maltese: 13 g flixkun wieħed
English: The full EPAR for Alofisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Alofisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Alofisel jinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Alofisel.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Alofisel.
English: Other information about Alofisel
Maltese: Informazzjoni oħra dwar Alofisel
English: Of the patients treated with Alofisel, combined remission occurred in almost 50% of patients (53 out of 107); this compared with 34% of patients (36 out of 105) receiving placebo.
Maltese: Fost il-pazjenti li ġew ikkurati b'Alofisel, remissjoni kombinata seħħet fi kważi 50 % tal-pazjenti (53 minn 107); dan imqabbel ma' 34 % tal-pazjenti (36 minn 105) li ngħataw il-plaċebo.
English: Data on the safety of Alofisel are limited but they provide enough information on the pattern of side effects.
Maltese: Id-data dwar is-sigurtà ta' Alofisel hija limitata iżda tipprovdi biżżejjed informazzjoni dwar it-tendenza tal-effetti sekondarji.
English: Why is Alofisel approved?
Maltese: Għaliex ġie approvat Alofisel?
English: How does Alofisel work?
Maltese: Alofisel jingħata darba biss.
English: Because the number of patients with anal fistula is low, the disease is considered ‘rare', and Alofisel was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn fistula anali huwa baxx, il-marda hija kkunsidrata ‘rari', u Alofisel ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-8 ta' Ottubru 2009.
English: What are the risks associated with Alofisel?
Maltese: X'inhuma r-riskji assoċjati ma' Alofisel?
English: The main measure of effectiveness, called ‘combined remission', was the closing of abnormal external openings together with lack of fluid collections of more than 2 cm associated with internal passages (since these are likely to re-open the fistula).
Maltese: Il-miżura ewlenija ta' effettività, imsejħa ‘remissjoni kombinata', kienet l-għeluq ta' fetħiet esterni anormali flimkien ma' nuqqas ta' passaġġi interni akbar minn 2 ċm mimlija bi fluwidu (minħabba li dawn x'aktarx jiftħu l-fistula mill-ġdid).
English: The most common side effects with Alofisel (which may affect up to 1 in 10 people) are anal abscess (a swollen area with a collection of pus), proctalgia (anal pain), anal fistula and pain during treatment.
Maltese: L-effetti sekondarji l-aktar komuni b'Alofisel (li jistgħu jaffettwaw sa persuna waħda minn kull 10) huma axxessi anali (parti minfuħa bl-akkumulazzjoni ta' materja), proktalġja (uġigħ anali), fistula anali u uġigħ waqt il-kura.
English: Alofisel is made up of ‘mesenchymal stem cells' from the fat tissue of a donor.
Maltese: Alofisel huwa magħmul minn ‘ċelloli staminali mesenkimali' mit-tessut l-oħxon ta' donatur.
English: Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease (an inflammatory condition of the gut) when a conventional or biological medicine has not worked well enough.
Maltese: Alofisel huwa mediċina li tintuża biex tikkura fistuli anali kumplessi fl-adulti bil-marda Crohn (kundizzjoni infjammatorja tal-musrana) meta mediċina konvenzjonali jew bijoloġika ma tkunx ħadmet tajjeb biżżejjed.
English: One main study, involving 212 patients with Crohn's disease and complex anal fistulas, found Alofisel more effective than placebo (a dummy treatment) 24 weeks after treatment.
Maltese: Studju ewlieni wieħed, li jinvolvi 212-il pazjent bil-marda Crohn u fistuli anali kumplessi, sab li Alofisel huwa aktar effettiv mill-plaċebo (kura finta) 24 ġimgħa wara l-kura.
English: Fistulas are abnormal passages between the lower parts of the gut and the skin near the anus.
Maltese: Fistuli huma passaġġi anormali bejn il-partijiet t'isfel tal-musrana u l-ġilda qrib l-anus.
English: The company will also complete a study to continue to collect information on the effectiveness and safety of Alofisel.
Maltese: Ilkumpanija se ttemm ukoll studju biex tkompli tiġbor informazzjoni dwar l-effettività u s-sigurtà ta' Alofisel.
English: Alofisel contains the active substance darvadstrocel, which comprises stem cells removed from fat tissue of adult donors.
Maltese: Alofisel fih is-sustanza attiva darvadstrocel, li tinkludi ċelloli staminali li jitneħħew mit-tessuti taxxaħam ta' donaturi adulti.
English: After preparing the fistulas for treatment in an operating room, the contents of two vials (each containing 30 million cells) are injected around the internal openings and two further vials through the external openings into the walls of the fistula.
Maltese: Wara li l-fistuli jitħejjew għall-kura f'sala operattiva, il-kontenut ta' żewġ kunjetti (b'kull wieħed ikun fih 30 miljun ċellola) jiġi injettat mad-dawra tal-fetħiet interni u żewġ kunjetti oħra mill-fetħiet esterni fil-ħitan tal-fistula.
English: The company that markets Alofisel will provide educational material for healthcare professionals on how to give the medicine correctly and on the possibility of passing on an infection to the patient.
Maltese: Il-kumpanija li tqiegħed Alofisel fis-suq se tipprovdi materjal edukattiv għall-professjonisti tal-kura tassaħħa dwar kif suppost għandha tingħata l-mediċina u dwar il-possibbiltà li l-pazjent jiġi infettat.
English: It is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Maltese: Huwa tip ta' mediċina terapewtika avvanzata msejħa ‘prodott terapewtiku ta' ċellola somatika'.
English: Alofisel must not be used in patients with hypersensitivity (allergy) to bovine serum (the clear liquid in blood from cattle) or to any of the ingredients of Alofisel.
Maltese: Alofisel ma għandux jintuża f'pazjenti b'sensittività eċċessiva (allerġija) għas-serum tal-bovini (illikwidu ċar fid-demm mill-baqar) jew għal kwalunkwe wieħed mill-ingredjenti ta' Alofisel.
English: What measures are being taken to ensure the safe and effective use of Alofisel?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Alofisel?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: Pack size
Maltese: (doża ta'
English: 30 film-coated tablets in blisters
Maltese: 5 mg / 10 mg Pillolamiksija b'rita Użu orali
English: Prandin is a medicine that contains the active substance repaglinide.
Maltese: Prandin huwa mediċina li fiha s-sustanza attiva repaglinide.
English: A total of 2,156 patients received Prandin in all trials combined.
Maltese: Total ta' 2,156 pazjent irċievew Prandin fil-provi kollha kkombinati.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRANDIN EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) PRANDIN Sommarju tal-EPAR għall-pubbliku
English: The recommended starting dose is 0.5 mg.
Maltese: Id-doża tal-bidu rakkomandata hija 0.5 mg.
English: The marketing authorisation was renewed on 18 August 2003 and on 18 August 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-18 ta' Awwissu 2003 u fit-18 ta' Awwissu 2008.
English: Prandin is taken before meals, normally up to 15 minutes before each main meal.
Maltese: Prandin jittieħed qabel l-ikel, normalment sa 15-il minuta qabel kull ikla prinċipali.
English: Other information about Prandin:
Maltese: Informazzjoni oħra dwar Prandin:
English: It is available as round tablets (white: 0.5 mg; yellow: 1 mg; peach: 2 mg).
Maltese: Tiġi bħala pilloli tondi (bojod: 0.5 mg; sofor: 1 mg; lewn il-ħawħ:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prandin to Novo Nordisk A/S on 29 January 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq madwar l-Unjoni Ewropea, għal Prandin lil Novo Nordisk A/S fid-29 ta' Jannar 2001.
English: Prandin has been studied in 45 ‘clinical pharmacology' studies (looking at how the medicine works in the body) and 16 clinical trials (looking at its effects in treating type 2 diabetes patients).
Maltese: Prandin ġie studjat f'45 studju ta' ‘farmakoloġija klinika' (studju ta' kif taħdem il-mediċina fil-ġisem) u f'16-il prova klinika (studju tal-effetti tagħha fit-trattament ta' pazjenti b'dijabete tat-tip 2).
English: The most common side effects with Prandin (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea.
Maltese: L-aktar effetti sekondarji komuni ma' Prandin (li jidhru f'bejn pazjent 1 u 10 minn kull 100) huma lipogliċemija (livelli baxxi ta' glukożju fid-demm), uġigħ addominali (ta' żaqq) u dijarrea.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Prandin is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Maltese: Prandin mhuwiex rakkomandat għal pazjenti li għandhom inqas minn 18-il sena minħabba nuqqas ta' informazzjoni dwar is-sigurtà u l-effikaċja f'dan il-grupp ta' età.
English: Why has Prandin been approved?
Maltese: Għaliex ġie approvat Prandin?
English: This summary was last updated in 07-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 07-2008.
English: What is Prandin?
Maltese: Kif jintuża Prandin?