FrancophonIA/ELRC3.0 huggingface dataset:
English: Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity.
Maltese: Axitinib seta' jiġi interrott jew imnaqqas għal 3 mg darbtejn kuljum u sussegwentement għal 2 mg darbtejn kuljum biex tiġi mmaniġġjata t-tossiċità.
English: Median in months (95% CI)
Maltese: (CI ta' 95%)
English: • Hoarseness, cough, shortness of breath
Maltese: • Ħanqa, sogħla, qtugħ ta' nifs
English: Infusion related reaction
Maltese: Reazzjonijiet relatati mal-infużjoni
English: • you receive medicines to suppress your immune system;
Maltese: • tirċievi mediċini biex trażżan is-sistema immuni tiegħek;
English: All 21 patients with immune-related pneumonitis were treated with corticosteroids and 17 (81%) of the 21 patients were treated with high-dose corticosteroids for a median of 8 days (range: 1 day to
Maltese: Il21 pazjent kollha b'pulmonite relatata mal-immunità kienu ttrattati b'kortikosterojdi u 17 (81%) mill
English: Hypothyroidism should be managed with replacement therapy and hyperthyroidism with anti-thyroid medicinal product, as needed.
Maltese: Ipotirojdiżmu għandu jiġi mmaniġġjat permezz ta' terapija ta' sostituzzjoni u ipertirojdiżmu permezz ta' prodott mediċinali kontra t-tirojde, kif meħtieġ.
English: Immune-related nephritis and renal dysfunction In patients treated with avelumab as monotherapy, immune-related nephritis occurred in 0.1% (1/1,738) of patients receiving avelumab leading to permanent discontinuation of avelumab.
Maltese: Nefrite relatata mal-immunità u disfunzjoni tal-kliewi F'pazjenti ttrattati b'avelumab bħala monoterapija, nefrite relatata mal-immunità li wasslet għal twaqqif permanenti ta' avelumab seħħet f'0.1% (1/1,738) tal-pazjenti li rċevew avelumab.
English: Immune-related pneumonitis
Maltese: Pulmonite relatata mal-immunità
English: If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered.
Maltese: Jekk ikunu persistenti (għal aktar minn 5 ijiem), għandha tiġi kkunsidrata terapija ta' kortikosterojdi bi prednisone jew ekwivalenti segwita minn tnaqqis bil-mod għax-xejn.
English: The median time to onset of Type 1 diabetes mellitus was 1.9 months (range: 1.1 months to 7.3 months).
Maltese: Iż-żmien medjan għall-bidu ta' dijabete mellitus tat-Tip 1 kien ta' 1.9 xhur (medda: 1.1 xhur sa 7.3 xhur).
English: Do not stop treatment with Bavencio unless you have discussed this with your doctor.
Maltese: Twaqqafx it-trattament b'Bavencio sakemm ma tkunx iddiskutejt dan mat-tabib tiegħek.
English: In patients treated with avelumab in combination with axitinib, Grades 3 and Grade 4 increased ALT and increased AST were reported in 9% and 7% of patients, respectively.
Maltese: F'pazjenti ttrattati b'avelumab flimkien ma' axitinib, żieda fl-ALT u żieda fl-AST għal Grad 3 u Grad 4 kienu rrappurtati f'9% u f'7% tal-pazjenti, rispettivament.
English: Arthralgia, back pain, myalgia
Maltese: Artralġja, uġigħ fid-dahar, uġigħ fil-muskoli
English: Steady-state exposure was approximately uniform over a wide range of body weights (30 to 204 kg) for body weight normalised dosing.
Maltese: L-esponiment fl-istat fiss kien bejn wieħed u ieħor l-istess fuq medda wiesgħa ta' piżijiet tal-ġisem (30 sa 204 kg) għal dożaġġ normalizzat għallpiż tal-ġisem.
English: This is very common for thyroid gland, common for adrenal glands, and uncommon for pituitary gland.
Maltese: Dan iseħħ bi frekwenza komuni ħafna għall-glandola tat-tirojde, komuni għall-glandoli adrenali, u mhux komuni għall glandola pitwitarja.
English: For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Maltese: o Nefrite relatata mal-immunità u disfunzjoni tal-kliewi o Reazzjonijiet avversi oħra relatati mal-immunità inkluża mijosite, ipopitwitariżmu,
English: Grade 4 colitis or diarrhoea or recurrent Grade 3 colitis
Maltese: Kolite jew dijarea ta' Grad 4 jew kolite rikorrenti ta' Grad 3
English: Invented name Strength
Maltese: Numru tal-EU Isem inventat
English: Pharmaceutical Form Route of administration Packaging
Maltese: Għamla farmaëewtika
English: System (CNS)1
Maltese: Ċentrali (CNS)1
English: Intra-abdominal
Maltese: Intra-abdominali
English: Retroperitoneal
Maltese: Retroperitoneali
English: Lonza Biologicals Inc. 101 International Drive Portsmouth
Maltese: 101 International Drive Portsmouth
English: Central Nervous
Maltese: Sistema Nervuża
English: Pharmacodynamic Effects
Maltese: Effetti farmakodinamiċi
English: Immunogenicity
Maltese: L-Immunoġeniċità
English: Placebo rates in PROWESS 0.4% vs 1.2% respectively).
Maltese: Ir-rati ta' plaċebo fi PROWESS 0.4% kontra 1.2% rispettivament)
English: Lilly Pharma Fertigung und Distribution GmbH & Co. KG Teichweg 3
Maltese: Lilly Pharma Fertigung und Distribution GmbH & Co.
English: Eli Lilly Polska Sp. z o.o.
Maltese: Eli Lilly Polska Sp. z o.o. Tel.:
English: PROWESS Follow-up Study
Maltese: PROWESS Studju Sussegwenti
English: For a full list of excipients, see 6.1.
Maltese: Għal lista kompleta ta' sustanzi mhux attivi, ara Sezzjoni 6.1.
English: • Active internal bleeding
Maltese: • Fsada interna u attiva
English: Belgique/België/Belgien Eli Lilly Benelux S.A./N.V.
Maltese: Belgique/België/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2002.
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 22 ta' Awissu 2002
English: • Recent administration (within 7 days) of oral anticoagulants
Maltese: • L-għoti reċenti (sa 7 ijiem) ta' antikoagulanti orali
English: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Maltese: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, L-Olanda
English: • Concurrent heparin therapy ≥ 15 International Units/kg/hr
Maltese: • Terapija bl-eparina fl-istess żmien ≥ 15-il Unità Internazzjonali/kg/siegħa
English: There was also no difference in 28-day mortality (17.1% versus 17.3% in the Xigris and placebo groups, respectively).
Maltese: Lanqas ma kien hemm differenza fil-mortalità fuq 28 ġurnata (17.1% kontra 17.3% filgruppi Xigris u plaċebo, rispettivament).
English: EU/1/02/225/002
Maltese: FIS-SUQ EU/1/02/225/002
English: EU/1/02/225/001
Maltese: FIS-SUQ EU/1/02/225/001
English: Caution should be employed when Xigris is used with other drugs that affect haemostasis (see sections 4.3 and 4.4) including Protein C, thrombolytics (e.g. streptokinase, tPA, rPA and urokinase), oral anticoagulants (e.g. warfarin), hirudins, antithrombin, aspirin and other anti platelets agents, e.g. nonsteroidal anti-inflammatory drugs, ticlopidine and clopidogrel, glycoprotein IIb/IIIa antagonists (such as abciximab, eptifibatide, tirofiban) and prostacyclins such as iloprost.
Maltese: Wieħed għandu joqgħod attent meta Xigris jintuża ma' mediċini oħra li jeffettwaw l-emostażi (ara sezzjonijiet 4.3 u 4.4) fosthom il-Proteina Ċ, trombolitiċi (eż. streptokinase, tPA, rPA u urokinase), antikoagulanti orali (eż. warfarin), hirudins, antithrombin, aspirina u sustanzi oħra li għandhom effett kontra l-plejtlets, eż. mediċini kontra l-infjammazzjoni li mhumiex sterojdi, ticlopidine, u clopidogrel, antagonisti tal-glikoproteini IIb/IIIa (bħal abciximab, eptifibatide, tirofiban) u prostaċiklini bħal iloprost.
English: Intra-thoracic
Maltese: Intra-toraċiku
English: Placebo [PROWESS] N=840
Maltese: Post ta' l-emorraġija [PROWESS] N=850 [PROWESS] N=840 [ENHANCE] N=2378 Gastrointestinali
English: Activated Protein C is a crucial coagulation regulator.
Maltese: IlProteina Ċ attivata hija regulatur kruċjali tal-koagulazzjoni.
English: Pharmacotherapeutic group: antithrombotic agents, enzymes, ATC code: B01AD10
Maltese: Kategorija farmakoterapewtika: sustanzi antitrombotiċi, enżimi, Kodiċi ATC:
English: • Platelet count < 30,000 x 106/l, even if the platelet count is increased after transfusions
Maltese: • Għadd tal-plejtlets < 30,000 x 106/1, ukoll jekk l-għadd tal-plejtlets jiżdied wara t-trasfużjonijiet
English: Plasma drotrecogin alfa (activated) steady-state concentrations are proportional to the infusion rate over a range of infusion rates from 12 μg/kg/hr to 48 μg/kg/hr.
Maltese: Il-konċentrazzjonijiet fi stat stabbli ta' drotrecogin alfa (attivat) fil-plażma huma proporzjonali għar-rata ta' infużjoni fi skala ta' rati ta' infużjoni minn 12 μg/kg/siegħa sa 48 μg/kg/siegħa.
English: • Recent administration (within 3 days) of thrombolytic therapy
Maltese: • L-għoti reċenti (sa 3 ijiem) ta' terapija trombolitika
English: In the subgroup of patients with an APACHE II score ≥25 at baseline, the mortality was 31% in the Xigris group (128 out of 414) and 44% in the placebo group (176 out of 403).
Maltese: Fis-sottogrupp ta' pazjenti b'marka bażi ta' APACHE II >25, il-mortalità kienet ta' 31% fil-grupp Xigris (128 minn 414) u ta' 44% fil-grupp talplaċebo (176 minn 403).
English: Survival status was assessed in a follow-up study of PROWESS survivors.
Maltese: L-istatus tas-sopravvivenza kien analizzat fi studju sussegwenti fuq is-sopravviventi ta' PROWESS.
English: Genitourinary
Maltese: Ġenitourinarju
English: Prophylactic heparin did not increase the risk of serious bleeding compared to placebo (3.9% vs 5.2%, respectively), including CNS bleeding (1.0% vs 0.7%, respectively).
Maltese: Eparina mgħotija bħala profilassi ma żiedetx ir-riskju ta' fsada serja meta mqabbla ma' plaċebo (3.9% kontra 5.2%, rispettivament), inkluż il-fsada fis-CNS (1.0% kontra 0.7%,rispettivament)
English: EXP {MM/YYYY}
Maltese: JIS {XX/SSSS}
English: However prophylactic heparin increased the risk of non-serious bleeding compared with placebo (8.7% vs 5.7%, respectively; p= 0.0116).
Maltese: Madankollu eparina mgħotija bħala profilassi żiedet ir-riskju ta' dik il-fsada li m'hijiex serja meta mqabbla ma' plaċebo (8.7% kontra 5.7%,rispettivament; p=0.0116)
English: In the phase 1 studies, adverse events with a frequency of ≥ 5% included headache (30.9%), ecchymosis (23.0%), and pain (5.8%).
Maltese: Fl-istudji ta' Fażi 1, il-każijiet avversi bi frekwenza ta' ≥ 5% jiġbru fihom l-uġigħ ta' ras (30.9%), lekkimożi (23.0%), u l-uġigħ (5.8%).
English: The risk of CNS bleeding may increase with severe coagulopathy and severe thrombocytopenia (see sections 4.3 and 4.4).
Maltese: Ir-risk ta' fsada fis-ĊNS jista' jiżdied jekk ikun hemm koagulopatija gravi u tromboċitopenija gravi (ara Sezzjonijiet 4.3 u 4.4).
English: STORING XIGRIS
Maltese: X'fih Xigris:
English: In a randomised study of heparin versus placebo (XPRESS) in 1935 adult severe sepsis patients, all treated with drotrecogin alfa (activated), prophylactic heparin did not adversely affect mortality (heparin 28.3% versus placebo 31.9% in the overall ITT population, and heparin 30.3% versus placebo 26.9% in patients with multiple organ dysfunction treated within 24 hours of their first sepsis-induced organ dysfunction (n=890)).
Maltese: Fi studju kliniku ta' eparina kontra plaċebo (XPRESS) magħmul b'mod arbitrarju fuq 1935 pazjent adult b'sepsis gravi, kollha kkurati b'drotrecogin alfa (attivat), eparina mgħotija bħala profilassi m'affettwatx b'mod negattiv il-mortalità ( eparina 28.3% kontra plaċebo 31.9% filpopolazzjoni ITT kollha u eparina 30.3% kontra plaċebo 26.9% f'pazjenti b'disfunzjoni ta' organi multipli kkurati fi żmien 24 siegħa mill-ewwel disfunzjoni ta' organu tagħhom ikkawżat mis-sepsis (n=890).
English: A Phase 3b international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (ADDRESS) of adult severe sepsis patients at low risk of death, involved 1317 drotrecogin alfa (activated)-treated and 1293 placebo-treated patients.
Maltese: Fl-istudju kliniku Fażi 3b, internazzjonali, multiċentriku, magħmul b'mod arbitrarju, double-blind u kkontrollat bi plaċebo (ADDRESS) ta' pazjenti adulti b'sepsis gravi b'riskju żgħir ta' mewt, ħadu sehem 1,317-il pazjent li ħadu drotrecogin alfa (attivat) u 1,293 li ħadu l-plaċebo.
English: Xigris is very similar to a protein that occurs naturally in your blood.
Maltese: Xigris huwa simili ħafna għal proteina li tinsab naturali f'demmek.
English: Xigris is contraindicated in children below the age of 18 (see section 4.3 and 5.1).
Maltese: Xigris huwa kontra-indikat fit-tfal taħt it-18-il sena (ara sezzjonijiet 4.3 u 5.1).
English: The Phase 3 international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (PROWESS) involved 850 drotrecogin alfa (activated)-treated and 840 placebo-treated patients.
Maltese: Fl-istudju kliniku Fażi 3 internazzjonali, multiċentriku, magħmul b'mod arbitrarju,double-blind, ikkontrollat bi plaċebo (PROWESS) ħadu sehem 850 pazjent li ħadu drotrecogin alfa (attivat) u 840 li ħadu l-plaċebo.
English: Xigris is used to treat adults with severe sepsis.
Maltese: Xigris jintuża għall-kura ta' adulti b'sepsis serja.
English: Xigris is a recombinant version of the natural plasma-derived activated Protein C, from which it differs only by unique oligosaccharides in the carbohydrate portion of the molecule.
Maltese: Xigris huwa verżjoni rikombinanti tal-Proteina Ċ attivata derivata mill-plażma b'mod naturali, u huwa differenti minnha biss minħabba l-oligosakkaridi uniċi fil-porzjoni tal-karboidrati tal-molekula.
English: Patients were given a 96-hour constant rate infusion of Xigris at 24 μg/kg/hr (n=850) or placebo (n=840).
Maltese: Il-pazjenti ngħataw infużjoni ta' 24 μg/kg/siegħa ta' Xigris b'rata kostanti għal 96 siegħa (n=850) jew plaċebo (n=840).
English: Xigris was studied in one Phase 3 international, multi-centre, randomised, double-blind, placebocontrolled trial (PROWESS) in 1690 patients with severe sepsis.
Maltese: Xigris kien studjat f'studju wieħed Fażi 3 internazzjonali,magħmul b'mod arbitrarju, doubleblind,multiċentriku, ikkontrollat bi plaċebo (PROWESS) f'1,690 pazjent b'sepsis gravi.
English: Drotrecogin alfa (activated) is contraindicated in children below the age of 18 (see section 5.1).
Maltese: Drotecogin alfa (attivat) huwa kontra-indikat fit-tfal taħt it-18-il sena (ara sezzjoni 5.1).
English: During the infusion period in PROWESS and ENHANCE the incidence of serious bleeding events with Xigris was numerically higher in patients with recent [within 30 days] surgery than in patients without surgery (PROWESS: 3.3% vs 2.0%; ENHANCE: 5.0% vs 3.1% respectively.
Maltese: Waqt il-perijodu ta' infużjoni fi PROWESS u ENHANCE, l-inċidenza ta' każijiet serji ta' fsada bi Xigris kienet numerikament ogħla f'pazjenti li kellhom kirurġija reċenti [fi żmien 30 ġurnata] milli f'pazjenti li ma kellhom ebda kirurġija (PROWESS: 3.3% kontra 2.0%,ENHANCE: 5.0% kontra 3.1% rispettivament.
English: Xigris is contraindicated in children below the age of 18 years (see also sections 4.2 and 4.3).
Maltese: Xigris huwa kontra-indikat fit-tfal taħt it-18-il sena (ara sezzjonijiet 4.2 u 4.3).
English: Patients meeting the clinical diagnosis of severe sepsis had a) known or suspected infection, b) clinical evidence of systemic response to infection including fever or hypothermia, leucopenia or leucocytosis, tachycardia and tachypnoea, and c) acute organ dysfunction.
Maltese: Il-pazjenti li kkwalifikaw għad-dijanjożi klinika ta' sepsis gravi kellhom a) infezzjoni magħrufa jew suspettata, b) evidenza klinika ta' rispons sistemiku għall-infezzjoni inkluż deni jew ipotermja, lewkopenija jew lewkoċitożi, takikardija u takipnea, u c) nuqqas akut fil-funzjoni ta' l-organi.
English: Additionally there was no increased risk of serious bleeding, including central nervous system (CNS) bleeding.
Maltese: Barra minn hekk ma kien hemm ebda żieda fir-riskju ta' fsada serja, li tinkludi fsada fis-sistema nervuża ċentrali (CNS).
English: The percentage of patients experiencing at least one bleeding event in the two treatment groups was 24.9% and 17.7%, respectively.
Maltese: Il-perċentwal ta' pazjenti li għaddew minn għallinqas każ wieħed ta' fsada fiż-żewġ gruppi kien ta' 24.9% u 17.7% rispettivament.
English: Over the infusion period (study days 0-6) the number of patients experiencing CNS bleeding was 5 versus 1 (2.1% versus 0.4%) for the overall population (drotrecogin alfa (activated) versus placebo), with 4 of the 5 events in the drotrecogin alfa (activated) group occurring in patients ≤ 60 days old or ≤ 3.5 kg bodyweight.
Maltese: Waqt il-perjodu ta' l-infużjoni (ġranet ta' studju 0-6) l-għadd ta' pazjenti li kellhom fsada fis-CNS kien ta' 5 kontra 1 (2.1% kontra 0.4%) għall-popolazzjoni totali (drotrecogin alfa (attivat) kontra plaċebo), b'4 mill-5 każi fil-grupp drotrecogin alfa (attivat) ikunu ta' pazjenti ta' ≤ 60 ġurnata jew b'piż ≤ minn 3.5kg.
English: Not relevant.
Maltese: Mhux relevanti
English: The incidence of serious bleeding events during infusion (defined as study Day 0 through study Day 6) was 31 (2.4%) and 15 (1.2%) in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively (p=0.02).
Maltese: L-inċidenza ta' każijiet ta' fsada serja waqt linfużjoni (definita bħala Ġurnata ta' Studju 0 sa Ġurnata ta' Studju 6) kienet ta' 31 (2.4%) u ta' 15 (1.2%) fil-pazjenti li ħadu drotrecogin alfa (attivat) u l-plaċebo, rispettivament (p=0.02).
English: Severe sepsis is defined as sepsis associated with acute organ dysfunction.
Maltese: Is-sepsis gravi hija definita bħala sepsis assoċjata ma' nuqqas akut fil-funzjoni ta' l-organi.
English: Data from a placebo-controlled clinical trial (RESOLVE) did not establish efficacy of Xigris in paediatric patients suffering from severe sepsis, acute infection, systemic inflammation and respiratory and cardiovascular organ dysfunction.
Maltese: L-informazzjoni minn studju kliniku kkontrollat bil-plaċebo (RESOLVE)) ma wrietx li Xigris huwa effikaċi fil-kura ta' tfal li jbatu b'sepsis gravi, infezzjoni akuta, infjammazzjoni sistematika u nuqqas ta' funzjoni ta' l-organi respiratorji u kardjovaskulari.
English: The percentage of patients experiencing at least one bleeding event in the two treatment groups was 10.9% and 6.4%, respectively (p<0.001).
Maltese: 9% u 6.4% rispettivament (p<0.001).
English: At 28 days, the overall mortality rates were 24.7% for the Xigris-treated group and 30.8% for the placebo-treated group (p=0.005).
Maltese: Mat-28 jum, ir-rata ta' mortalità ġenerali kienet ta' 24.7% għall-grupp li ħa Xigris u ta' 30.8% għall-grupp li ħa l-plaċebo (p=0.005).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sucrose,
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: Hypersensitivity to the active substance, to any of the excipients or to bovine thrombin (a trace residue from the manufacturing process).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi jew għal trombin bovina (traċċa ta' residwu mill-proċess tal-manifattura).
English: In a Phase 3b international, single-arm, open-label clinical trial (ENHANCE), 2378 adult patients with severe sepsis received drotrecogin alfa (activated).
Maltese: F'studju kliniku Fażi 3b internazzjonali, b'fergħa waħda, double-blind (ENHANCE), 2,378 pazjent adult b'sepsis gravi ħadu drotrecogin alfa (attivat).
English: Xigris caused a more rapid decline in thrombotic markers such as D-dimer, prothrombin F1.2, and thrombin-antithrombin levels and a more rapid increase in Protein C and antithrombin levels.
Maltese: F1.2, u livelli ta' trombina-antitrombina u żieda aktar mgħaġġla fil-livelli tal-Proteina Ċ u l-antitrombina.
English: Following the completion of an infusion, the decline in plasma drotrecogin alfa (activated) concentrations is biphasic and is comprised of a rapid initial phase (t1/2 α=13 minutes) and a slower second phase (t1/2 β=1.6 hours).
Maltese: Wara tmiem linfużjoni, it-tnaqqis tal-konċentrazzjonijiet ta' drotrecogin alfa (attivat) fil-plażma jsir f'żewġ fażijiet u jikkonsisti f'fażi inizjali rapida (t1/2 α=13-il minuta) u t-tieni fażi aktar bil-mod (t1/2 β=1.6 sigħat).
English: In-hospital and 3 month survival status was reported for 98% and 94% of the 1690 PROWESS subjects respectively.
Maltese: L-istatus tas-sopravvivenza fl-isptar u għat-3 xhur ta' wara kien ta' 98% u ta' 94% ta' l-1,690 pazjent ta' PROWESS rispettivament.
English: • Patients with intracranial pathology; neoplasm or evidence of cerebral herniation
Maltese: • Pazjenti b'patoloġija intrakranika; neoplażma jew evidenza ta' ernja ċerebrali
English: A total of 2378 adult patients with severe sepsis received drotrecogin alfa (activated) in a Phase 3b, international, single-arm, open-label clinical trial (ENHANCE).
Maltese: Għadd ta' 2,378 pazjent adult b'sepsis gravi ħadu drotrecogin alfa (attivat) fl-istudju kliniku Fażi 3b, internazzjonali, f'fergħa waħda, fil-miftuħ (ENHANCE).
English: Xigris also restored endogenous fibrinolytic potential, as evidenced by a more rapid trend toward normalisation in plasminogen levels and a more rapid decline in plasminogen activator inhibitor-1 levels.
Maltese: Xigris radd lura wkoll il-potenzjal fibrinolitiku endoġenu, kif jidher minn tendenza aktar mgħaġġla lejn in-normalizzazzjoni fil-livelli tal-plażminoġen u tnaqqis aktar mgħaġġel fil-livelli ta' l-inibitur-1 ta' l-attivatur tal-plażminoġen.
English: The short half-life of 13 minutes accounts for approximately 80% of the area under the plasma concentration curve and governs the initial rapid accrual of plasma drotrecogin alfa (activated) concentrations towards the steady-state.
Maltese: Il-half life qasira ta' 13-il minuta tgħodd għal madwar 80% ta' l-erja taħt il-kurva tal-konċentrazzjoni talplażma u tirregola ż-żieda rapida inizjali tal-konċentrazzjonijiet ta' drotrecogin alfa (attivat) fil-plażma lejn stat stabbli.
English: Manufacturer: Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Teichweg 3, D- 35396 Giessen, Germany.
Maltese: KG, Teichweg 3, D- 35396 Giessen, Il-Ġermanja.
English: Skin/soft tissue
Maltese: Ġilda/tessut artab
English: The recommended dose of Xigris is 24 micrograms (μg) per kilogram (kg) of body weight each hour for 96 hours.
Maltese: Id-doża rrakkomandata ta' Xigris hija 24 mikrogrammi (µg) kull kilogramm (kg) tal-piż tal-ġisem kull siegħa għal 96 siegħa.
English: Recent surgery (within 30 days prior to study entry) was associated with a numerically higher risk of serious bleeding during infusion in both the Xigris-treated and the placebo-treated patients (Xigris: 3.6% in patients with recent surgery versus 1.6% in patients without recent surgery; placebo: 1.6% versus 0.9% respectively).
Maltese: Kirurġija reċenti (sa 30 ġurnata qabel beda l-istudju) kienet assoċjata ma' għadd ogħla ta' riskju ta' fsada serja waqt linfużjoni, kemm fil-pazjenti li ħadu Xigris kif ukoll f'dawk li ħadu l-plaċebo (Xigris: 3.6% fil-pazjenti li kellhom kirurġija reċenti kontra 1.6% fil-pazjenti li ma kellhomx kirurġija reċenti; plaċebo: 1.6% kontra 0.9% rispettivament).
English: This means that for scientific reasons it has been impossible to get complete information on this medicine.
Maltese: Dan ifisser li għal raġunijiet xjentifiċi kien impossibbli li tinkiseb informazzjoni kompleta dwar din il-mediċina.
English: Drotrecogin alfa (activated) and endogenous human Activated Protein C are inactivated in plasma by endogenous protease inhibitors but the mechanism by which they are cleared from plasma is unknown.
Maltese: Drotrecogin alfa (attivat) u l-Proteina Ċ Attivata umana endoġena huma inattivati fil-plażma blinibituri endoġeni tal-proteażi iżda l-mekkaniżmu li bih jitneħħew mill-plażma mhuwiex magħruf.
English: (The APACHE II score is designed to assess the risk of mortality based on acute physiology and chronic health evaluation).
Maltese: (Il-marka ta' APACHE II hija maħsuba li tkejjel ir-riskju tal-mortalità a bażi ta' levalwazzjoni tal-fiżjoloġija akuta u tas-saħħa kronika).
English: Date of latest renewal:
Maltese: Data ta' l-aħħar tiġdid:
English: Add the reconstituted drotrecogin alfa (activated) into a prepared infusion bag of sterile 0.9% Sodium Chloride Injection.
Maltese: Żid d-drotrecogin alfa (attivat) rikostitwit f'borża ta' infużjoni ppreparata b' 0.9% sodium chloride sterili.