FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.
Maltese: Għalhekk, prodotti mediċinali li jiġu mmetabolizzati minn CYP1A2 (bħal duloxetin, alosetron, theophylline u tizanidine) għandhom jintużaw b'kawtela matul il-kura għax jista' jkun hemm tnaqqis fl-effikaċja ta' dawn il-prodotti.
English: PV-Poland@zentiva.com
Maltese: PV-Spain@zentiva.com
English: PV-Estonia@zentiva.com
Maltese: PV-Greece@zentiva.com
English: Tel: +34 931 815 250 PV-Spain@zentiva.com
Maltese: Tel: +40 021 317 31 36 PV-Romania@zentiva.com
English: For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
Maltese: Għal substrati oħrajn ta' BCRP (eż., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) u l-familja ta' OATP,
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.
Maltese: Id-doża irrakkomandata ta` manteniment hija leflunomideta' li għandha tinżamm wara, għall-artrite rewmatika, hija ta' bejn 10 mg u 20 mg darba kuljum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BLISTER PACK
Maltese: PAKKETT TA'BARRA/FOLJA
English: Tel: +353 766 803 944 PV-Ireland@zentiva.com
Maltese: Tlf: +47 219 66 203 PV-Norway@zentiva.com
English: Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia).
Maltese: Għalhekk, l-inċidenza totali ta' infezzjonijiet tista' tiżdied (partikolarment ir-rinite, il-bronkite u l-pulmonite).
English: PV-Romania@zentiva.com
Maltese: PV-Ireland@zentiva.com
English: • Physician Leaflet
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
Maltese: 30 pillola miksija b'rita 50 pillola miksija b'rita 100 pillola miksija b'rita
English: It is recommended that patients receiving leflunomide are not treated with colestyramine or activated powdered charcoal because this leads to a rapid and significant decrease in plasma A771726 (the active metabolite of leflunomide; see also section 5) concentration.
Maltese: Intwera li fil-bniedem it-teħid ta' suspenzjoni orali tat-trab ta' charcoal mediċinali attivat jew ta' colestyramine iwassal għal żieda mgħaġġla u sinifikanti fir-rata t'eliminazzjoni ta' A771726 u tnaqqis fil-livelli fil-plażma (ara sezzjoni 4.9).
English: Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4).
Maltese: Bħal sustanzi oħra li għandhom potenzjal immunosoppressiv, leflunomide jista' jżid is-suxxettibbiltà għall-infezzjonijiet, inklużi dawk opportunistiċi (ara wkoll sezzjoni 4.4).
English: A771726 plasma levels can be expected to be above 0.02 mg/L for a prolonged period.
Maltese: Żmien ta' stennija Il-livelli fil-plażma ta' A771726 huma mistennija li jkunu 'l fuq minn 0.02 mg/L għal żmien twil.
English: Rheumatoid arthritis
Maltese: Disturbi psikjatriċi
English: Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Maltese: Leflunomide ma kienx antiġeniku fi provi fuq l-annimali.
English: The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents including Tumour Necrosis Factor alpha-Inhibitors has not been adequately studied up to now in randomised trials (with the exception of methotrexate, see section 4.5).
Maltese: S'issa, l-użu ta` leflunomide flimkien mal-mediċini kontra l-malarja użati fir-rewmatiżmu, (e.g. chloroquine u hydroxychloroquine), deheb li jingħata sew fil-muskoli kif ukoll mill-ħalq, Dpenicillamine, azathioprine u sustanzi oħra li jrażżnu l-istat immuni inklużi l-inibituri alfa tal-Fattur ta' Nekrosi Tumurali, s'issa għadu ma ġiex studjat biżżejjed f'studji magħmulin b'mod arbitrarju (bleċċezzjoni ta' methotrexate, ara sezzjoni 4.5).
English: The initial period was followed by an open label maintenance period of three months, during which both groups received leflunomide 20 mg daily.
Maltese: manteniment open-label ta' tliet xhur li matulhom iż-żewġ gruppi rċevew 20 mg ta' leflunomide kuljum.
English: Elderly
Maltese: Treddigħ
English: PV-Norway@zentiva.com
Maltese: PV-Iceland@zentiva.com
English: Thereafter, the A771726 plasma concentration must be determined again after an interval of at least 14 days.
Maltese: A771726 fil-plażma jrid jerġa' jitkejjel wara perijodu ta' mhux anqas minn 14-il jum.
English: Omission of the loading dose may decrease the risk of adverse events (see section 5.1).
Maltese: Ir-riskju ta' avvenimenti avversi jista' jonqos jekk ma tintużax doża ta' kkargar (ara sezzjoni 5.1).
English: Doc.
Maltese: IU.
English: Ref.: EMEA/540887/2009 EMEA/H/C/1036
Maltese: EMEA/5408872009 EMEA/H/C/1036
English: It is available in pre-filled syringes containing between 1,000 and 30,000 international units (IU) of the active substance, epoetin theta.
Maltese: Dan jiġi f'siringi mimlijin għal-lest li fihom bejn 1,000 u 30,000 unità internazzjonali (IU) tas-sustanza attiva, epoetin theta.
English: This document is a summary of the European Public Assessment Report (EPAR).
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR).
English: Other information about Biopoin:
Maltese: Informazzjoni oħra dwar Biopoin:
English: The most common side effects with Biopoin (seen in between 1 and 10 patients in 100) are shunt thrombosis (clots that can form in blood vessels of patients on dialysis, a blood clearance technique), headache, hypertension (high blood pressure), hypertensive crisis (sudden, dangerously high blood pressure), skin reactions, arthralgia (joint pain) and influenza (flu)-like illness.
Maltese: L-aktar effetti sekondarji b'Biopoin (innotati f'bejn pazjent 1 u 10 minn 100) huma trombożi fix-xant (demm magħqud li jista' jifforma fil-vini tad-demm ta' pazjenti fuq dijaliżi, teknika ta' tneħħija ta' demm), uġigħ ta' ras, pressjoni għolja (pressjoni għolja fid-demm), kriżi ta' pressjoni għolja (pressjoni għolja fid-demm b'mod perikoluż, f'daqqa), reazzjonijiet fil-ġilda, artralġja (uġigħ fil-ġogi) u sindrome ta' influwenza (riħ).
English: This summary was last updated in 10-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2009.
English: In the cancer studies, between 64 and 73% of patients who received Biopoin had an increase in haemoglobin of 2 g/dl compared with between 20 and 26% of patients who were given placebo.
Maltese: Fl-istudji tal-kanċer, bejn 64 u 73% tal-pazjenti li rċevew Biopoin kellhom żieda fl-emoglobina ta' 2 g/dl meta mqabbla ma' bejn 20 u 26% tal-pazjenti li rċevew il-plaċebo.
English: Average weekly increases in haemoglobin were 0.73 and 0.58 g/dl in patients receiving the higher dose of Biopoin compared with 0.20 and 0.26 g/dl in patients receiving the lower dose of Biopoin.
Maltese: Iż-żidiet medji ta' kull ġimgħa fl-emoglobina kienu ta' 0.73 u 0.58 g/dl f'pazjenti li kienu qed jirċievu d-doża l-għolja ta' emoglobina meta mqabbla mal-0.20 u 0.26 g/dl f'pazjenti li kienu qed jirċievu d-doża aktar baxxa ta' Biopoin.
English: It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin theta.
Maltese: Dan huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': dan hu magħmul b'ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi li tipproduċi epoetin theta.
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Biopoin to CT Arzneimittel GmbH on 23 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida mal-Unjoni Ewropea kollha għal Biopoin lil CT Arzneimittel GmbH fit-23 ta' Ottubru 2009.
English: Erythropoietin is produced by the kidneys.
Maltese: Eritropojetin huwa prodott millkliewi.
English: Biopoin is used to treat anaemia (low levels of red blood cells or haemoglobin) that is causing symptoms.
Maltese: Biopoin jintu¿a biex jikkura l-anemija (livelli baxxi ta' ċelloli ħomor tad-demm jew emoglobina) li tkun qed tikkaw¿a s-sintomi.
English: Why has Biopoin been approved?
Maltese: Għaliex ġie approvat Biopoin?
English: There were four main studies in 842 chronic renal failure patients and three main studies in 586 nonmyeloid cancer patients receiving chemotherapy.
Maltese: Kien hemm erba' studji ewlenin fi 842 pazjent b'insuffiċjenza renali u tliet studji f'586 pazjenti b'kanċer mhux majelojde li kienu qed jirċievu l-kimoterapija.
English: What is Biopoin?
Maltese: X'inhu Biopoin?
English: The active substance in Biopoin, epoetin theta, is a copy of a human hormone called erythropoietin that stimulates the production of red blood cells from the bone marrow.
Maltese: Is-sustanza attiva f'Biopoin, epoetin theta, hija kopja tal-ormon uman imsejjaħ erythropoietin li jistimula l-produzzjoni taċ-ċelloli l-ħomor tad-demm mill-mudullun.
English: In the four renal failure studies, patients were given either Biopoin (under the skin or into a vein) or epoetin beta (another erythropoietin-like medicine used for anaemia).
Maltese: Fl-erba' studji tal-insuffiċjenza renali, il-pazjenti ngħataw jew Biopoin (taħt il-ġilda jew ġo vina) jew epoetin beta (mediċina oħra bħall-erythropoietin użata għall-anemija).
English: Biopoin is a solution for injection.
Maltese: Biopoin huwa soluzzjoni għall-injezzjoni.
English: What is the risk associated with Biopoin?
Maltese: X'inhu r-riskju assoċjat ma' Biopoin?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Biopoin's benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Biopoin huma akbar mir-riskji tiegħu għat-trattament tal-anemija sintomatika f'adulti b'insuffiċjenza renali kronika u f'adulti b'kanċers mhux majelojdi li jkunu qed jirċievu l-kimoterapija.
English: How has Biopoin been studied?
Maltese: Kif ġie studjat Biopoin?
English: It is used in adults with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) and in adults with non-myeloid cancer (cancer not originating in the bone marrow) who are receiving chemotherapy (medicines to treat cancer).
Maltese: Dan jintu¿a fl-adulti b'insuffiċjenza renali kronika (tnaqqis progressiv, għal perjodu ta' żmien twil, fl-abbiltà tal-kliewi li jaħdmu sewwa) u f'adulti b'kanċer mhux majelojde (kanċer li ma joriġinax fil-mudullun) li jkunu qed jirċievu l-kimoterapija (mediċini biex jikkuraw ilkanċer).
English: Because of the risk of high blood pressure, special care should be taken to monitor and control the patient's blood pressure to avoid complications such as a hypertensive crisis.
Maltese: Minħabba r-riskju ta' pressjoni għolja fid-demm, għandha tingħata attenzjoni speċjali biex il-pressjoni għolja tal-pazjent tiġi mmonitorjata u kkontrollata biex jiġu evitati kumplikazzjonijiet bħall-kriżi ta' pressjoni għolja.
English: For the full list of all side effects reported with Biopoin, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rappurtati b'Biopoin, ara lFuljett ta' Tagħrif.
English: The effects of Biopoin were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Biopoin għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: The main measure of effectiveness was the average change in haemoglobin levels from 15 to 26 weeks after treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla medja fil-livelli ta' emoglobina minn 15 għal 26 ġimgħa wara t-trattament.
English: In chronic renal failure patients, the correction phase showed that increasing the starting dose of Biopoin leads to improvements in haemoglobin levels.
Maltese: F'pazjenti b'insuffiċjenza renali kronika, fil-fażi ta' korrezzjoni, intwera li, li tiżdied id-doża inizjali ta' Biopoin twassal għal titjib fil-livelli tal-emoglobina.
English: Biopoin was effective at treating anaemia in patients with chronic renal failure and patients with nonmyeloid cancer who were receiving chemotherapy.
Maltese: Biopoin kien effettiv fil-kura tal-anemija f'pazjenti b'insuffiċjenza renali kronika u f'pazjenti b'kanċer mhux majelojdi li kienu qed jirċievu l-kimoterapija.
English: In the cancer studies, the main measure of effectiveness was the number of patients receiving either Biopoin or placebo (a dummy treatment) with an increase in haemoglobin of 2 g/dl over 12 or 16 weeks.
Maltese: Fl-istudji tal-kanċer, il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li rċevew jew Biopoin jew plaċebo (kura finta) b'żieda fl-emoglobina ta' 2 g/dl fuq 12 jew 16-il ġimgħa.
English: The epoetin theta in Biopoin works in the body in the same way as the natural hormone to stimulate red blood cell production.
Maltese: L-epoetin theta f'Biopoin taħdem fil-ġisem bl-istess mod tal-ormon naturali biex tistimula l-produzzjoni taċ-ċelloli l-ħomor tad-demm.
English: This dose may be doubled after four weeks if the haemoglobin has not increased by at least 1 g/dl and can, if needed, be increased further to 60,000 IU after four additional weeks.
Maltese: Din id-doża tista' tiġi rduppjata wara erba' ġimgħat jekk l-emoglobina ma tkunx żdiedet b'tal-inqas 1 g/dl, u jekk ikun hemm bżonn, tista' tiżdied aktar għal 60,000 IU wara erba' ġimgħat addizzjonali.
English: The weekly dose of Biopoin should not be more than 60,000 IU.
Maltese: Id-doża ta' Biopoin ta' kull ġimgħa m'għandhiex tkun aktar minn 60,000
English: Vistor hf.
Maltese: Vhutor hf.
English: Figure 1:
Maltese: Figura 1:
English: Linearity/non-linearity
Maltese: Linearità/nuqqas ta' linearità
English: P-glycoprotein (P-gp)
Maltese: P-glikoproteina (P-gp)
English: Based on a Log-rank test.
Maltese: Ibbażat fuq Log-rank test.
English: Renal function
Maltese: Funzjoni renali
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Soft capsule (capsule).
Maltese: Kapsula ratba (kapsula).
English: (listed in section 6).
Maltese: (imniżżla fis-sezzjoni 6).
English: Renal failure (see section 4.4)
Maltese: Insuffiċjenza renali (ara sezzjoni 4.4)
English: CI: confidence interval
Maltese: CI: intervall ta' fiduċja
English: The difference between the treatment groups reached nominal statistical significance (p=0.0136).
Maltese: Id-differenza bejn il-gruppi ta' kura laħqet sinifikat statistiku nominali (p=0.0136).
English: Date of latest renewal: 23 September 2019
Maltese: Data tal-aħħar tiġdid: 23 ta' Settembru 2019
English: Elderly patients (≥ 65 years)
Maltese: Pazjenti anzjani (≥ 65 sena)
English: In addition nintedanib inhibits Flt-3 (Fms-like tyrosine-protein kinase), Lck (lymphocyte-specific tyrosine-protein kinase), Lyn (tyrosine-protein kinase lyn) and Src (proto-oncogene tyrosine-protein kinase src) kinases.
Maltese: Barra minn hekk, nintedanib jinibixxi lFlt-3 (Fms-like tyrosine-protein kinase), Lck (lymphocyte-specific tyrosine-protein kinase), Lyn (tyrosine-protein kinase lyn) u Src (proto-oncogene tyrosine-protein kinase src) kinases.
English: Pruritus, Alopecia
Maltese: Ħakk, Alopeċja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 ta' Jannar 2015
English: BIBF 1202 is subsequently glucuronidated by uridine 5'-diphosphoglucuronosyltransferase enzymes (UGT) enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide.
Maltese: BIBF 1202 sussegwentement jiġi glukuronidat minn enzimi tal-uridine 5'-diphospho-glucuronosyltransferase (UGT), jiġifieri UGT 1A1, UGT 1A7, UGT 1A8, u UGT 1A10 għal BIBF 1202 glucuronide.
English: Similar results were observed in analyses using a conservative threshold of 10%.
Maltese: Riżultati simili kienu osservati fl-analiżi li użat livell limitu konservattiv ta' 10%.
English: p-value
Maltese: valur p
English: 60 x 1 soft capsules
Maltese: 60 x 1 kapsuli rotob
English: After intravenous infusion, a high volume of distribution (Vss: 1,050 L, 45.0% gCV) was observed.
Maltese: Wara infużjoni fil-vini, ġie osservat volum għoli ta' distribuzzjoni (Vss : 1,050 L, 45.0% gCV).
English: Gastrointestinal adverse events were frequent and in line with the established safety profile of each component.
Maltese: Avvenimenti avversi gastrointestinali kienu frekwenti u konformi mal-profil ta' sigurtà stabbilit ta' kull komponent.
English: Race
Maltese: Razza
English: 3 years
Maltese: 3 snin
English: Age
Maltese: Età
English: The absolute bioavailability of a 100 mg dose was 4.69% (90% CI: 3.615 - 6.078) in healthy volunteers.
Maltese: Ilbijodisponibilità assoluta ta' doża ta' 100 mg kienet ta' 4.69% (90% CI: 3.615 - 6.078) f'voluntiera b'saħħithom.
English: Nintedanib was shown to be not a substrate or inhibitor of OATP-1B1, OATP-1B3, OATP-2B1, OCT-2, or MRP-2 in vitro.
Maltese: Intwera li nintedanib mhuwiex substrat jew inibitur ta' OATP-1B1, OATP-1B3, OATP-2B1, OCT-2, jew MRP-2 in vitro.
English: BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT Lot
English: Capsule shell gelatin glycerol (85%) titanium dioxide (E171) iron oxide red (E172) iron oxide yellow (E172)
Maltese: Qoxra tal-kapsula gelatin glycerol (85%) titanium dioxide (E171) iron oxide red (E172) iron oxide yellow (E172)
English: PHARMACEUTICAL FORM AND CONTENTS 30 x 1 soft capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 x 1 kapsuli rotob
English: INFORMATION IN BRAILLE Ofev 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ofev 150 mg
English: Nintedanib is a substrate of P-gp (see section 5.2).
Maltese: Nintedanib hu substrat ta' P-gp (ara sezzjoni 5.2).
English: Capsule content triglycerides, medium-chain hard fat lecithin (soya) (E322)
Maltese: Kontenut tal-kapsula triglycerides, medium-chain xaħam iebes lecithin (soya) (E322)
English: LIST OF EXCIPIENTS Contains soya lecithin.
Maltese: TA' EĊĊIPJENTI Fih soya lecithin.
English: Myocardial infarction
Maltese: Infart mijokardijaku
English: Triglycerides, medium-chain, hard fat, soya lecithin (E322) (see section 2) Capsule shell: Gelatin, glycerol (85%), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
Maltese: Kontenut tal-kapsula: Triglycerides, medium-chain, hard fat, soya lecithin (E322) (ara sezzjoni 2) Qoxra tal-kapsula: Gelatin, glycerol (85%), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172) Linka tal-istampar:
English: C] nintedanib was via faecal/biliary excretion (93.4% of dose, 2.61% gCV).
Maltese: C] nintedanib kienet permezz ta' tneħħija mal-ippurgar/biljari (93.4% tad-doża, 2.61% gCV).
English: Nintedanib is a substrate of P-gp.
Maltese: Nintedanib huwa substrat ta' P-gp.
English: Arterial thromboembolic events
Maltese: Avvenimenti tromboemboliċi arterjali
English: In group 2, the adjusted geometric mean ratios (90% CI)) were 97% (86% - 110%) and 95% (86% - 106%) for Cmax,ss and AUCτ,ss of pirfenidone, respectively (n=12 for intraindividual comparison).
Maltese: Fi grupp 2, il-proporzjonijiet ġeometriċi medji aġġustati (CI ta' 90%) kienu 97% (86%-110%) u 95% (86%-106%) għal Cmax, ss u AUCτ,ss ta' pirfenidone, rispettivament (n=12 għal paragun intraindividwali).
English: Cytochrome (CYP)-enzymes
Maltese: Enzimi ta' ċitokrom (CYP)
English: Gastrointestinal perforations
Maltese: Perforazzjonijiet gastrointestinali
English: Exposure to nintedanib increased linearly with age.
Maltese: L-esponiment għal nintedanib żdied b'mod lineari mal-età.
English: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%).
Maltese: Nintedanib jiġi eliminat b'mod predominanti permezz ta' tneħħija mill-bila/ippurgar (> 90%).
English: Based on data collected up to 372 days (52 weeks + 7 day margin).
Maltese: Ibbażat fuq dejta miġbura sa 372 ġurnata (52 ġimgħa + marġini ta' 7 ijiem).
English: Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF.
Maltese: Nintedanib ġie studjat fi provi kliniċi ta' 1,529 pazjent li jsofru minn IPF.
English: Frequency categories are defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenzi kienu ddefiniti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Each 100 mg soft capsule contains 1.2 mg of soya lecithin.
Maltese: Kull kapsula ratba ta' 100 mg fiha 1.2 mg ta' soya lecithin.
English: See leaflet for further information.
Maltese: Ara l-fuljett għal aktar informazzjoni.
English: The results of all survival endpoints (such as on-treatment mortality and respiratory mortality) showed a consistent numerical difference in favour of nintedanib.
Maltese: Ir-riżultati tal-punti aħħarin ta' sopravivenza kollha (bħall-mortalità matul il-kura u l-mortalità respiratorja) urew differenza numerika konsistenti favur nintedanib.
English: Ofev 150 mg soft capsules EU/1/14/979/003
Maltese: Ofev 150 mg kapsuli rotob EU/1/14/979/003
English: Total plasma clearance after intravenous infusion was high (CL: 1,390 mL/min, 28.8% gCV).
Maltese: It-tneħħija totali mill-plażma wara infużjoni ġol-vini kienet għolja (CL: 1,390 mL/min, 28.8% gCV).
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta' reazzjonijiet avversi
English: Ofev 100 mg soft capsules EU/1/14/979/001
Maltese: Ofev 100 mg kapsuli rotob EU/1/14/979/001
English: Vomiting led to discontinuation in 0.8% of the patients.
Maltese: Irrimettar wassal għal twaqqif f'0.8% tal-pazjenti.
English: Diarrhoea, nausea and vomiting were the most frequent adverse events reported in 20 (37.7%) versus 16 (31.4%), in 22 (41.5%) versus 6 (11.8%) and in 15 (28.3%) versus 6 (11.8%) patients, treated with pirfenidone added to nintedanib versus nintedanib alone, respectively.
Maltese: Dijarea, dardir u rimettar kienu l-aktar avvenimenti avversi frekwenti rrappurtati f'20 (37.7%) kontra 16 (31.4%), fi 22 (41.5%) kontra 6 (11.8%) u fi 15 (28.3%) kontra 6 (11.8%) pazjenti, ittrattati b'pirfenidone miżjud ma' nintedanib kontra nintedanib waħdu, rispettivament.
English: Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B; see section 5.2).
Maltese: L-esponiment żdied f'pazjenti b'indeboliment tal-fwied (Child Pugh A, Child Pugh B; ara sezzjoni 5.2).
English: Each 150 mg soft capsule contains 1.8 mg of soya lecithin.
Maltese: Kull kapsula ratba ta' 150 mg fiha 1.8 mg ta' soya lecithin.
English: The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC).
Maltese: Il-punt aħħari primarju kien ir-rata annwali ta' tnaqqis fil-Kapaċità Vitali Furzata (FVC).
English: D-55216 Ingelheim am Rhein Germany
Maltese: D-55216 Ingelheim am Rhein Il-Ġermanja
English: What Ofev contains - The active substance is nintedanib.
Maltese: X'fih Ofev - Is-sustanza attiva hi nintedanib.