FrancophonIA/ELRC3.0 huggingface dataset:
English: • mantle cell lymphoma (a cancer of B cells, a type of white blood cell).
Maltese: • linfoma taċ-ċelloli mantellari (kanċer taċ-ċelloli B, tip ta' ċellola bajda tad-demm).
English: Patients receiving the lower dose of Torisel in combination with interferon alfa survived for a similar time (8.4 months) as those taking interferon alfa alone.
Maltese: Il-pazjenti li ngħataw doża mnaqqsa ta' Torisel flimkien ma' interferon alfa għexu tul ta' żmien simili (8.4 xhur) bħal dawk li ħadu l-interferon alfa waħidha.
English: In mantle cell lymphoma, Torisel was found more effective than alternative cancer medicines (such as gemcitabine or fludarabine) in a main study involving 162 patients whose disease had come back after previous treatment or in whom other treatments had not worked.
Maltese: Fil-linfoma taċ-ċelloli mantellari, Torisel instab li kien aktar effettiv minn mediċini alternattivi kontra lkanċer (bħal gemcitabine jew fludarabine) fi studju ewlieni li involva 162 pazjent li l-marda tagħhom reġgħet tfaċċat wara li diġà kienu ħadu l-kura jew f'dawk li l-kuri l-oħra ma rnexxewx.
English: In advanced renal cell carcinoma, a main study involving 626 patients with poor prognosis found Torisel more effective than interferon alfa (another medicine used in the treatment of cancer) at prolonging patients' survival.
Maltese: Fil-karċinoma avvanzata taċ-ċelloli renali, studju ewlieni li involva 626 pazjent bi pronjożi batuta sab lil Torisel huwa aktar effettiv minn interferon alfa (mediċina oħra li tintuża fil-kura tal-kanċer) biex tittawwal is-sopravivenza tal-pazjenti.
English: What are the risks associated with Torisel?
Maltese: Kif jaħdem Torisel?
English: Torisel must not be used in people who are hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine.
Maltese: Torisel ma għandux jintuża minn nies li jkunu ipersensittivi (allerġiċi) għat-temsirolimus, għallmetaboliti tiegħu (is-sustanzi li jitkisser fihom) fosthom is-sirolimus (mediċina użata fil-prevenzjoni tarrifjut tal-kliewi trapjantati), għall-polisorbat 80 jew għal kwalunkwe ingredjent ieħor tal-mediċina.
English: Torisel must not be used in patients with mantle cell lymphoma who have moderate or severe problems with their liver.
Maltese: Torisel mhux rakkomandat f'pazjenti morda bil-linfoma taċ-ċelloli mantellari li jkollhom problemi moderati jew serji fil-fwied.
English: For mantle cell lymphoma, the recommended dose is 175 mg once a week for three weeks, followed by weekly doses of 75 mg.
Maltese: Għal-linfoma taċċelloli mantellari, id-doża rrakkomandata hija 175 mg darba fil-ġimgħa għal tliet ġimgħat, segwita b'dożi ta' 75 mg darba fil-ġimgħa.
English: What measures are being taken to ensure the safe and effective use of Torisel?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Torisel?
English: • advanced renal cell carcinoma (a kidney cancer).
Maltese: • karċinoma avvanzata f'ċelloli renali (tip ta' kanċer tal-kliewi). “Avvanzat” tfisser li l-kanċer beda jinfirex;
English: For renal cell carcinoma, the recommended dose of Torisel is 25 mg once a week, but a 10-mg dose is recommended in patients with severe liver problems who have high levels of platelets in the blood.
Maltese: Għall-karċinoma taċ-ċelloli renali, id-doża rrakkomandata ta' Torisel hija 25 mg darba fil-ġimgħa, iżda għal pazjenti bi problemi gravi fil-fwied li jkollhom livelli għolja ta' pjastrini fid-demm, id-doża rrakkomandata hija 10 mg.
English: 4 vials + 4 ampoules
Maltese: 4 kunjetti + 4 ampoules
English: 10 (10x1) vials (multi-pack)
Maltese: 10 (10x1) kunjetti (pakkett multiplu)
English: 10 (10x 1+1) vials + ampoules (multi-pack)
Maltese: 10 (10x 1+1) kunjetti + ampoules (pakkett multiplu)
English: 1 vial + 1 ampoule
Maltese: 1 kunjett + 1 ampoule
English: 4 vials
Maltese: 4 kunjetti
English: Romania Alapis Romania s.r.l.
Maltese: Rumanija Alapis Romania s.r.l.
English: Bulgaria Alapis Bulgaria Ltd., 29, Atanas Dukov Str. 1407, Sofia,
Maltese: Bulgarija Alapis Bulgaria Ltd., 29, Atanas Dukov Str. 1407, Sofia,
English: Germany Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece
Maltese: Nikolaou street, 17671 Athens, Greece
English: Belgium Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece
Maltese: Ġermanja Alapis S.A., 2 Aftokratoros
English: Javlor vinflunine
Maltese: Javlor vinflunina
English: It contains the active substance vinflunine (25 mg/l).
Maltese: Fih is-sustanza attiva vinflunina (25 mg/l).
English: The full EPAR for Javlor can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Javlor jinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with Javlor (seen in more than 1 patient in 10) are neutropenia, leucopenia (low white blood cell counts), anaemia (low red blood cell counts), thrombocytopenia (low platelet count), loss of appetite, constipation, abdominal (stomach) pain, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), diarrhoea, alopecia (hair loss), myalgia (muscle pain), asthenia (weakness) or fatigue (tiredness), injection site reaction, fever and weight loss.
Maltese: L-effetti sekondarji l-aktar komuni b'Javlor (li dehru f'aktar minn pazjent 1 minn 10) huma newtropenija, lewkopenija (għadd baxx ta' ċelloli bojod fid-demm), anemija (għadd baxx ta' ċelloli ħomor fid-demm), tromboċitopenija (għadd baxx ta' pjastrini), telf ta' aptit, stitikezza, ugiġħ addominali (ta' żaqq), remettar, nawżja (dardir), stomatite (infjammazzjoni fil-kisi tal-ħalq), dijarrea, alopeċja (telf tax-xagħar), mijalġija (uġigħ fil-muskoli), astenija (debbulizza) jew għeja, reazzjonijiet fis-sit tal-injezzjoni, deni u telf tal-piż.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Javlor on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Javlor fil-21 ta' Settembru 2009.
English: This is a summary of the European public assessment report (EPAR) for Javlor.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Javlor.
English: The recommended dose is 320 mg per m2. Javlor is given as a drip into a vein over a period of
Maltese: Id-doża rakkomandata hija 320 mg għal kull m2.
English: Javlor is a concentrate for solution for infusion (drip into a vein).
Maltese: Javlor huwa konċentrat għal soluzzjoni għall-infużjoni (dripp fil-vina).
English: In this group, those given Javlor lived for 6.9 months compared with 4.3 months for patients who were not given the Javlor.
Maltese: F'dan il-grupp, dawk ittrattati b'Javlor għexu 6.9 xhur apparagun mal-4.3 xhur tal-pazjenti li ma kinux ittrattati b'Javlor.
English: The active substance in Javlor, vinflunine, belongs to the group of anticancer medicines known as the vinca alkaloids.
Maltese: Is-sustanza attiva f'Javlor, il-vinflunina, tappartjeni lill-grupp ta' mediċini kontra l-kanċer magħrufa bħala l-alkalojdi tal-vinka.
English: Why has Javlor been approved?
Maltese: Għaliex ġie approvat Javlor?
English: What is the risk associated with Javlor?
Maltese: X'inhu r-riskju assoċjat ma' Javlor?
English: In one main study of 370 adults with advanced or metastatic transitional cell carcinoma of the urothelial tract, patients who were given Javlor treatment were compared with patients who were not given any anticancer medicine.
Maltese: Fi studju wieħed ewlieni li sar fuq 370 adult b'karċinoma b'ċelloli tranżizzjonali tal-apparat uroteljali fi stadju avvanzat jew metastatiku, il-pazjenti li kienu qed jingħataw trattamet b'Javlor tqabblu ma' pazjenti li ma ngħataw l-ebda mediċina kontra l-kanċer.
English: It must not be used in patients who have or have had a severe infection within the past two weeks or in patients with a neutrophil count of less than 1,500 per mm for the first administration or less than 1,000/mm3 for subsequent administrations or a platelet count less than 100,000 per mm3.
Maltese: Ma għandux jintuża f'pazjenti li għandhom jew kellhom infezzjoni gravi fl-aħħar ġimagħtejn jew f'pazjenti b'għadd ta' newtrofili anqas minn 1,500 għal kull mm3 għall-ewwel amministrazzjoni jew anqas minn 1,000/mm3 għall-amministrazzjonijiet sussegwenti jew għadd ta' pjastrini anqas minn 100,000 għal kull mm3 Lanqas m'għandu jintuża minn ommijiet li jkunu qed ireddgħu.
English: Javlor is used for the treatment of adults with advanced or metastatic ‘transitional cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Maltese: Javlor jintuża fit-trattament ta' adulti li jbatu minn “karċinoma b'ċelloli tranżitorji tal-apparat uroteljali” (kanċer li jolqot il-kisi tal-bużżieqa tal-urina u l-bqija tal-apparat urinarju) fi stadju avvanzat jew metastatiku.
English: The CHMP decided that Javlor's benefits are greater than its risks and recommended that Javlor be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Javlor huma akbar mir-riskji tiegħu u għaldaqstasnt irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Other information about Javlor
Maltese: Aktar tagħrif dwar Javlor
English: For more information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju talkaratteristiċi tal-prodott (huwa parti wkoll mill-EPAR).
English: The doctor may also delay or stop doses if the patient experiences certain side effects, including low levels of platelets and neutrophils (a type of white blood cell), and certain side effects affecting the heart, liver or lungs.
Maltese: It-tabib jista' wkoll idewwem jew iwaqqaf id-dożi jekk il-pazjent iġarrab ċerti effetti sekondarji, fosthom livelli baxxi ta' pjastrini u newtrofili (tip ta' ċellola bajda fid-demm) u ċerti effetti sekondarji li jolqtu l-qalb, il-fwied jew il-pulmun.
English: Javlor with best supportive care was more effective than best supportive care alone in prolonging the lives of patients with advanced or metastatic transitional cell carcinoma of the urothelial tract.
Maltese: Fost il-pazjenti kollha li ħadu sehem fl-istudju ma kien hemm l-ebda prova ċara ta' differenza fis-sopravivenza bejn il-pazjenti li kienu ttrattati b'Javlor u dawk li ma kinux ittrattati bil-mediċina.
English: It attaches to a protein in cells called ‘tubulin', which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Maltese: Din teħel ma' proteina preżenti fiċ-ċelloli msejħa ‘tubulina', li hija importanti fil-formazzjoni tal-‘iskeletru' intern meħtieġ miċ-ċelloli biex jingħaqdu meta jinqasmu.
English: 1 pre-filled pen
Maltese: Pinna 1 mimlija għallest
English: The full EPAR for Forsteo 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: Forsteo is a medicine that contains the active substance teriparatide.
Maltese: Forsteo huwa mediċina li fiha s-sustanza attiva teriparatide.
English: It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.
Maltese: Naqqas ukoll ir-riskju ta' ksur mhux vertebrali bi 62%, iżda ma naqqasx ir-riskju tal-ksur tal-ġenbejn.
English: This is a summary of the European public assessment report (EPAR) for Forsteo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Forsteo.
English: The active substance in Forsteo, teriparatide, is identical to part of the human parathyroid hormone.
Maltese: Is-sustanza attiva f'Forsteo, it-teriparatide, hija identika għal parti minn l-ormon uman paratirojde.
English: Other information about Forsteo
Maltese: Informazzjoni oħra dwar Forsteo
English: The first study involved 1,637 women with osteoporosis who had been through the menopause (average age: 69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months.
Maltese: L-ewwel studju kien jinvolvi 1,637 mara bl-osteoporożi wara l-menopawża (età medja: 69.5 snin), fejn Forsteo tqabbel ma' plaċebo (kura finta) għal medja ta' 19-il xahar.
English: In the study of patients taking glucocorticoids, Forsteo was more effective than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.
Maltese: Fl-istudju ta' pazjenti li kienu qed jieħdu glukokortikojdi, Forsteo kien aktar effettiv minn alendronate: wara 18-il xahar, pazjenti li ngħataw Forsteo kellhom żieda ta' 7% fid-densità tal-għadam fl-ispina, meta mqabbel ma' 3% f'dak li ngħataw alendronate.
English: Why has Forsteo been approved?
Maltese: Għaliex ġie approvat Forsteo?
English: What is the risk associated with Forsteo?
Maltese: X'inhu r-riskju assoċjat ma' Forsteo?
English: The recommended dose is 20 micrograms of Forsteo given once a day as an injection under the skin of the thigh or abdomen (tummy).
Maltese: Id-doża rakkomandata hija 20 mikrogramma ta' Forsteo mogħtija darba kuljum bħala injezzjoni taħt ilġilda fil-koxxa jew fl-addome (żaqq).
English: It is available as a solution for injection in prefilled pens (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).
Maltese: Jiġi bħala soluzzjoni għall-injezzjoni f'pinen mimlija minn qabel (pinna waħda mimlija minn qabel ta' 2.4ml fiha 600 mikrogramma ta' teriparatide).
English: Forsteo must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Maltese: Forsteo m'għandux jintuża f'pazjenti li jkollhom mard ieħor tal-għadam bħall-marda tal-Paget, kanċer tal-għadam jew metastażi tal-għadam (kanċer li jkun infirex għall-għadam), pazjenti li kellhom terapija ta' radjazzjoni tal-iskeletru, jew pazjenti b'iperkalċemija (livelli għoljin ta' kalċju fid-demm), livelli għoljin mingħajr raġuni ta' alkaline phosphatase (enzim), jew mard serju tal-kliewi.
English: Forsteo was more effective than placebo in reducing vertebral fractures: 5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo.
Maltese: Forsteo kien aktar effettiv minn plaċebo fit-tnaqqis tal-ksur vertebrali: 5% tan-nisa li rċevew Forsteo kellhom ksur ġdid waqt l-istudju, meta mqabbel ma' 14.
English: An additional study looked at the effects of Forsteo on bone density over two years in 234 women who had been through the menopause.
Maltese: Studju ieħor addizzjonali ħares lejn l-effetti ta' Forsteo fuq id-densità tal-għadam fuq perjodu ta' sentejn f'234 mara li għaddew mill-menopawża.
English: Forsteo reduced the risk of developing a new vertebral fracture over 19 months by 65% compared with placebo.
Maltese: Forsteo naqqas ir-riskju ta' żvilupp ta' ksur vertebrali ġdid fuq id-19-il xahar b'65% meta mqabbel ma' plaċebo.
English: Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:
Maltese: Forsteo jintuża għall-kura tal-osteoporożi (marda li tagħmel l-għadam fraġli) fil-gruppi li ġejjin:
English: A user manual is available for the pen.
Maltese: Manwal għall-utent huwa disponibbli għall-pinna.
English: The study included 429 women and men who had osteoporosis and had been taking glucocorticoids for at least three months.
Maltese: L-istudju inkluda 429 mara u raġel li kellhom l-osteoporożi u kienu ilhom jieħdu glukokortikojdi għal tal-anqas tliet xhur.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Forsteo on 10 June 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Forsteo fl-10 ta' Ġunju 2003.
English: The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years.
Maltese: It-tielet studju qabbel l-effetti ta' Forsteo u alendronate (mediċina oħra użata għall-kura talosteoporożi) fuq id-densità tal-għadam tal-ispina tul tliet snin.
English: How does Forsteo work?
Maltese: Kif jintuża Forsteo?
English: What is Forsteo?
Maltese: X'inhu Forsteo?
English: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Maltese: Finnisa, l-osteoporożi hija aktar komuni wara l-menopawża, meta l-livelli tal-ormon tan-nisa, l-estroġenu, jaqgħu.
English: For the full list of all side effects reported with Forsteo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Forsteo, ara l-fuljett ta' tagħrif.
English: The CHMP concluded that Forsteo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Forsteo huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is Forsteo used for?
Maltese: Kif jaħdem Forsteo?
English: How has Forsteo been studied?
Maltese: Kif ġie studjat Forsteo?
English: It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells).
Maltese: Taġixxi bħall-ormon biex tistimula l-formazzjoni tal-għadam billi taġixxi fuq osteoblasts (ċelloli li jiffurmaw l-għadam).
English: The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.
Maltese: It-tieni studju ħares lejn l-użu ta' Forsteo f'437 raġel b'osteoporożi, u qabbel l-effett tiegħu maddensità tal-għadam fl-ispina ma' dak ta' plaċebo.
English: 6 seconds
Maltese: 6 sekondi
English: ATC code: A10AE06.
Maltese: A10AE06.
English: OTHER Novo Nordisk A/S
Maltese: Novo Nordisk A/S
English: EAC: Event adjudication committee.
Maltese: Kumitat ta' aġġudikazzjoni tal-avvenimenti (Event adjudication committee).
English: Hazard Ratio (95% CI)
Maltese: periklu (95% CI)
English: Insulin degludec (N26) (CV%)
Maltese: Insulina degludec (N26) (CV%)
English: Favours insulin glargine
Maltese: Favur insulin glargine
English: Date of latest renewal: 21 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Jannar 2013 Data tal-aħħar tiġdid: 21 Sttembru 2017
English: • danazol, for endometriosis
Maltese: • danazol, għall-endometrijosi
English: Favours Tresiba
Maltese: Favur Tresiba
English: Ratio: 3.81 [2.40; 6.05]
Maltese: Proporzjon: 3.81 [2.40;6.05]
English: • anabolic steroids, such as testosterone
Maltese: • sterojdi anaboliċi, bħal testosterone
English: Difference: -2.17 [-2.59; -1.74]
Maltese: Differenza: -2.17 [-2.59; -1.74]
English: • you have used an injection of glucagon
Maltese: • użajt injezzjoni ta' glucagon
English: Difference: -1.66 [-2.37; -0.95]
Maltese: Differenza: -1.66 [-2.37; -0.95]
English: CI: 95% confidence interval.
Maltese: IM: Infart mijokardijaku. CI: 95% interval ta' kunfidenza (confidence interval).
English: Estimated risk ratio (Insulin degludec/Insulin glargine)
Maltese: Stima tal-proporzjon tar-riskju (Insulina degludec /Insulina glargine )
English: • The active substance is insulin degludec.
Maltese: • Is-sustanza attiva hi insulina degludec.
English: If you have poor eyesight, please see section 3.
Maltese: Jekk għandek vista batuta, jekk jogħġbok ara sezzjoni 3.
English: Figure 1 Glucose infusion rate profile, smoothed, steady state - Mean profile 0-24 hours - IDeg 100 units/mL 0.6 units/kg - Trial 1987
Maltese: Figura 1 Profili tar-rata ta' infużjoni tal-glukosju, uniformi, stat fiss - Medja tal-profili 024 siegħa - IDeg 100 unitajiet/mL 0.6 unitajiet/kg - Prova 1987
English: Figure 2 Forest plot of analysis of the composite 3-point MACE and individual cardiovascular endpoints in DEVOTE
Maltese: 2 Forest plott ta' analiżi tat-taħlita tat-3-komponenti ta' MACE u punti finali individwali kardjovaskulari f'DEVOTE
English: For more information, see ‘serious allergic reaction' above.
Maltese: Għal aktar informazzjoni, ara ‘reazzjoni allerġika serja' taħt.
English: 6 The ratio is for Tresiba Flex/Tresiba.
Maltese: Il-proporzjoni hi għal Tresiba Flex/Tresiba.
English: At baseline, HbA1c was 8.4% in both treatment groups and after 2 years HbA1c was 7.5% both with Tresiba and insulin glargine.
Maltese: Fil-linja bażi, HbA1c kien 8.4% fiż-żewġ gruppi ta' trattamenti u wara sentejn HbA1c kien 7.5% kemm b'Tresiba u kemm b'insulin glargine.
English: Elderly, race, renal and hepatic impairment
Maltese: Anzjani, razza, indeboliment renali u epatiku
English: Glucose Infusion Rate (mg/(kg*min))
Maltese: Rata ta' Infużjoni tal-Glukożju (kg*min)
English: Primary analysis (3-point MACE) CV Death
Maltese: Analiżi primarja (MACE -3
English: The rates (events per patient-year of exposure) of severe hypoglycaemia (ISPAD definition; 0.51 vs 0.33), confirmed hypoglycaemia (57.71 vs 54.05) and nocturnal confirmed hypoglycaemia (6.03 vs 7.60) were comparable with Tresiba versus insulin detemir.
Maltese: Ir-rati ( avvenimenti għal kull sena ta' espożizzjoni ta' pazjent) ta' ipogliċemija severa (definizzjoni ISPAD ; 0.51 vs 0.33), ipogliċemija kkonfermata (57.71 vs 54.05) u ipogliċemija kkonfermata ta' billejl (6.03 vs 7.60) kienu simili meta tqabbel Tresiba ma' insulin detemir.
English: It delivers 1-80 units in steps of 1 unit.
Maltese: Tforni 1-80 unità f'żidiet ta' unità 1.
English: IDeg 0.6 units/kg
Maltese: 6U/kg
English: See your delivery system manual for further instructions.
Maltese: Ara l-manwal tas-sistema ta' forniment tiegħek għal istruzzjonijiet addizzjonali.
English: Detailed information on this medicinal product is available on the web site of the European Medicines Agency http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu/
English: 1 x 3 mL + 7 NovoFine needles 1 x 3 mL + 7 NovoTwist needles 5 x 3 mL
Maltese: 1 x 3 mL + 7 labar NovoFine 1 x 3 mL + 7 labar NovoTwist 5 x 3 ml
English: INFORMATION IN BRAILLE Tresiba cartridge 100
Maltese: INFORMAZZJONI BIL-BRAILLE Tresiba skartoċċ 100
English: 1 x 3 mL + 7 NovoFine needles 1 x 3 mL + 7 NovoTwist needles 2 x 3 mL
Maltese: 1 x 3 mL + 7 labar NovoFine 1 x 3 mL + 7 labar NovoTwist 2 x 3 mL
English: End of treatment FPG (mmol/L)
Maltese: FPG (mmol/L)
English: Pack sizes of 5 and 10 cartridges of 3 mL.
Maltese: Daqsijiet tal-pakketti ta' 5 u 10 skrataċ ta' 3 ml.
English: It delivers 2-160 units in steps of 2 units.
Maltese: Tforni 2-160 unità f'żidiet ta' 2 unitajiet.
English: The following substances may reduce the insulin requirement Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Maltese: Prodotti mediċinali kontra d-dijabete li jittieħdu mill-ħalq, agonisti ta' riċetturi GLP-1, inibituri ta' monoamine oxidase (MAOI), imblokkaturi tar-riċetturi beta, inibituri tal-enzima li tibdel angiotensin (ACE), salicylates, sterojdi anaboliċi u sulfonamides.
English: Ratio: 0.54 [0.21; 1.42]
Maltese: Proporzjon: 0.54 [0.21; 1.42]
English: No safety issues were identified with Tresiba with respect to adverse events and standard safety parameters.
Maltese: Ma ġew identifikati ebda kwistjonijiet ta' sigurtà b'Tresiba fir-rigward ta' avvenimenti avversi u parametri standard ta' sigurtà.
English: Elderly (≥65 years old)
Maltese: Anzjani (≥65 sena)
English: The ratio between AUCGIR,0-12h,SS and AUCGIR,τ,SS was 0.5.
Maltese: Il-proporzjon bejn l-AUCGIR,0-12h,SS u l
English: Confirmed4
Maltese: manteniment4
English: • sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma
Maltese: • simpatomimetiċi bħal epinephrine (adrenaline), salbutamol jew terbutaline,użati fil-kura tal ażżma