FrancophonIA/ELRC3.0 huggingface dataset:
English: Withdraw 30 mL from the infusion bag with a syringe and discard the liquid.
Maltese: Iġbed 30 mL mill-borża tal-infużjoni b'siringa u armi l-likwidu.
English: • If you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
Maltese: • Jekk inti allerġiku/a għall-heparin jew heparins oħra b'piż molekulari baxx bħal nadroparin, tinzaparin jew dalteparin.
English: • The maximum amount of Thorinane given for the first two injections is 7,500 IU (75 mg).
Maltese: • L-ammont massimu ta' Thorinanemogħti għall-ewwel żewġ injezzjonijiet jkun 7,500 UI (75 mg).
English: o Initial 3,000 IU (30 mg) bolus
Maltese: o Injezzjoni tal-bidu ta' 3,000 UI (30 mg) f'daqqa
English: The rates of venous thromboembolism at the end of the double-blind phase were 12.0 % (n=20) in the placebo group and 4.8% (n=8) in the enoxaparin sodium group; p=0.02.
Maltese: Ir-rati ta' tromboemboliżmu fil-vini fl-aħħar tal-fażi fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża kienu 12.0 % (n=20) fil-grupp tal-plaċebo u 4.8% (n=8) fil-grupp ta' enoxaparin sodium; p=0.02.
English: Absorption The absolute bioavailability of enoxaparin sodium after SC injection, based on anti-Xa activity, is close to
Maltese: Il-bijodisponibbiltà assoluta ta' enoxaparin sodium wara injezzjoni SC, ibbażata fuq l-attività anti-Xa, hija qrib il-100%.
English: Prophylaxis of venous thromboembolic disease in medical patients with an acute illness expected to induce limitation of mobility
Maltese: Profilassi ta' mard tromboemboliku fil-vini f'pazjenti li jeħtieġu kura medika b'mard akut li mistenni jikkaġuna limitazzjoni fil-mobilità
English: However, since renal function is known to decline with age, elderly patients may show reduced elimination of enoxaparin sodium (see sections 4.2 and 4.4).
Maltese: Madankollu, minħabba li l-funzjoni tal-kliewi hija magħrufa li tonqos ma' avvanz fl-età, pazjenti anzjani jista' jkollhom eliminazzjoni ta' enoxaparin sodium mnaqqsa (ara sezzjonijiet 4.2 u 4.4).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: All patients were also treated with acetylsalicylic acid for a minimum of 30 days.
Maltese: Il-pazjenti kollha ġew ittrattati wkoll b'acetylsalicylic acid għal minimu ta' 30 jum.
English: 1 x 3,000 IU (30 mg) IV bolus plus 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours
Maltese: Doża 1 x 3,000 UI (30 mg) f'daqqa IV flimkien ma' 100 UI/kg (1 mg/kg) ta' piż tal-ġisem SC u imbagħad 100 UI/kg (1 mg/kg) ta' piż tal-ġisem SC kull 24 siegħa
English: There was a higher incidence of gastrointestinal bleeding in the enoxaparin sodium group (0.5%) versus the heparin group (0.1%), while the incidence of intracranial haemorrhage was similar in both groups (0.8% with enoxaparin sodium versus 0.7% with heparin).
Maltese: Kien hemm inċidenza akbar ta' ħruġ ta' demm gastrointestinali fil-grupp ta' enoxaparin sodium (0.5%) versus il-grupp ta' heparin (0.1%), filwaqt li l-inċidenza ta' emorraġija ġol-kranju kienet tixxiebah fiż-żewġ gruppi (0.8% b'enoxaparin sodium versus 0.7% bil-heparin).
English: • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 );
Maltese: • Bi storja ta' tromboċitopenija ikkaġunata mill-heparin (HIT - heparin-induced thrombocytopenia) u medjata b'mod immuni fil-100 jum preċedenti jew fil-preżenza ta' antikorpi li jiċċirkulaw (ara wkoll sezzjoni 4.4 );
English: • Rare: Alopecia*
Maltese: Alopeċja*
English: Both enoxaparin sodium regimens were equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism (DVT and/or PE).
Maltese: Iż-żewġ skedi ta' enoxaparin sodium kienu ekwivalenti għal terapija standard bil-heparin fit-tnaqqis tar-riskju ta' tromboembolizmu rikurrenti fil-vini (DVT u/jew PE).
English: Retroperitoneal haemorrhage : such as haematoma, ecchymosis other than at injection site, wound haematoma, haematuria, epistaxis and gastro-intestinal haemorrhage.
Maltese: Emorraġija wara lperitonew : bħal ematoma, ekkimożi f'postijiet oħra li mhumiex il-post tal-injezzjoni, ematoma fil-ferita, ematurja, epistassi, u emorraġija gastrointestinali.
English: Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for STEMI (see sections 4.2 and 5.2).
Maltese: Huwa rrakkomandat monitoraġġ kliniku b'attenzjoni u jista' jiġi kkunsidrat tnaqqis fid-doża f'pazjenti li għandhom aktar minn 75 sena ttrattati għal STEMI (ara sezzjonijiet 4.2 u 5.2).
English: Based on literature data the use of enoxaparin sodium 4,000 IU (40 mg) in cirrhotic patients (Child-Pugh class B-C) appears to be safe and effective in preventing portal vein thrombosis.
Maltese: IU (40 mg) f'pazjenti ċirrotiċi (Child-Pugh klassi B-C) jidher li huwa sigur u effettiv biex jevita trombożi fil-vina portali.
English: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).
Maltese: Prodotti mediċinali li jżidu il-livelli tal-potassium fis-serum jistgħu jingħataw flimkien ma' enoxaparin sodium b'monitoraġġ kliniku u tal-laboratorju b'attenzjoni (ara sezzjonijiet 4.4 u 4.8).
English: The risk of antibody-mediated HIT also exists with LMWHs.
Maltese: Ir-riskju ta' HIT medjata minn antikorpi teżisti wkoll b'LMWHs.
English: Other medicines and Thorinane
Maltese: Mediċini oħra u Thorinane
English: o For dosage in patients ≥ 75 years of age, see paragraph “Elderly”.
Maltese: o Għad-dożaġġ f'pazjenti ≥ 75 sena, ara l-paragrafu “Anzjani”.
English: Overall list of possible side effects: Very common (may affect more than 1 in 10 people)
Maltese: Lista totali ta' effetti sekondarji possibbli: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10)
English: Your doctor should discuss this with you
Maltese: Trattament ta' DVT u PE
English: Switch between enoxaparin sodium and oral anticoagulants
Maltese: Bidla bejn enoxaparin sodium u antikoagulanti mill-ħalq
English: Thrombocytopen ia
Maltese: Tromboċitopen ija
English: Intracranial haemorrhage,
Maltese: Emorraġija ġol-kranju,
English: These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see section 4.4).
Maltese: Dawn ir-reazzjonijiet wasslu għal gradi differenti ta' ħsarat newroloġiċi inkluż paraliżi għal tul ta' żmien jew permanenti (ara sezzjoni 4.4)
English: Uncommon: Thrombocytopen ia
Maltese: Mhux komuni: Tromboċitopen ija
English: When non-weight adjusted dosing was administered, it was found after a single-SC 4,000 IU (40 mg) dose, that anti-Xa exposure is 52% higher in low-weight women (<45 kg) and 27% higher in low-weight men (<57 kg) when compared to normal weight control subjects (see section 4.4).
Maltese: Meta ngħataw dożi li ma kinux aġġustati għall-piż, instab li wara doża waħda ta' 4,000 UI (40 mg) SC, lesponiment anti-Xa jkun 52% ogħla f'nisa b'piż baxx (<45 kg) u 27% ogħla f'irġiel b'piż baxx (<57 kg) meta mqabbla ma' individwi bħala kontroll li kellhom piż normali (ara sezzjoni 4.4).
English: • Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
Maltese: • It-tabib tiegħek normalment jgħidlek tieħu aspirina (acetylsalicylic acid) ukoll.
English: • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
Maltese: • Bi fsada attiva sinifikanti b'mod kliniku u kondizzjonijiet b'riskju kbir għal emorraġija, inkluż puplesija emorraġika riċenti, ulċera gastrointestinali, preżenza ta' neoplażmu malinn b'riskju kbir ta' ħruġ ta' demm, operazzjonijiet riċenti fil-moħħ, fis-sinsla jew fl-għajnejn, variċi magħrufa jew issuspettati fl-esofagu, formazzjonijiet arterjovenużi ħżiena, anewriżmu vaskulari jew anormalitajiet vaskulari maġġuri ġewwa s-sinsla jew ġewwa ċ-ċerebrum;
English: • Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
Maltese: • Profilassi ta' mard tromboemboliku fil-vini f'pazjenti li jeħtieġu kura medika li għandhom mard akut (bħal insuffiċjenza akuta tal-qalb, insuffiċjenza respiratorja, infezzjonijiet severi jew mard rewmatiku) u mobilita` mnaqqsa li qegħdin f'riskju akbar ta' tromboemboliżmu fil-vini.
English: Patients received enoxaparin sodium (4,000 IU (40 mg) SC) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin sodium or placebo for another 21 days.
Maltese: Il-pazjenti rċivew enoxaparin sodium (4,000 UI (40 mg) SC) kuljum għal bejn 6 u 10 ijiem u ġew assenjati b'mod arbitrarju biex jew jirċievu enoxaparin sodium jew plaċebo għal 21 jum ieħor.
English: No dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment.
Maltese: Ma huwa rrakkomandat l-ebda aġġustament fid-doża ta' pazjenti b'indeboliment moderat (teħħija talkreatinina 30-50 mL/min) u ħafif (teħħija tal-kreatinina 50-80 mL/min) tal-kliewi.
English: - Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to Thorinane Stop taking the vitamin-K antagonist.
Maltese: - Bidla minn mediċini li jraqqu d-demm imsejħa antagonisti tal-vitamina K (eż. warfarin) għal Thorinane
English: In a double blind multicenter, parallel group study, enoxaparin sodium 2,000 IU (20 mg) or 4,000 IU (40 mg) once a day SC was compared to placebo in the prophylaxis of DVT in medical patients with severely restricted mobility during acute illness (defined as walking distance of <10 meters for ≤3 days).
Maltese: Fi studju b'ħafna ċentri, bi grupp parallell, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, enoxaparin sodium 2,000 UI (20 mg) jew 4,000 UI (40 mg) darba kuljum SC tqabbel ma' plaċebo fil-profilassi ta' DVT f'pazjenti li jeħtieġu kura medika b'mobilità ristretta b'mod sever waqt mard akut (iddefinita bħala mixi distanza ta' <10 metri għal ≤3 ijiem).
English: The incidence of major bleeding at 30 days was significantly higher (p<0.0001) in the enoxaparin sodium group (2.1%) versus the heparin group (1.4%).
Maltese: L-inċidenza ta' ħruġ ta' demm maġġuri mat-30 jum kienet ogħla b'mod sinigfikanti (p<0.0001) fil-grupp ta' enoxaparin sodium (2.1%) versus il-grupp ta' heparin (1.4%).
English: • Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality)
Maltese: • Komunni ħafna: Żidiet fl-enzimi tal-fwied (l-aktar it-transaminases > 3 darbiet l-ogħla limitu tan
English: • Skin necrosis / cutaneous vasculitis
Maltese: • Nekrożi fil-ġilda/vaskulite kutanja
English: The beneficial effect of enoxaparin sodium on the primary end point was consistent across key subgroups including age, gender, infarct location, history of diabetes, history of prior myocardial infarction, type of fibrinolytic administered, and time to treatment with study drug.
Maltese: L-effett vantaġġjuż ta' enoxaparin sodium fuq l-iskop finali primarju kien konsistenti fis-sottogruppi importanti inkluż l-età, is-sess tal-persuna, il-post tal-infart, l-istorja ta' dijabete, l-istorja ta' infart mijokardijaku preċedenti, it-tip ta' fibrinolitiku mogħti, u l-ħin għat-trattament bil-mediċina tal-istudju.
English: 10 pre-filled syringes
Maltese: .9 Doża eċċessiva
English: The quantitative determination of anti-Xa and anti-IIa pharmacokinetic activities was conducted by validated amidolytic methods.
Maltese: Id-deteminazzjoni kwantitattiva tal-attivitajiet farmakokinetiċi anti-Xa u anti-IIa saret b'metodi amidolitiċi validati.
English: In clinical studies, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see section 4.4 and 'Description of selected adverse reactions' below).
Maltese: Fi studji kliniċi, emorraġiji, tromboċitopenija u tromboċitożi kienu l-aktar reazzjonijiet irrappurtati b'mod komuni (ara sezzjoni 4.4 u d-'Deskrizzjoni ta' reazzjonijiet avversi magħżula' taħt).
English: Thorinane 10,000 IU (100 mg)/1.0 mL
Maltese: IU (100 mg)/1.0 mL
English: • Extended prophylaxis of VTE following orthopaedic surgery In a double blind study of extended prophylaxis for patients undergoing hip replacement surgery, 179 patients with no venous thromboembolic disease initially treated, while hospitalized, with enoxaparin sodium 4,000 IU (40 mg) SC, were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n=90) once a day SC or to placebo (n=89) for 3 weeks.
Maltese: Fi studju, ta' profilassi estiża għall-pazjenti li jkunu qed jagħmlu operazzjoni ta' bdil tal-għadma talġenbejn, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, 179 pazjent mingħajr l-ebda mard tromboemboliku fil-vini ttrattati inizjalment, waqt li kienu l-isptar, b'enoxaparin sodium 4,000 UI (40 mg) SC, intgħażlu b'mod arbitrarju wara li ġew liċenzjati għal skeda ta' għoti ta' dożi jew ta' enoxaparin sodium 4,000 UI (40 mg) (n=90) darba kuljum SC jew għal plaċebo (n=89) għal 3 ġimgħat.
English: Volume to inject when diluted to a final concentration of 300 IU (3 mg) / mL
Maltese: Volum li għandu jiġi injettat meta jkun iddilwit għal konċentrazzjoni finali ta' 300 IU (3 mg) / mL
English: Haemorrhages
Maltese: Pożoloġija
English: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2).
Maltese: - Trombolitiċi (eż. alteplase, reteplase, streptokinase, tenecteplase, urokinase) u antikoagulanti
English: This difference persisted at three months [13.8% vs. 5.5% (n=23 vs 9), p=0.01].
Maltese: Din iddifferenza ippersistiet sa tliet xhur [13.8% vs. 5.5% (n=23 vs 9), p=0.01]. Ma kien hemm l-ebda differenzi fir-rati ta' fsada jew kumplikazzjonijiet oħra waqt il-perjodu fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża jew il-perjodu ta' segwitu.
English: At higher doses, increases in activated partial thromboplastin time (aPTT), and activated clotting time (ACT) may occur.
Maltese: B'dożi ogħla, jistgħu jseħħu żidiet fil-ħin parzjali ta' tromboplastin attivat (aPTT - activated partial thromboplastin time), u fil-ħin ta' tagħqid tad-demm attivat (ACT - activated clotting time).
English: Enoxaparin sodium is administered by deep SC injection.
Maltese: Enoxaparin sodium jingħata permezz ta' injezzjoni SC fil-fond.
English: There was a significant treatment benefit of enoxaparin sodium, as compared with unfractionated heparin, in patients who underwent percutaneous coronary intervention within 30 days after randomization (23 percent reduction in relative risk) or who were treated medically (15 percent reduction in relative risk, p=0.27 for interaction).
Maltese: Kien hemm benefiċċju sinifikanti ta' trattament ta' enoxaparin sodium, meta mqabbel ma' heparin mhux frazzjonat, f'pazjenti li għamlu intervent koronarju perkutanju fi żmien 30 jum mill-għażla arbitrarja (tnaqqis ta' 23 fil-mija fir-riskju relattiv) jew li kienu ttrattati b'mod mediku (tnaqqis fir-riskju relattiv ta' 15 fil-mija, p=0.27 għal interazzjoni).
English: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients Individual thromboembolic risk for patients can be estimated using validated risk stratification model.
Maltese: Ir-riskju tromboemboliku individwali għall-pazjenti jista' jiġi stmat bl-użu ta' mudell validat ta' stratifikazzjoni tar-riskju.
English: For patients with creatinine clearance [15-30 mL/minute], additional considerations are necessary because elimination of enoxaparin sodium is more prolonged (see section 4.2).
Maltese: Għall-pazjenti bi teħħija talkreatinina [15 -30 mL/minuta], huma meħtieġa kunsiderazzjonijiet addizzjonali minħabba li leliminazzjoni ta' enoxaparin sodium tkun imdewma aktar (ara sezzjoni 4.2).
English: System Organ Class
Maltese: Sistemi u talOrgani
English: *The 95% Confidence Intervals for the treatment differences for total VTE were: - enoxaparin sodium once a day versus heparin (-3.0 to 3.5)
Maltese: VTE = avveniment tromboemboliku fil-vini (DVT u/jew PE) * L-intervalli ta' kunfidenza ta' 95% għad-differenzi fit-trattament għal VTE totali kienu: - enoxaparin sodium darba kuljum versus heparin (-3.0 sa 3.5) - enoxaparin sodium kull 12-il siegħa versus heparin (-4.2 sa 1.7).
English: Enoxaparin sodium pharmacokinetics appeared similar than control population, after a single 25 IU, 50 IU or 100 IU/kg (0.25, 0.50 or 1.0 mg/kg) IV dose however, AUC was two-fold higher than control.
Maltese: UI jew 100 UI/kg (0.25, 0.50 jew 1.0 mg/kg) IV madankollu, l-AUC kienet darbtejn aktar millkontroll.
English: • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery.
Maltese: • Trattament ta' trombożi fil-vini fil-fond (DVT - deep vein thrombosis) u emboliżmu fil-vini (PEpulmonary embolism) ħlief PE li x'aktarx tkun teħtieġ terapija trombolitika jew operazzjoni.
English: In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours.
Maltese: Fl-istudji kliniċi għat-trattament ta' anġina mhux stabbli u infart mijokardijaku mingħajr mewġ Q, id-dożi kienu 100 UI/kg (1 mg/kg) SC kull 12-il siegħa, u fl-istudju kliniku għat-trattament ta' STEMI akut l-iskeda ta' enoxaparin sodium kienet 3,000 UI (30 mg) IV f'daqqa segwita minn 100 UI/kg (1 mg/kg) SC kull 12-il siegħa.
English: Treatment of acute ST-segment elevation myocardial infarction In a large multicenter study, 20,479 patients with STEMI eligible to receive fibrinolytic therapy were randomized to receive either enoxaparin sodium in a single 3,000 IU (30 mg) IV bolus plus a 100 IU/kg (1 mg/kg) SC dose followed by an SC injection of 100 IU/kg (1 mg/kg) every 12 hours or IV unfractionated heparin adjusted based on aPTT for 48 hours.
Maltese: Trattament ta' infart mijokardijaku akut b'elevazzjoni fis-segment ST Fi studju kbir b'ħafna ċentri, 20,479 pazjent bi STEMI eliġibbli biex jirċievu terapija fibrinolitika ntagħżlu b'mod arbitrarju biex jew jirċievu enoxaparin sodium b'doża f'daqqa ta' 3,000 UI (30 mg) IV flimkien ma' doża ta' 100 UI/kg (1 mg/kg) SC segwita minn injezzjoni SC ta' 100 UI/kg (1 mg/kg) kull 12-il siegħa jew heparin IV mhux frazzjonat aġġustat abbażi tal-aPTT għal 48 siegħa.
English: Treatment of deep vein thrombosis with or without pulmonary embolism In a multicenter, parallel group study, 900 patients with acute lower extremity DVT with or without PE were randomized to an inpatient (hospital) treatment of either (i) enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day SC, (ii) enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours SC, or (iii) heparin IV bolus (5,000 IU) followed by a continuous infusion (administered to achieve an aPTT of 55 to 85 seconds).
Maltese: Trattament ta' trombożi fil-vini fil-fond b'emboliżmu fil-pulmuni jew mingħajru Fi studju b'ħafna ċentri, bi grupp parallell, 900 pazjent b'DVT akuta f'riġel b'PE jew mingħajru ntagħżlu b'mod arbitrarju għal trattament bħala pazjenti rikoverati fi sptar jew ta' (i) enoxaparin sodium 150 UI/kg (1.5 mg/kg) darba kuljum SC, (ii) enoxaparin sodium 100 UI/kg (1 mg/kg) kull 12-il siegħa SC, jew (iii) heparin (5,000
English: • For treatment of unstable angina and NSTEMI, the recommended dose of enoxaparin sodium is 100 IU/kg (1 mg/kg) every 12 hours by SC injection administered in combination with antiplatelet therapy.
Maltese: • Għat-trattament ta' anġina mhux stabbli u NSTEMI, id-doża rrakkomandata ta' enoxaparin sodium hija 100 UI/kg (1 mg/kg) kull 12-il siegħa permezz ta' injezzjoni SC mogħtija flimkien ma' terapija kontra l-plejtlits.
English: In a study conducted in patients with advanced cirrhosis treated with enoxaparin sodium 4,000 IU (40 mg) once daily, a decrease in maximum anti-Xa activity was associated with an increase in the severity of hepatic impairment (assessed by Child-Pugh categories).
Maltese: Fi studju li sar f'pazjenti b'ċirrożi avvanzata li kienu ttrattati b'enoxaparin sodium 4,000 UI (40 mg) darba kuljum, tnaqqis fl-attivita massima ta' anti-Xa kien assoċjat ma' żieda fis-severità ta' indeboliment talfwied (stmat bil-kategoriji ta' Child-Pugh).
English: Injection volume and dose concentration over the range 100-200 mg/mL does not affect pharmacokinetic parameters in healthy volunteers.
Maltese: Il-volum tal-injezzjoni u l-konċentrazzjoni tad-doża fuq il-firxa ta' 100-200 mg/mL ma taffettwax ilparametri farmakokinetiċi f'voluntiera f'saħħithom.
English: Thorinane 2,000 IU (20 mg)/0.2 mL solution for injection
Maltese: Thorinane 2,000 IU (20 mg)/0.2 mL soluzzjoni għall-injezzjoni
English: Prophylaxis of venous thromboembolism in medical patients The recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily by SC injection.
Maltese: Id-doża rrakkomandata ta' enoxaparin sodium hija 4,000 UI (40 mg) darba kuljum permezz ta' injezzjoni SC.
English: Each prefilled syringe contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 100 mg) f'1.0 mL ilma għall-injezzjonijiet.
English: The oral absorption of enoxaparin sodium is unlikely.
Maltese: enoxaparin sodium.
English: Obese patients are at higher risk for thromboembolism.
Maltese: Pazjenti b'ħafna piż żejjed jkunu f'riskju akbar ta' tromboemboliżmu.
English: Treatment of unstable angina and non ST elevation myocardial infarction In a large multicenter study, 3,171 patients enrolled at the acute phase of unstable angina or non-Q-wave myocardial infarction were randomized to receive in association with acetylsalicylic acid (100 to 325 mg once daily), either SC enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours or IV unfractionated heparin adjusted based on aPTT.
Maltese: Trattament ta' anġina mhux stabbli u infart mijokardijaku mingħajr elevazzjoni f'ST Fi studju kbir b'ħafna ċentri, 3,171 pazjent irreġistrati fil-fażi akuta ta' anġina mhux stabbli jew infart mijokardijaku mingħajr mewġ Q intagħżlu b'mod arbitrarju biex flimkien ma' acetylsalicylic acid (100 sa 325 mg darba kuljum), jew jirċievu SC enoxaparin sodium 100 UI/kg (1 mg/kg) kull 12-il siegħa jew inkella heparin IV mhux frazzjonat aġġustat abbażi tal-aPTT.
English: Preoperative initiation (2 hours before surgery) of enoxaparin sodium 2,000 IU (20 mg) was proven effective and safe in moderate risk surgery.
Maltese: Il-bidu ta' enoxaparin sodium 2,000 UI (20 mg) qabel operazzjoni (sagħtejn qabel l-operazzjoni) ġie ppruvat li huwa effettiv u sikur f'operazzjoni b'riskju moderat.
English: • Rare: Cutaneous vasculitis*, skin necrosis* usually occurring at the injection site (these phenomena have been usually preceded by purpura or erythematous plaques, infiltrated and painful).
Maltese: Vaskulite kutanja *, nekrożi fil-ġilda* li s-soltu sseħħ fil-post tal-injezzjoni (qabel jiġru dawn il fenomeni s-soltu jkun hemm purpura jew plakek ertematużi, infiltrati u bl-uġigħ).
English: Plasma anti-IIa activity after SC administration is approximately ten-fold lower than anti-Xa activity.
Maltese: L-attività anti-IIa fil-plażma wara għoti SC huwa madwar għaxar darbiet inqas mill-attività anti-Xa.