FrancophonIA/ELRC3.0 huggingface dataset:
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins (see section 4.4).
Maltese: It-tikketta tal-insulina għandha dejjem tiġi ċċekkjata qabel kull injezzjoni biex jiġu evitati żbalji ta' medikazzjoni bejn insulin glargine u insulini oħra (ara sezzjoni 4.4).
English: When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Maltese: Meta jingħata minn ġol-vina, il-half-life ta' eliminazzjoni ta' insulin glargine u tal-insulina umana kienu komparabbli.
English: Switch from twice daily NPH insulin to LUSDUNA
Maltese: Bidla minn insulina NPH darbtejn kuljum għal LUSDUNA
English: Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
Maltese: reazzjoni fil-post tal-injezzjoni) u reazzjonijiet fil-ġilda (raxx, urtikarja) fit-tfal u fl-adolexxenti (età ≤ 18-il sena) meta mqabbla mal-adulti.
English: The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor.
Maltese: Il-konċentrazzjoni terapewtika totali tal-insulina (insulin glargine u l-metaboliti tiegħu) li nstabet f'pazjenti dijabetiċi tat-tip 1 kienet ħafna inqas milli hemm bżonn sabiex tintlaħaq nofs l-okkupazzjoni massima tar-riċettur ta' IGF-1 u l-attivazzjoni sussegwenti tas-sensiela ta' reazzjonijiet mitoġeniċi proliferattivi mibdija mir-riċettur ta' IGF-1.
English: EU/1/16/1162/003 5 pre-filled pens of 3 mL
Maltese: EU/1/16/1162/003 5 pinen mimlijin għal-lest ta' 3 mL
English: In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal.
Maltese: Fi studju kliniku kkontrollat, fejn l-individwi ntagħżlu b'mod każwali, pazjenti tfal (firxa ta' etajiet minn 6 snin sa 15-il sena) bid-dijabete tat-tip I (n=349) ġew ittrattati għal 28 ġimgħa bi skeda ta' insulina basal-bolus fejn ġiet użata insulina regolari umana qabel kull ikla.
English: Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine.
Maltese: Ilkonċentrazzjonijiet għalhekk kienu konsisteni mal-profil tal-ħin tal-attività farmakodinamika ta' insulin glargine.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva
English: Insulin glargine was administered once daily at bedtime and NPH human insulin was administered once or twice daily.
Maltese: Insulin glargine ingħata darba kuljum fil-ħin tal-irqad u insulina umana NPH ingħatat darba jew darbtejn kuljum.
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbigħ b'mod separat.
English: Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.
Maltese: Insulin glargine injettat darba kuljum jilħaq livelli fissi u stabbli fi żmien 2-4 ijiem wara l-ewwel doża.
English: Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms (see section 4.4).
Maltese: Ġeneralment, aktar ma jkun hemm tnaqqis fil-glukosju fid-demm u aktar ma dan ittnaqqis ikun mgħaġġel, aktar ikun jidher il-fenomenu ta' kontroregolazzjoni u s-sintomi tiegħu (ara sezzjoni 4.4).
English: Effects of insulin glargine (once daily) on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography.
Maltese: L-effetti ta' insulin glargine (darba kuljum) fuq retinopatija tad-dijabete ġew evalwati f'1,024 pazjent b'dijabete tat-tip 2 fi studju ta' ħames snin, fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema sustanza qed tintuża, b'NPH bħala kontroll (NPH ingħata darbtejn kuljum) fejn kienet investigata il-progressjoni tar-retinopatija bi 3 gradi jew aktar fuq l-iskala tal-iStudju Dwar Retinopatija tad-Dijabete bi Trattament Bikri (ETDRS - Early Treatment Diabetic Retinopathy Study) permezz ta' ritratti tal-fundus.
English: The Nexvue pen delivers LUSDUNA in increments of 1 unit up to a maximum single dose of 60 units.
Maltese: Din il-pinna tħallik iddawwar doża bejn unità 1 u 60 unità.
English: Over the course of this 6-year study, 42 % of the insulin glargine group did not experience any hypoglycaemia.
Maltese: Matul il-kors kollu ta' dan l-istudju li dam 6 snin, 42% tal-grupp ta' insulin glargine ma kellhom l-ebda ipogliċemija.
English: Switch from other insulins to LUSDUNA
Maltese: Bidla minn insulini oħra għal LUSDUNA
English: LUSDUNA and medicinal products containing insulin glargine 300 units/mL are not bioequivalent and are not directly interchangeable.
Maltese: LUSDUNA u prodotti mediċinali li fihom insulin glargine 300 unità/mL mhumiex bijoekwivalenti u wieħed ma jistax jinbidel b'mod dirett mal-ieħor.
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Maltese: Ħu immedjatament madwar 10 sa 20 g zokkor, bħal glukosju, dadi tazzokkor, jew xi xarba ħelwa li fiha z-zokkor.
English: In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups.
Maltese: Fi studji kliniċi, l-antikorpi li jirreaġixxu kemm mal-insulina umana kif ukoll ma' insulin glargine ġew osservati bl-istess frekwenza kemm fil-grupp ta' trattament b'insulina NPH kif ukoll f'dak b'insulin glargine.
English: LUSDUNA can be used in adolescents and children aged 2 years and above.
Maltese: LUSDUNA jista' jintuża fl-adolexxenti u fit-tfal li għandhom età ta' sentejn u aktar.
English: - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever), - somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone), - sulphonamide antibiotics.
Maltese: - pentoxifylline, propoxyphene, salicylates (bħal acetylsalicylic acid, użati biex itaffu l-uġigħ u jnaqqsu d-deni), - analogi ta' somatostatin (bħal octreotide, użati biex jittrattaw kondizzjoni mhux komuni fejn inti tipproduċi wisq ormon tat-tkabbir), - antibijotiċi sulphonamide.
English: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
Maltese: Insulin glargine huwa insulina analoga għal dik umana imfassla b'mod li tinħall ftit f'pH newtrali.
English: HYPERGLYCAEMIA (high blood sugar levels)
Maltese: IPERGLIĊEMIJA (livelli għolja ta' zokkor fid-demm)
English: This is a modified insulin, very similar to human insulin.
Maltese: Din hija insulina modifikata, simili ħafna għall-insulina tal-bniedem.
English: Although LUSDUNA contains the same active substance as other medicines containing insulin glargine 300 units/ml, these medicines are not interchangeable.
Maltese: Għalkemm LUSDUNA fih l-istess sustanza attiva bħal mediċini oħra li fihom insulin glargine 300 unità/ml, dawn il-mediċini ma jistgħux jinbidlu waħda mal-oħra.
English: Plasma “trough” levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
Maltese: Il-livelli l-aktar baxxi ta' insulin glargine u lmetaboliti prinċipali tiegħu M1 u M2 fil-plażma kienu mkejla fi tfal ittrattati b'insulin glargine, u żvelaw li l-mudelli tal-konċentrazzjoni fil-plażma huma simili għal tal-adulti, u ma pprovdew l-ebda evidenza ta' akkumulazzjoni ta' insulin glargine jew il-metaboliti tiegħu meta jingħataw dożi għal tul ta' żmien.
English: Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
Maltese: L-insulina tinibixxi l-lipolisi fl-adipoċita, tinibixxi l-proteolisi u ttejjeb is-sintesi tal-proteini.
English: Secondary endpoints included all-cause mortality and a composite microvascular outcome.
Maltese: L-iskopijiet sekondarji finali kienu jinkludu mewt minn kwalunkwe kawża u riżultat kompost mikrovaskulari.
English: Tell your relatives, friends and close colleagues the following:
Maltese: Għid lill-qrabatek, lill-ħbiebek u lill-kollegi qrib tiegħek dan li ġej:
English: Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include largescale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating.
Maltese: Reazzjonijiet allerġiċi serji (rari, jistgħu jaffettwaw sa persuna 1 minn kull 1,000) - is-sinjali jistgħu jinkludu reazzjonijiet fil-ġilda fuq skala kbira (raxx u ħakk mal-ġisem kollu), nefħa severa fil-ġilda jew fil-membrani mukużi (anġjoedima), qtugħ ta' nifs, il-pressjoni titbaxxa b'taħbit tal-qalb mgħaġġel u ħruġ ta' għaraq.
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Maltese: Eżempji ta' sintomi li jindikaw livell baxx ta' zokkor fil-moħħ: uġigħ ta' ras, ġuħ kbir, dardir, rimettar, għeja, ngħas, disturbi fl-irqad, nuqqas ta' kwiet, komportament aggressiv, telf ta' konċentrazzjoni, reazzjonijiet indeboliti, depressjoni, konfużjoni, disturbi fid-diskors, (xi drabi telf komplut taddiskors), disturbi fil-vista, rogħda, paraliżi, jinħass tnemnim (paresteżija), jinħass titrix u tnemnim qrib il-ħalq, sturdament, ma tkunx tista' trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u telf mis-sensi.
English: Warning symptoms of hypoglycaemia
Maltese: Sintomi ta' twissija tal-ipogliċemija
English: In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Maltese: F'pazjenti li għandhom retinopatija proliferattiva, speċjalment meta ma tkunx ittrattata b'fotokoagulazzjoni, episodji severi ta' ipogliċemija jistgħu jwasslu għal amawrosi temporanja.
English: Insulin cartridge dose window injection button
Maltese: Insulin glargine jiġi metabolizzat f'żewġ metaboliti attivi
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Maltese: Fl-anzjani, id-deterjorament progressiv tal-funzjoni tal-kliewi jista' jwassal għal tnaqqis b'mod kostanti fil-ħtiġijiet tal-insulina.
English: This leaflet was last revised in.
Maltese: Tużax il-pinna tiegħek wara d-data ta' meta tiskadi.
English: Similar effects on glycohaemoglobin and the incidence of symptomatic hypoglycaemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group.
Maltese: Fiż-żewġ gruppi ta' trattament ġew osservati effetti simili fuq il-glikoemoglobina u fl-inċidenza ta' ipogliċemija bis-sintomi, madankollu kien hemm tnaqqis akbar mil-linja bażi fil-livell tal-glukosju fil-plażma flistat ta' sawm fil-grupp ta' insulin glargine milli fil-grupp ta' NPH. Kien hemm ukoll inqas ipogliċemija severa fil-grupp ta' insulin glargine.
English: Do not inject insulin.
Maltese: Formazzjoni ta' antikorpi għall-insulina
English: LUSDUNA 100 units/mL solution for injection in a pre-filled pen Insulin glargine
Maltese: LUSDUNA 100 unità/mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Insulin glargine
English: Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in LUSDUNA therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
Maltese: Il-konċentrazzjonijiet fiżjoloġiċi ta' IGF-1 endoġenu jistgħu jattivaw is-sensiela ta' reazzjonijiet mitoġeniċi proliferattivi; madankollu, ilkonċentrazzjonijiet terapewtiċi li jistabu fit-terapija bl-insulina, inkluż it-terapija b'LUSDUNA, huma ħafna inqas mill-konċentrazzjonijiet farmakoloġiċi li hemm bżonn sabiex tiġi attivata s-sensiela ta' reazzjonjiet ta' IGF-1.
English: In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
Maltese: F'persuni f'saħħithom u f'pazjenti dijabetiċi, il-konċentrazzjonijiet tal-insulina fis-serum indikaw assorbiment aktar bil-mod u ħafna aktar fit-tul u wrew nuqqas ta' konċentrazzjoni għolja, wara injezzjoni taħt il-ġilda ta' insulin glargine meta mqabbla mal-insulina NPH umana.
English: Insulin administration may cause insulin antibodies to form.
Maltese: L-għoti tal-insulina jista' jikkawża l-formazzjoni ta' antikorpi għall-insulina.
English: Combination of LUSDUNA with pioglitazone
Maltese: Kif jidher LUSDUNA u l-kontenut tal-pakkett
English: Due to more sustained basal insulin supply with insulin glargine, less nocturnal but more early morning hypoglycaemia can be expected.
Maltese: Meta insulin glargine tqabbel mal-insulina NPH, ma dehritx differenza sinifikanti fil-progressjoni ta' retinopatija tad-dijabete.
English: Tell a doctor straight away if you notice signs of severe allergic reaction.
Maltese: F'dan l-istudju ma ġewx osservati sinjali ġodda dwar sigurtà.
English: In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Maltese: Fi studju kliniku, is-sintomi tal-ipogliċemija jew ir-risponsi kontroregolatorji tal-ormoni kienu simili wara insulin glargine u insulina umana mogħtija fil-vina, kemm f'voluntiera f'saħħithom kif ukoll f'pazjenti bid-dijabete tat-tip 1.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Maltese: Mediċini użati fid-dijabete, insulini u analogi tagħhom għallinjezzjoni, azzjoni fit-tul.
English: Carefully read the instructions for use included in the pack before using Nexvue.
Maltese: Aqra b'attenzjoni l-istruzzjonijiet dwar l-użu inklużi fil-pakkett qabel tuża Nexvue.
English: In use
Maltese: JIS
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondari rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000)
English: Switching insulins
Maltese: Użu ta' insulina flok oħra
English: If the hypoglycaemia comes back again, take another 10 to 20 g sugar.
Maltese: Jekk l-ipogliċemija terġa' tfiġġ, erġa' ħu minn 10 sa 20 g ta' zokkor.
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 5.1).
Maltese: F'każijiet rari, ilpreżenza ta' tali antikorpi għall-insulina tista' tkun teħtieġ aġġustament fid-doża tal-insulina sabiex tirregola tendenza ta' ipergliċemija jew ipogliċemija (ara sezzjoni 5.1).
English: These measures will help protect the environment.
Maltese: Tista' ddum tipprova ħames darbiet.
English: To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with LUSDUNA should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment.
Maltese: Biex jitnaqqas ir-riskju ta' ipogliċemija matul il-lejl u filgħodu kmieni, il-pazjenti li qed jibdlu l-kors tal-insulina tal-bażi tagħhom minn insulina NPH darbtejn kuljum għal kors ta' darba kuljum b'LUSDUNA, għandhom inaqqsu d-doża ta' kuljum tagħhom tal-insulina tal-bażi b'20-30 %, waqt lewwel ġimgħat ta' trattament.
English: Very rare side-effects (may affect up to1 in 10,000 people) In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Maltese: F'każijiet rari ħafna, jistgħu jseħħu disgewżja (disturbi fit-togħma) u majalġja (uġigħ fil-muskoli).
English: Further information on Pradaxa 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 ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This overview was last updated in 12-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi 12-2019.
English: Pradaxa received a marketing authorisation valid throughout the EU on 18 March 2008.
Maltese: Pradaxa rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-18 ta' Marzu 2008.
English: Pradaxa contains the active substance dabigatran etexilate.
Maltese: Pradaxa fih is-sustanza attiva dabigatran etexilate.
English: Other information about Pradaxa
Maltese: Informazzjoni oħra dwar Pradaxa
English: Pradaxa is an anticoagulant medicine used for:
Maltese: Pradaxa huwa mediċina antikoagulanti li tintuża għal:
English: What are the risks associated with Pradaxa?
Maltese: X'inhuma r-riskji assoċjati ma' Pradaxa?
English: The second study involved a total of 3,494 patients who had had a hip replacement.
Maltese: It-tieni studju involva total ta' 3,494 pazjent li kellhom sostituzzjoni tal-ġenb.
English: Pradaxa (110 mg or 150 mg twice a day) was as effective as warfarin (another anticoagulant given by mouth) in preventing stroke or a blood clot blocking blood vessels in other parts of the body in a study of patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.
Maltese: Pradaxa (110 mg jew 150 mg darbtejn kuljum) kien effettiv daqs warfarin (antikoagulant ieħor mogħti mill-ħalq) fil-prevenzjoni ta' puplesija jew embola tad-demm li timblokka l-vażi f'partijiet oħra talġisem fi studju ta' pazjenti b'fibrillazzjoni atrijali mhux valvulari li kienu kkunsidrati li huma f'riskju ta' puplesija.
English: The active substance in Pradaxa, dabigatran etexilate, is a ‘prodrug' of dabigatran.
Maltese: Is-sustanza attiva f'Pradaxa, dabigatran etexilate, hija “promediċina” ta' dabigatran.
English: The proportion of patients who had a stroke or other problems caused by blood clots each year was around 1.5% for patients taking 110 mg Pradaxa (183 patients out of 6,015) and 1.1% for patients taking 150 mg Pradaxa (135 out of 6,076), compared with 1.7% for patients taking warfarin (203 out of 6,022).
Maltese: Il-proporzjon ta' pazjenti li kellhom puplesija jew problemi oħra kkawżati minn emboli tad-demm kull sena kien ta' madwar 1.5 % għall-pazjenti li kienu qed jieħdu 110 mg Pradaxa (183 pazjent minn 6,015) u 1.1 % għall-pazjenti li kienu qed jieħdu 150 mg Pradaxa (135 minn 6,076), meta mqabbla ma' 1.7 % għall-pazjenti li kienu qed jieħdu warfarin (203 minn 6,022).
English: • preventing stroke and the formation of clots in adults who have an abnormal heartbeat called ‘nonvalvular atrial fibrillation' and are considered to be at risk of stroke;
Maltese: • il-prevenzjoni ta' puplesija u l-formazzjoni ta' emboli tad-demm f'adulti li għandhom taħbit tal-qalb anormali msejjaħ “fibrillazzjoni atrijali mhux valvulari” u li jitqiesu li huma f'riskju ta' puplesija;
English: The first study involved a total of 2,101 patients who had had a knee replacement operation.
Maltese: L-ewwel studju involva total ta' 2,101 pazjent li kellhom operazzjoni ta' sostituzzjoni tal-irkoppa.
English: In both studies, there was some evidence that a 220 mg dose of Pradaxa may be more effective than a 150 mg dose.
Maltese: Fiż-żewġ studji, kien hemm xi evidenza li doża ta' 220 mg ta' Pradaxa tista' tkun aktar effettiva minn doża ta' 150 mg.
English: However, the number of bleeding events was lower for Pradaxa than for warfarin.
Maltese: Madankollu, in-numru ta' avvenimenti ta' fsada kien aktar baxx għal Pradaxa milli għal warfarin.
English: Pradaxa is available as capsules (75, 110 and 150 mg) and can only be obtained with a prescription.
Maltese: Pradaxa jiġi bħala kapsuli (75, 110 u 150 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: It blocks a substance called thrombin, which is central to the process of blood clotting.
Maltese: Dan jimblokka sustanza msejħa trombina, li hija importanti għall-proċess talkoagulazzjoni tad-demm.
English: Pradaxa (220 or 150 mg a day) was as effective as enoxaparin (an anticoagulant given by injection) in preventing formation of blood clots or death in patients who had undergone hip or knee replacement in two main studies.
Maltese: Pradaxa (220 jew 150 mg kuljum) kien effettiv daqs enoxaparin (antikoagulant mogħti b'injezzjoni) filprevenzjoni tal-formazzjoni ta' emboli tad-demm jew mewt f'pazjenti li saritilhom sostituzzjoni tal-ġenb jew tal-irkoppa f'żewġ studji ewlenin.
English: • treating deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (PE, a clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again.
Maltese: • il-kura ta' trombożi fil-vini profondi (DVT, embolu tad-demm ġo vina profonda, normalment firriġel) u emboliżmu pulmonari (PE, embolu ġo vażu li jforni l-pulmun), f'adulti, u biex tipprevjeni milli jerġgħu jseħħu dawn il-kondizzjonijiet.
English: During the treatment period, blood clots were detected in 36% of the patients taking 220 mg Pradaxa (183 out of 503), compared with 38% of the patients receiving enoxaparin (193 out of 512).
Maltese: Matul il-perjodu tal-kura, l-emboli tad-demm instabu f'36 % tal-pazjenti li kienu qed jieħdu 220 mg Pradaxa (183 minn 503), meta mqabbla ma' 38 % tal-pazjenti li ngħataw enoxaparin (193 minn 512).
English: Blood clots or blood-clot-related death occurred in 2.7% (68 out of 2,553) of patients treated with Pradaxa, compared with 2.4% (62 out of 2,554) of patients treated with warfarin.
Maltese: L-emboli tad-demm jew mewt relatata mal-koagulazzjoni tad-demm seħħet fi 2.7 % (68 minn 2,553) tal-pazjenti ttrattati bi Pradaxa, meta mqabbel ma' 2.4 % (62 minn 2,554) tal-pazjenti kkurati b'warfarin.
English: During the treatment period, blood clots were detected in 6% of the patients taking 220 mg Pradaxa (53 out of 880), compared with 7% of the patients receiving enoxaparin (60 out of 897).
Maltese: Matul il-perjodu tal-kura, l-emboli tad-demm instabu f'6 % tal-pazjenti li kienu qed jieħdu 220 mg Pradaxa (53 minn 880), meta mqabbla ma' 7 % tal-pazjenti li ngħataw enoxaparin (60 minn 897).
English: As for all medicines, data on the use of Pradaxa are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Pradaxa hija ssorveljata kontinwament.
English: In the first study, blood clots or blood-clot-related death occurred in 1.8% (26 out of 1,430) of patients treated with Pradaxa, compared with 1.3% (18 out of 1,426) of patients treated with warfarin.
Maltese: Fl-ewwel studju, l-emboli taddemm jew il-mewt relatata mal-koagulazzjoni tad-demm seħħew f'1.8 % (26 minn 1,430) tal-pazjenti kkurati bi Pradaxa, meta mqabbla ma' 1.3 % (18 minn 1,426) tal-pazjenti kkurati b'warfarin.