FrancophonIA/ELRC3.0 huggingface dataset:
English: The absolute bioavailability of enoxaparin sodium after SC injection, based on anti-Xa activity, is close to 100%.
Maltese: Il-bijodisponibbiltà assoluta ta' enoxaparin sodium wara injezzjoni SC, ibbażata fuq l-attività anti-Xa, hija qrib il-100%.
English: - Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).
Maltese: segment elevation myocardial infarction) inkluż pazjenti li se jiġu mmaniġġjati b'mod mediku jew b'intervent koronarju perkutanju sussegwenti (PCI - percutaneous coronary intervention).
English: 50,000 IU (500 mg)/5 mL
Maltese: 50,000 UI (500 mg)/5 mL
English: You will be given 2,000 IU
Maltese: UI, 4,000
English: [To be completed nationally] [See Annex I - To be completed nationally] [For referral procedures]
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] [For referral procedures]
English: • Rare: Anaphylactic/Anaphylactoid reactions including shock*
Maltese: • Rari: Reazzjonijiet anafilattiċi/anafilaktojd inkluż xokk*
English: General characteristics
Maltese: Karatterisitċi ġenerali
English: Investigations • Rare: Hyperkalaemia* (see sections 4.4 and 4.5)
Maltese: Iperkalimja*(ara sezzjonijiet 4.4 u 4.5)
English: 30,000 IU (300 mg) /3 mL
Maltese: 30,000 UI (300 mg)/3 mL
English: Haemorrhage α Rare:
Maltese: Disturbi vaskulari • Rari:
English: 4,000 IU (40 mg) /0.4 mL
Maltese: 4,000 UI (40 mg) /0.4 mL
English: SC injection
Maltese: .2 Inkompatibbilitajiet Injezzjoni SC
English: 15,000 IU (150 mg) /1 mL
Maltese: 15,000 UI (150 mg) /1 mL
English: 6,000 IU (60 mg) /0.6 mL
Maltese: 6,000 UI (60 mg) /0.6 mL
English: Similar to the first study the incidence of VTE during extended prophylaxis was significantly lower for enoxaparin sodium compared to placebo for both total VTE (enoxaparin sodium 21 [16%] versus placebo 45 [34.4%]; p=0.001) and proximal DVT (enoxaparin sodium 8 [6.1%] versus placebo 28 [21.4%]; p=<0.001).
Maltese: Simili għall-ewwel studju l inċidenza ta' VTE waqt profilassi estiża kienet b'mod sinifikanti aktar baxxa għal enoxaparin sodium meta mqabbla mal-plaċebo kemm għat-total ta' VTE (enoxaparin sodium 21 [16%] versus plaċebo 45 [34.4%]; p=0.001) u DVT prossimali (enoxaparin sodium 8 [6.1%] versus plaċebo 28 [21.4%]; p=<0.
English: System Organ Class
Maltese: Klassi tasSistem i u talOrgan i
English: Enoxaparin sodium has shown no mutagenic activity based on in vitro tests, including the Ames test, mouse lymphoma cell forward mutation test, and no clastogenic activity based on an in vitro human lymphocyte chromosomal aberration test, and the in vivo rat bone marrow chromosomal aberration test.
Maltese: Enoxaparin ma wera l-ebda attività mutaġenika abbażi ta' testijiet in vitro, inkluż it-test Ames, test talmutazzjoni 'il quddiem taċ-ċellula tal-limfoma tal-ġurdien, u l-ebda attività klastoġenika abbażi tat-test talaberrazzjoni tal-kromosomi tal-limfoċita tal-bniedem in vitro, u t-test tal-aberrazzjoni tal-kromosomi talmudullun tal-għadam tal-far in vivo.
English: Pharmacotherapeutic group: Antithrombotic agent, heparin group, ATC code: B01A B05
Maltese: Sustanza antitrombotika, grupp tal-heparin, kodiċi ATC:
English: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids.
Maltese: antiaggregant (kardjoprotezzjoni), clopidogrel, ticlopidine, u antagonisti tal-glikoproteina IIb/IIIa indikati fis-sindrom koronarju akut minħabba r-riskju ta' fsada, - Dextran 40,
English: Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water (see section 4.2).
Maltese: Enoxaparin sodium jista' jingħata mingħajr periklu b'soluzzjoni ta' normal saline (0.9%) jew 5% dextrose fl-ilma (ara sezzjoni 4.2).
English: 12,000 IU (120 mg) / 0.8 mL
Maltese: 12,000 UI (120 mg) / 0.8 mL
English: 2,000 IU (20 mg) /0.2 mL
Maltese: 2,000 UI (20 mg) /0.2 mL
English: - Changing from LOVENOX (and associated names) to treatment with direct oral anticoagulant Stop taking LOVENOX (and associated names).
Maltese: - Bidla minn LOVENOX (u ismijiet assoċjati) għal trattament b'antikoagulant orali dirett Waqqaf LOVENOX (u ismijiet assoċjati).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial (10.0 mL) contains 10,000 IU (100 mg) enoxaparin sodium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed (10.0 mL) fih 10,000 UI (100 mg) enoxaparin sodium.
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: 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: Ampoules
Maltese: Ampulli
English: 15,000 IU/mL (150 mg/mL) solution for injection:
Maltese: 15,000 IU/mL (150 mg/mL) soluzzjoni għall-injezzjoni:
English: Common: Haemorrhage α
Maltese: Komuni ħafna: Emorraġija α
English: 8,000 IU (80 mg) /0.8 mL
Maltese: 8,000 UI (80 mg) /0.8 mL
English: • Uncommon: Local irritation, skin necrosis at injection site
Maltese: • Mhux komuni: Irritazzjoni lokali, nekroliżi tal-ġilda fil-post tal-injezzjoni Investigazzjonijiet
English: 100,000 IU (1000 mg)/10 mL
Maltese: 100,000 UI (1000 mg)/10 mL
English: One vial (3.0 mL) contains 30,000 IU (300 mg) enoxaparin sodium One vial (5.0 mL) contains 50,000 IU (500 mg) enoxaparin sodium One vial (10.0 mL) contains 100,000 IU (1,000 mg) enoxaparin sodium
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed (3.0 mL) fih 30,000 UI (300 mg) enoxaparin sodium Kunjett wieħed (5.0 mL) fih 50,000 UI (500 mg) enoxaparin sodium Kunjett wieħed (10.0 mL) fih 100,000 UI (1,000 mg) enoxaparin sodium
English: You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of LOVENOX (and associated names) each day.
Maltese: Inti se tingħata 2,000 UI (20 mg) jew 4,000 UI (40 mg) ta' LOVENOX (u ismijiet assoċjati) kuljum.
English: - Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to LOVENOX (and associated names)
Maltese: - Bidla minn mediċini li jraqqu d-demm imsejħa antagonisti tal-vitamina K (eż. warfarin) għal LOVENOX (u ismijiet assoċjati)
English: The mean maximum anti-IIa activity level is observed approximately 3 to 4 hours following SC injection and reaches 0.13 IU/mL and 0.19 IU/mL following repeated administration of 100 IU/kg (1 mg/kg) twice daily and 150 IU/kg (1.5 mg/kg) once daily, respectively.
Maltese: 0.13 UI/mL u 0.19 UI/mL wara għoti ripetut ta' 100 UI/kg (1 mg/kg) darbtejn kuljum u 150 UI/kg (1.5 mg/kg) darba kuljum, rispettivament.
English: Major bleeding were respectively 1.7% in the enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day group, 1.3% in the enoxaparin sodium 100 IU/kg (1mg/kg) twice a day group and 2.1% in the heparin group.
Maltese: Fsada maġġuri kienet rispettivament 1.7% fil-grupp ta' enoxaparin sodium 150 UI/kg (1.5 mg/kg) darba kuljum, 1.3% fil-grupp ta' enoxaparin sodium 100 UI/kg (1mg/kg) darbtejn kuljum u 2.1% fil-grupp ta' heparin.
English: The occurrence of total and major bleeding were respectively 8.6% and 1.1% in the placebo group, 11.7% and 0.3% in the enoxaparin sodium 2,000 IU (20 mg) group and 12.6% and 1.7% in the enoxaparin sodium 4,000 IU (40 mg) group.
Maltese: 0.3% fil-grupp ta' enoxaparin sodium 2,000 UI (20 mg) u 12.6% u 1.7% fil-grupp ta' enoxaparin sodium 4,000 UI (40 mg).
English: {MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
Maltese: {XX/SSSS} {JJ/XX/SSSS} {JJ xahar SSSS}
English: • Common: Injection site haematoma, injection site pain, other injection site reaction (such as oedema, haemorrhage, hypersensitivity, inflammation, mass, pain, or reaction)
Maltese: • Komuni: Ematoma fil-post tal-injezzjoni, uġigħ fil-post tal-injezzjoni, reazzjoni oħra fil-post tal injezzjoni (bħal edima, emorraġija, sensittività eċċessiva, infjammazzjoni, massa, uġigħ jew reazzjoni)
English: 10,000 IU (100 mg) /1.0 mL
Maltese: 10,000 UI (100 mg) /1.0 mL
English: Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for ST-segment elevation myocardial infarction (STEMI) (see section 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 infart mijokardijaku b'elevazzjoni fis-segment ST (STEMI - ST-segment elevation myocardial infarction) (ara sezzjoni 5.2).
English: Common: Thrombocytosis β
Maltese: Tromboċitożi β
English: One 3.0 mL pen contains enoxaparin sodium 40,000 IU anti-Xa activity (equivalent to 400 mg), equivalent to 10 single doses of 4,000 IU (40 mg) enoxaparin sodium, + 45 mg benzyl alcohol in 3.0 mL water for injections
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 400 mg), ekwivalenti għal 10 dożi waħdiet ta' 4,000 UI (40 mg) enoxaparin sodium + 45 mg benzyl alcohol f'3.0 mL ilma għall-injezzjonijiet.
English: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac,
Maltese: Dawn is-sustanzi jinkludu prodotti mediċinali bħal: - Salicylates sistemiċi, acetylsalicylic acid bid-dożi antiinfjammatorji, u NSAIDs inkluż ketorolac,
English: Important information about some of the ingredients of LOVENOX (and associated names) LOVENOX (and associated names) contains benzyl alcohol [benzyl alcohol content to be completed nationally].
Maltese: Informazzjoni importanti dwar xi wħud mis-sustanzi ta' LOVENOX (u ismijiet assoċjati) LOVENOX (u ismijiet assoċjati) fih benzyl alcohol [kontenut ta' benzyl alcohol biex jimtela mill-pajjiż partikolari].
English: 12 hours before your operation.
Maltese: 12-il siegħa qabel l-operazzjoni u titkompla 12-il siegħa wara l-operazzjoni.
English: These anticoagulant activities are mediated through anti-thrombin III (ATIII) resulting in antithrombotic activities in humans.
Maltese: Dawn lattivitajiet antikoagulanti huma medjati permezz ta' antitrombin III (ATIII) li jwassal għal attivitajiet antitrombotiċi fil-bnedmin.
English: Appropriate antiplatelet therapy such as oral acetylsalicylic acid (75 mg to 325 mg once daily) should be administered concomitantly unless contraindicated.
Maltese: Terapija xierqa kontra l-plejtlits bħal acetylsalicylic acid mill ħalq (75 mg sa 325 mg darba kuljum) għandha tingħata fl-istess waqt ħlief jekk tkun kontraindikata.
English: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH), to benzyl alcohol or to any of the excipients listed in section 6.1;
Maltese: • B'sensittività eċċessiva għal enoxaparin sodium, heparin jew id-derivati tiegħu, inkluż heparins b'piż molekulari baxx oħra (LMWH - low molecular weight heparins), għal benzyl alcohol jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1;
English: Based on literature data the use of enoxaparin sodium 4,000 IU (40 mg) in cirrhotic patients (ChildPugh 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: - Changing from treatment with direct oral anticoagulant to LOVENOX (and associated names) Stop taking direct oral anticoagulant.
Maltese: - Bidla minn trattament b'antikoagulant orali dirett għal LOVENOX (u ismijiet assoċjati) Ieqaf ħu l-antikoagulant orali dirett.
English: However, even with high doses of protamine, the anti-Xa activity of enoxaparin sodium is never completely neutralized (maximum about 60%) (see the prescribing information for protamine salts).
Maltese: protamine, l-attività anti-Xa ta' enoxaparin sodium qatt ma tiġi newtralizzata kompletament (massimu madwar 60%) (ara l-informazzjoni dwar kif protamine salts għandhom jiġu ordnati b'riċetta).
English: LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection
Maltese: - LOVENOX (u ismijiet assoċjati) 12,000 UI (120 mg)/0.8 mL soluzzjoni għall-injezzjoni - LOVENOX (u ismijiet assoċjati) 15,000 UI (150 mg)/1 mL soluzzjoni għall-injezzjoni
English: IV (Bolus) Injection (for acute STEMI indication only):
Maltese: Injezzjoni IV (f'Daqqa) (għall-indikazzjoni ta' STEMI akut biss):
English: For continuous techniques, a similar delay of 24 hours should be observed before removing the catheter.
Maltese: Għal tekniki kontinwi, dewmien simili ta' mill-anqas 24 siegħa għandu jiġi osservat qabel ma jitneħħa l-kateter.
English: As benzyl alcohol may cross the placenta, it is recommended to use a formulation that does not contain benzyl alcohol.
Maltese: Minħabba li benzyl alcohol jista' jgħaddi minn ġol-plaċenta, huwa rrakkomandat li tintuża formulazzjoni li ma fihiex benzyl alcohol.
English: OUTER BOX PRE FILLED SYRINGE
Maltese: KARTUNA TA' BARRA PINNA
English: Initiate dosing with 75 IU/kg (0.75 mg/kg) SC every 12 hours (maximum 7,500 IU (75 mg) for each of the first two SC doses only, followed by 75 IU/kg (0.75 mg/kg) SC dosing for the remaining doses).
Maltese: Ibda l-għoti b'doża ta' 75 UI/kg (0.75 mg/kg) SC kull 12-il siegħa (massimu ta' 75 UI (75 mg) għal kull waħda mill-ewwel żewġ dożi SC biss, segwita minn għoti ta' doża ta' 75 UI/kg (0.75 mg/kg) SC għallkumplament ta-dożi).
English: Treatment of DVT and PE
Maltese: Trattament f'pazjenti b'DVT b'PE
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 lowweight 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: Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs.
Maltese: • Ġenerali Enoxaparin sodium ma jistax jinbidel (unità għal kull unità) ma' LMWHs oħra.
English: Pre-Filled Syringes:
Maltese: ISTRUZZJONIJIET DWAR L-UŻU:
English: LOVENOX (and associated names) contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH).
Maltese: X'inhu LOVENOX (u ismijiet assoċjati) u għalxiex jintuża LOVENOX (u ismijiet assoċjati) fih is-sustanza attiva msejħa enoxaparin sodium li hija heparin b'piż molekulari baxx (LMWH - low molecular weight heparin).
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
English: 15,000 IU/mL (150 mg/mL) solution for injection
Maltese: 15,000 UI/mL (150 mg/mL) soluzzjoni għall-injezzjoni
English: One pre-filled syringe (0.2 mL) contains 2,000 IU (20 mg) enoxaparin sodium One pre-filled syringe (0.4 mL) contains 4,000 IU (40 mg) enoxaparin sodium One pre-filled syringe (0.6 mL) contains 6,000 IU (60 mg) enoxaparin sodium One pre-filled syringe (0.8 mL) contains 8,000 IU (80 mg) enoxaparin sodium One pre-filled syringe (0.8 mL) contains 12,000 IU (120 mg) enoxaparin sodium One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium One pre-filled syringe (1 mL) contains 15,000 IU (150 mg) enoxaparin sodium
Maltese: Siringa waħda mimlija għal-lest (0.2 mL) fiha 2,000 UI (20 mg) enoxaparin sodium Siringa waħda mimlija għal-lest (0.4 mL) fiha 4,000 UI (40 mg) enoxaparin sodium Siringa waħda mimlija għal-lest (0.6 mL) fiha 6,000 UI (60 mg) enoxaparin sodium Siringa waħda mimlija għal-lest (0.8 mL) fiha 8,000 UI (80 mg) enoxaparin sodium Siringa waħda mimlija għal-lest (0.8 mL) fiha 12,000 UI (120 mg) enoxaparin sodium Siringa waħda mimlija għal-lest (1 mL) fiha 10,000 UI (100 mg) enoxaparin sodium Siringa waħda mimlija għal-lest (1 mL) fiha 15,000 UI (150 mg) enoxaparin sodium
English: See “Do not use LOVENOX (and associated names)”.
Maltese: Ara “Tużax LOVENOX (u ismijiet assoċjati)”.
English: The rate of the 30 day composite endpoint of death, myocardial re-infarction or intracranial haemorrhage (a measure of net clinical benefit) was significantly lower (p<0.0001) in the enoxaparin sodium group (10.1%) as compared to the heparin group (12.2%), representing a 17% relative risk reduction in favour of treatment with enoxaparin sodium.
Maltese: 1%) meta mqabbla mal-grupp ta' heparin (12.2%), li tirrapreżenta tnaqqis ta' 17% fir-riskju relattiv favur it-trattament b'enoxaparin sodium.
English: Dosage table for patients with severe renal impairment (creatinine clearance [15-30] mL/min): Indication
Maltese: [15-30] mL/min): Indikazzjoni
English: One vial contains enoxaparin sodium 100,000 IU anti-Xa activity (equivalent to 1000 mg) + 150 mg benzyl alcohol in 10.0 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 1,000 mg) + 150 mg benzyl alcohol f'10.0 mL ilma għall-injezzjonijiet.
English: One vial contains enoxaparin sodium 50,000 IU anti-Xa activity (equivalent to 500 mg) + 75 mg benzyl alcohol in 5.0 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 500 mg) + 75 mg benzyl alcohol f'5.0 mL ilma għall-injezzjonijiet.
English: Each prefilled syringe contains enoxaparin sodium 8,000 IU anti-Xa activity (equivalent to 80 mg) in 0.8 mL water for injections.
Maltese: Kull siringa mimlija għal-lest fiha enoxaparin sodium 8,000 UI ta' attività anti-Xa (ekwivalenti għal 80 mg) f'0.8 mL ilma għall-injezzjonijiet.
English: Anti-Xa exposure represented by AUC, at steady-state, is marginally increased in mild (creatinine clearance 50-80 mL/min) and moderate (creatinine clearance 30-50 mL/min) renal impairment after repeated SC 4,000 IU (40 mg) once daily doses.
Maltese: L-esponiment għal anti-Xa rrapreżentat permezz tal-AUC, fl-istat fiss, jiżdied bi ftit f'indeboliment ħafif (teħħija tal kreatinina 50-80 mL/min) u moderat (teħħija tal-kreatinina 30-50 mL/min) tal-kliewi wara dożi SC ta' 4,000 UI (40 mg) darba kuljum.
English: LOVENOX (and associated names) is indicated in adults for:
Maltese: LOVENOX (u ismijiet assoċjati) huwa indikat fl-adulti għal:
English: Enoxaparin sodium treatment is prescribed for an average period of 10 days.
Maltese: enoxaparin sodium (10.
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 il parametri farmakokinetiċi f'voluntiera f'saħħithom.
English: Subcutaneous use.
Maltese: sptar immedjatament.
English: For patients with creatinine clearance [15-30 mL/minute], additional considerations are necessary because elimination of enoxaparin sodium is more prolonged.
Maltese: Għall-pazjenti bi teħħija talkreatinina [15 -30 mL/minuta], huma meħtieġa kunsiderazzjonijiet addizzjonali minħabba li l eliminazzjoni ta' enoxaparin sodium tkun imdewma aktar.
English: Prevention of venous thromboembolic disease associated with surgery
Maltese: • Profilassi estiża ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism) wara operazzjoni ortopedika
English: These included 1,776 for prophylaxis of deep vein thrombosis (DVT) following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of deep vein thrombosis in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without pulmonary embolism (PE), 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI.
Maltese: Dawn kienu jinkludu 1,776 għall-profilassi ta' trombożi fil-vini fil-fond wara operazzjonijiet ortopediċi jew addominali f'pazjenti b'riskju ta' kumplikazzjonijiet tromboemboliċi, 1,169 għall-profilassi ta' trombożi fil-vini fil-fond f'pazjenti li jeħtieġu kura medika morda b'mod akut u b'mobilità ristretta b'mod sever, 559 għat-trattaement ta' DVT b'PE jew mingħajru, 1,578 għat-trattament ta' anġina mhux stabbli u infart mijokardijaku mingħajr mewġ Q u 10,176 għat-trattament ta' STEMI akut.
English: Obese patients are at higher risk for thromboembolism.
Maltese: u mobilita` mnaqqsa li qegħdin f'riskju akbar ta' tromboemboliżmu fil-vini.
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 l eliminazzjoni ta' enoxaparin sodium tkun imdewma aktar (ara sezzjoni 4.2).
English: • Skin necrosis / cutaneous vasculitis
Maltese: • Valvi mekkaniċi prostetiċi tal-qalb
English: The administration of medicinal product containing benzyl alcohol as a preservative to neonates has been associated with a fatal “Gasping Syndrome” (see section 4.3).
Maltese: L-għoti ta' prodott mediċinali li fih benzyl alcohol bħala preservattiv lil trabi tat-twelid ġie assoċjat mal kundizzjoni fatali “Gasping Syndrome” (ara sezzjoni 4.3).
English: Haemorrhages
Maltese: Emorraġiji
English: VTE = venous thromboembolic event (DVT and/or PE) *The 95% Confidence Intervals for the treatment differences for total VTE were: - Enoxaparin sodium once a day versus heparin (-3.0 to 3.5) - enoxaparin sodium every 12 hours versus heparin (-4.2 to 1.7).
Maltese: - 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: However, since renal function is known to decline with age, elderly patients may show reduced elimination of enoxaparin sodium (see section 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 4.4).
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 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: enoxaparin
Maltese: Anzjani
English: LOVENOX (and associated names) 30,000 IU (300 mg)/3 mL solution for injection LOVENOX (and associated names) 50,000 IU (500 mg)/5 mL solution for injection LOVENOX (and associated names) 100,000 IU (1,000 mg)/10 mL solution for injection
Maltese: LOVENOX (u ismijiet assoċjati) 50,000 UI (500 mg)/5 mL soluzzjoni għall-injezzjoni LOVENOX (u ismijiet assoċjati) 100,000 UI (1,000 mg)/10 mL soluzzjoni għall-injezzjoni