FrancophonIA/ELRC3.0 huggingface dataset:
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-Qwave 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: • DVT Only (%)
Maltese: • DVT Biss (%)
English: Package leaflet: Information for the user LOVENOX (and associated names) 10 x 4,000 IU (10 x 40 mg) doses solution for injection in a pen [See Annex I - To be completed nationally] enoxaparin sodium
Maltese: Informazzjoni għall-utent LOVENOX (u ismijiet assoċjati) 10 dożi x 4,000 UI (10 x 40 mg) soluzzjoni għall-injezzjoni f'pinna [Ara Anness I - Biex timtela mill-pajjiż partikolari] enoxaparin sodium
English: Marketing Authorisation Holder and Manufacturer [To be completed nationally] [See Annex I - To be completed nationally] [For referral procedures] {Name and address} {tel} {fax} {e-mail}
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] [For referral procedures, as appropriate]
English: • When you go home, you may need to continue to use LOVENOX (and associated names) and give it yourself (see instructions below on how to do this).
Maltese: • Fl-istess waqt inti se tingħata wkoll LOVENOX (u ismijiet assoċjati) bħala injezzjoni taħt il-ġilda.
English: One vial contains enoxaparin sodium 30,000 IU anti-Xa activity (equivalent to 300 mg) + 45 mg benzyl alcohol in 3.0 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 300 mg) + 45 mg benzyl alcohol f'3.0 mL ilma għall-injezzjonijiet.
English: • Acute coronary syndrome: - Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
Maltese: (NSTEMI - Non ST-segment elevation myocardial infarction), flimkien ma' acetylsalicylic acid mill-ħalq.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen enoxaparin
Maltese: LOVENOX 10 x 4,000 UI (10 x 40 mg) Pinna enoxaparin
English: 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: 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: LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg)/0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection 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 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: mL soluzzjoni għall-injezzjoni LOVENOX (u ismijiet assoċjati) 6,000 UI (60 mg)/0.6 mL soluzzjoni għall-injezzjoni LOVENOX (u ismijiet assoċjati) 8,000 UI (80 mg)/0.8 mL soluzzjoni għall-injezzjoni LOVENOX (u ismijiet assoċjati) 10,000 UI (100 mg)/1 mL soluzzjoni għall-injezzjoni LOVENOX (u ismijiet assoċjati) 30,000 UI (300 mg)/3 mL soluzzjoni għall-injezzjoni 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 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: • Because of the content of benzyl alcohol (see section 6.1), enoxaparin sodium pen formulation must not be given to newborns or premature neonates (see sections 4.4 and 4.6).
Maltese: • Minħabba l-kontenut ta' benzyl alcohol (ara sezzjoni 6.1), il-formulazzjoni ta' enoxaparin sodium f'pinna m'għandhiex tingħata lil trabi tat-twelid u lil trabi li jitwieldu qabel iż-żmien (ara sezzjonijiet 4.4 u 4.6).
English: 4,716 patients underwent percutaneous coronary intervention (PCI) receiving antithrombotic support with blinded study drug.
Maltese: 4,716 il-pazjent għamlu intervent koronarju perkutanju (PCI - percutaneous coronary intervention) waqt li rċivew sostenn antitrombotiku mingħajr ma kienu jafu liema kienet il-mediċina tal-istudju.
English: • Percutaneous coronary revascularization procedures To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, NSTEMI and acute STEMI, adhere precisely to the intervals recommended between enoxaparin sodium injection doses.
Maltese: • Proċeduri ta' rivaskularizzazzjoni koronarja perkutanja Biex jitnaqqas ir-riskju ta' fsada wara l-istrumentazzjoni vaskulari waqt it-trattament għal anġina mhux stabbli, NSTEMI u STEMI akut, żomm eżatt mal-intervalli rrakkomandati bejn l-injezzjoni tad-dożi ta' enoxaparin sodium.
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: Profilassi ta' mard tromboemboliku fil-vini f'pazjenti li se jagħmlu operazzjoni u li għandhom riskju moderat u għoli Ir-riskju tromboemboliku individwali għall-pazjenti jista' jiġi stmat bl-użu ta' mudell validat ta'
English: Do not mix with other products.
Maltese: Tħalltux ma' prodotti oħra.
English: Do not inject LOVENOX (and associated names) into a muscle.
Maltese: Tinjettax LOVENOX (u ismijiet assoċjati) ġo muskolu.
English: No IV initial bolus, 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours
Maltese: UI/kg (1 mg/kg) ta' piż tal-ġisem SC u imbagħad 100 UI/kg (1 mg/kg) ta' piż tal-ġisem SC
English: In a second double-blind study, 262 patients without VTE disease and undergoing hip replacement surgery 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=131) once a day SC or to placebo (n=131) for 3 weeks.
Maltese: li kienu 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=131) darba kuljum SC jew għal plaċebo (n=131) għal 3 ġimgħat.
English: injection.
Maltese: trattament.
English: LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg)/0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection
Maltese: mL soluzzjoni għall-injezzjoni - LOVENOX (u ismijiet assoċjati) 6,000 UI (60 mg)/0.6 mL soluzzjoni għall-injezzjoni - LOVENOX (u ismijiet assoċjati) 8,000 UI (80 mg)/0.8 mL soluzzjoni għall-injezzjoni - LOVENOX (u ismijiet assoċjati) 10,000 UI (100 mg)/1 mL soluzzjoni għall-injezzjoni
English: This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions).
Maltese: Dan iwassal għal differenzi fil-farmakokinetika u fl-attivitajiet bijoloġiċi assoċjati magħhom (eż. l-attività kontra t-trombin, u l interazzjonijiet mal-plejtlits).
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
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: Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Maltese: normal saline (0.9%) jew 5% dextrose fl-ilma) kif ġej:
English: • Prevention of thrombus formation in extra corporeal circulation during haemodialysis.
Maltese: • Traċċabilità LMWHs huma prodotti mediċinali bijoloġiċi.
English: Blood and the lymphatic system disorders
Maltese: Disturbi fid-demm u fis-sistema limfatika
English: Following repeated SC administration no accumulation takes place.
Maltese: SC sa madwar 7 sigħat wara għoti ta' dożi ripetuti.
English: A linear relationship between anti-Xa plasma clearance and creatinine clearance at steady-state has been observed, which indicates decreased clearance of enoxaparin sodium in patients with reduced renal function.
Maltese: Kienet osservata relazzjoni lineari bejn tneħħija ta' anti-Xa mill-plażma u teħħija tal-kreatinina fl-istat fiss, li turi tnaqqis fit-tneħħija ta' enoxaparin sodium f'pazjenti b'funzjoni tal-kliewi mnaqqsa.
English: Weight
Maltese: PINNA
English: After repeated SC 150 IU/kg (1.5 mg/kg) once daily dosing, mean AUC of anti-Xa activity is marginally higher at steady state in obese healthy volunteers (BMI 30-48 kg/m2) compared to nonobese control subjects, while maximum plasma anti-Xa activity level is not increased.
Maltese: SC darba kuljum, il-medja tal-AUC tal-attività anti-Xa hija ftit ogħla fl-istat fiss f'voluntiera f'saħħihom b'ħafna piż żejjed (BMI 30-48 kg/m2) meta mqabbla ma' individwi bħala kontroll li ma kellhomx piż żejjed, filwaqt li l-livell tal-attività massima anti-Xa filplażma ma jiżdiedx.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX 10,000 IU/10 mL (100 mg/10 mL) VIAL
Maltese: KAXXA TA' BARRA KUNJETT TA' 10,000 UI/10 mL (100 mg/10 mL)
English: NAME OF THE MEDICINAL PRODUCT LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen Enoxaparin STATEMENT OF ACTIVE SUBSTANCE(S) 1 pen contains 3.0 mL corresponding to 10 single doses of 4,000 IU (40 mg) enoxaparin sodium.
Maltese: Pinna waħda fiha 3.0 mL li huma ekwivalenti għal 10 dożi waħdiet ta' 4,000 UI (40 mg) enoxaparin sodium.
English: • LOVENOX (and associated names) can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
Maltese: • LOVENOX (u ismijiet assoċjati) jista' jingħata permezz ta' injezzjoni ġo vina wara ċerti tipi ta' attakk tal-qalb jew operazzjoni.
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,
English: • Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.
Maltese: • Profilassi ta' mard tromboemboliku fil-vini f'pazjenti li jagħmlu operazzjoni u li għandhom riskju moderat u għoli, b'mod partikolari dawk li jkunu qed jagħmlu operazzjonijiet ortopediċi jew ġenerali inkluż operazzjonjiet għall-kanċer.
English: The treatment benefits of enoxaparin sodium, evident for a number of efficacy outcomes, emerged at 48 hours, at which time there was a 35 percent reduction in the relative risk of myocardial reinfarction, as compared with treatment with unfractionated heparin (p<0.001).
Maltese: 48 siegħa, fejn f'dan il-ħin kien hemm tnaqqis ta' 35 fil-mija fir-riskju relattiv ta' infart mijokardijaku mill-ġdid, meta mqabbel ma' trattament b'heparin mhux frazzjonat (p<0.
English: It is recommended to use the LOVENOX formulation without benzyl alcohol in pregnant women.
Maltese: Huwa rrakkomandat li f'nisa tqal tintuża l-formulazzjoni ta' LOVENOX mingħajr benzyl alcohol.
English: Changing of anticoagulant treatment - Changing from LOVENOX (and associated names) to blood thinners called vitamin-K antagonists (e.g. warfarin)
Maltese: - Bidla minn LOVENOX (u ismijiet assoċjati) għal mediċini li jraqqu d-demm imsejħa antagonisti talvitamina K (eż. warfarin)
English: In these patients, careful clinical monitoring is advised, and biological monitoring by anti-Xa activity measurement might be considered (see section 5.2).
Maltese: F'dawn il-pazjenti, huwa rrakkomandat monitoraġġ kliniku b'attenzjoni, u jista' jitqies monitoraġġ bijoloġiku permezz ta' kejl tal-attività anti-Xa (ara sezzjoni 5.2).
English: Subcutaneous, intravenous use.
Maltese: epistassi, u emorraġija gastrointestinali.
English: Although no dose adjustment is recommended in patients with moderate (creatinine clearance 3050 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, careful clinical monitoring is advised.
Maltese: (teħħija tal-kreatinina 30-50 mL/min) u ħafif (teħħija tal-kreatinina 50-80 mL/min) tal-kliewi, huwa rrakomandat monitoraġġ kliniku b'attenzjoni.
English: For the prophylaxis of venous thrombo-embolic disease following surgery, treatment of DVT and PE, treatment of unstable angina and NSTEMI, enoxaparin sodium should be administered by SC injection.
Maltese: Għall-prevenzjoni ta' mard tromboemboliku fil-vini wara operazzjoni, trattament ta' DVT u PE, trattament ta' anġina mhux stabbi u NSTEMI, enoxaparin sodium jingħata permezz ta' injezzjoni SC.
English: When used as prophylactic treatment, enoxaparin sodium does not significantly affect the aPTT.
Maltese: fir-riskju relattiv favur it-trattament b'enoxaparin sodium.
English: Multiple dose vials containing benzyl alcohol:
Maltese: Kunjett b'ħafna dożi li fih benzyl alcohol:
English: • An initial dose of 3,000 IU (30 mg) of LOVENOX (and associated names) will be given as injection into your vein.
Maltese: • Doża tal-bidu ta' 3,000 UI (30 mg) ta' LOVENOX (u ismijiet assoċjati) se tingħata bħala injezzjoni fil-vina tiegħek.
English: Uncommon: Thrombocytopen ia
Maltese: Komuni ħafna: Tromboċitożi β
English: Operation or periods of limited mobility due to an illness
Maltese: Operazzjoni jew perjodu ta' mobilità limitata minħabba mard
English: Multiple dose vials containing benzyl alcohol
Maltese: Kunjetti b'ħafna dożi li fihom benzyl alcohol
English: The safety and efficacy of enoxaparin sodium in paediatric population have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' enoxaparin sodium fil-popolazzjoni pedjatrika ma ġewx determinati s'issa.
English: - cramping pain, redness, warmth, or swelling in one of your legs - these are symptoms of deep vein thrombosis - breathlessness, chest pain, fainting or coughing up blood - these are symptoms of a pulmonary embolism
Maltese: - qtugħ ta' nifs, uġigħ fis-sider, ħass ħażin jew tisgħol id-demm - dawn huma sintomi ta' emboliżmu fil-pulmuni
English: Thrombocytopenia and thrombocytosis System
Maltese: Tromboċitopenija u tromboċitożi
English: LOVENOX (and associated names) can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI).
Maltese: (infart mijokardijaku b'elevazzjoni fis-segment ST - ST segment elevation myocardial infarction) jew Non
English: SC administration was given more than 8 hours before balloon inflation, an IV bolus of 30 IU/kg (0.3 mg/kg) enoxaparin sodium should be administered.
Maltese: Jekk l-aħħar għoti SC ingħata aktar minn 8 sigħat qabel intefħet il bużżieqa, għandha tingħata doża f'daqqa IV ta' 30 UI/kg (0.3 mg/kg) enoxaparin sodium.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Maltese: • Pazjenti b'ħafna Piż Żejjed
English: • The maximum amount of LOVENOX (and associated names) given for the first two injections is 7,500 IU (75 mg).
Maltese: • L-ammont massimu ta' LOVENOX (u ismijiet assoċjati) mogħti għall-ewwel żewġ injezzjonijiet jkun 7,500 UI (75 mg).
English: In these patients, careful clinical monitoring is advised, and biological monitoring by anti-Xa activity measurement might be considered (see sections 4.2 and 5.2).
Maltese: F'dawn il-pazjenti, huwa rrakkomandat monitoraġġ kliniku b'attenzjoni, u jista' jitqies monitoraġġ bijoloġiku permezz ta' kejl tal-attività anti-Xa (ara sezzjonijiet 4.2 u 5.2)
English: Benzyl alcohol may also cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old (see section 4.4).
Maltese: Benzyl alcohol jista' jikkawża wkoll reazzjonijiet tossiċi u reazzjoniijiet anafilaktojd fit-trabi u t-tfal sa 3 snin. 4.5
English: All Treated DVT Patients with or without PE Total VTE (%)
Maltese: Total ta' VTE Total ta' DVT (%) DVT Prossimali (%)
English: 6.1 List of excipients [To be completed nationally]
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti [Biex timtela mill-pajjiż partikolari]
English: LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg /0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection 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: mL soluzzjoni għall-injezzjoni LOVENOX (u ismijiet assoċjati) 6,000 UI (60 mg)/0.6 mL soluzzjoni għall-injezzjoni LOVENOX (u ismijiet assoċjati) 8,000 UI (80 mg)/0.8 mL soluzzjoni għall-injezzjoni LOVENOX (u ismijiet assoċjati) 10,000 UI (100 mg)/1 mL soluzzjoni għall-injezzjoni 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: This medicinal product is authorised in the Member States of the EEA under the following names: {Name of the Member State} {Name of the medicinal product} {Name of the Member State} {Name of the medicinal product} [See Annex I - To be completed nationally] [For referral procedures, as appropriate] This leaflet was last revised in {MM/YYYY} {month YYYY}.
Maltese: {Isem tal-Istat Membru} {Isem tal-prodott mediċinali} {Isem tal-Istat Membru} {Isem tal-prodott mediċinali} [Ara Anness I - Biex timtela mill-pajjiż partikolari] [For referral procedures, as appropriate] Dan il-fuljett kien rivedut l-aħħar f'{XX/SSSS} {xahar SSSS}.
English: Prophylaxis in surgical patients
Maltese: Profilassi Estiża
English: One vial contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 10 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 100 mg) f'10 mL ilma għall-injezzjonijiet.
English: • Extended prophylaxis of venous thromboembolism (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
English: How to store LOVENOX (and associated names) Contents of the pack and other information
Maltese: Kif taħżen LOVENOX (u ismijiet assoċjati) Kontenut tal-pakkett u informazzjoni oħra
English: Your doctor should discuss this with you.
Maltese: Trattament ta' DVT u PE
English: Thrombocytosisβ Thrombocytopen ia
Maltese: Rari ħafna: Tromboċitopen ija immunoallerġi ka
English: Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4).
Maltese: Globalment, id-dejta tissuġġerixxi li ma hemm l-ebda xhieda ta' żieda fir-riskju ta' emorraġija, tromboċitopenija jew osteoporożi rigward ir-riskju osservat f'nisa mhux tqal, ħlief dak osservat f'nisa tqal b'valvi postetiċi tal qalb (ara sezzjoni 4.4).
English: PE, treatment of unstable angina and NSTEMI, enoxaparin sodium is administered by SC
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] enoxaparin sodium
English: • For the prophylaxis of venous thrombo-embolic disease following surgery, treatment of DVT and
Maltese: • Trattament ta' trombożi fil-vini fil-fond (DVT - deep vein thrombosis) u emboliżmu fil-vini (PE
English: As with other anticoagulants, haemorrhage may occur in the presence of associated risk factors such as: organic lesions liable to bleed, invasive procedures or the concomitant use of medications affecting haemostasis (see sections 4.4 and 4.5).
Maltese: Bħal ma jiġri b'antikoagulanti oħra, tista' sseħħ emorraġija fil-preżenza ta' fatturi ta' riskju assoċjati bħal: feriti organiċi li jistgħu jinfasdu, proċeduri invażivi jew l-użu flimkien ma' mediċini li jaffettwaw l emostasi (ara sezzjonijiet 4.4 u 4.5).
English: (numbness or weakness in lower limbs), bowel and/or bladder dysfunction.
Maltese: (bħal insuffiċjenza akuta tal-qalb, insuffiċjenza respiratorja, infezzjonijiet severi jew mard rewmatiku)
English: Concomitant use with caution: The following medicinal products may be administered with caution concomitantly with enoxaparin sodium:
Maltese: • F'pazjenti b'riskju moderat ta' tromboemboliżmu, id-doża rrakkomandata ta' enoxaparin sodium hija
English: • LOVENOX (and associated names) is added to the tube leaving the body (arterial line) at the start of the dialysis session.
Maltese: • LOVENOX (u ismijiet assoċjati) jiżdied mat-tubu li ħiereġ mill-ġisem (pajp irqiq tal-arterja) fil bidu tas-sessjoni tad-dijalisi.
English: Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism.
Maltese: Pazjenti b'ħafna piż żejjed jkunu f'riskju akbar ta' tromboemboliżmu.
English: LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL solution for injection [See Annex I - To be completed nationally]
Maltese: LOVENOX (u ismijiet assoċjati) 10,000 UI (100 mg)/1 mL soluzzjoni għall-injezzjoni
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10,000 IU/10 mL (100 mg/10 mL) VIAL
Maltese: KUNJETT TA' 10,000 UI/10 mL (100 mg/10 mL)
English: Musculoskeletal, connective tissue and bone disorders • Rare: Osteoporosis* following long term therapy (greater than 3 months)
Maltese: Osteoporożi* wara terapija fit-tul (aktar minn 3 xhur)
English: Each prefilled syringe contains enoxaparin sodium 15,000 IU anti-Xa activity (equivalent to 150 mg) in 1.0 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 150 mg) f'1.0 mL ilma għall-injezzjonijiet.
English: The efficacy data are provided in the table below.
Maltese: Id-dejta ta' effikaċja hija pprovduta fit-tabella taħt.
English: After repeated SC administration of the 100 IU/kg (1 mg/kg) twice daily regimen, the steady-state is reached from day 3 to 4 with mean exposure about 65% higher than after a single dose and mean maximum and trough anti-Xa activity levels of about 1.2 and 0.52 IU/mL, respectively.
Maltese: darbtejn kuljum, l-istat fiss jintlaħaq mill-jum 3 sal jum 4 b'esponiment medju madwar 65% aktar milli wara doża waħda u b'medja tal-ogħla u l-inqas livelli ta' attività anti-Xa ta' madwar 1.2 u 0.52 UI/mL, rispettivament.