FrancophonIA/ELRC3.0 huggingface dataset:
English: Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.
Maltese: Livelli anti-Xa xorta jkunu jistgħu jitkejlu f'dawn il-punti ta' ħin, u dan id-dewmien mhuwiex garanzija li ematoma newrassjali se tiġi evitata.
English: • Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
Maltese: • Prednisolone, dexamethasone jew mediċini oħra użati biex jittrattaw l-ażma, l-artrite rewmatojd, u kundizzjonijiet oħra
English: lume to be injected through IV line after dilution is completed at a concentration of 300 IU (3 mg) /mL.
Maltese: Il-volum li għandu jiġi injettat mill-pajp irqiq IV wara li titlesta d-dilwizzjoni b'konċentrazzjoni ta' 300 IU (3 mg) /mL.
English: Headache.
Maltese: FEJN MA
English: These include ATIII-dependent inhibition of other coagulation factors like factor VIIa, induction of endogenous Tissue Factor Pathway Inhibitor (TFPI) release as well as a reduced release of von Willebrand factor (vWF) from the vascular endothelium into the blood circulation.
Maltese: Dawn jinkludu inibizzjoni dipendenti fuq ATIII ta' fatturi ta' koagulazzjoni oħra bħall-fattur VIIa, induzzjoni tar-rilaxx tal-Inibitur tas-Sensiela ta' Reazzjonijiet tal-Fattur tat-Tessut (TFPI, Tissue Factor Pathway Inhibitor) endoġenu kif ukoll tnaqqis fir-rilaxx tal-fattur von Willebrand (vWF, von Willebrand factor) mill-endotelju vaskulari għal ġoċ-ċirkulazzjoni tad-demm.
English: Thorinane 6,000 IU (60 mg)/0.6 mL injection enoxaparin sodium
Maltese: Thorinane 6,000 IU (60 mg)/0.6 mL soluzzjoni għall-injezzjoni enoxaparin
English: No difference in major bleeding was found between the enoxaparin sodium and the placebo group.
Maltese: Ma nstabet l-ebda differenza fi fsada maġġuri bejn il-grupp ta' enoxaparin sodium u l-grupp ta' plaċebo.
English: • Dextran injection - used as a blood replacer
Maltese: • Injezzjoni ta' dextran - użata biex tieħu post id-demm
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
English: • Acute coronary syndrome: - Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
Maltese: - Trattament ta' anġina mhux stabbli u infart mijokardijaku mingħajr elevazzjoni tas-segment ST (NSTEMI - Non ST-segment elevation myocardial infarction), flimkien ma' acetylsalicylic acid mill-ħalq.
English: Following repeated SC administration no accumulation takes place.
Maltese: Wara għoti ripetut SC ma sseħħ l-ebda akkumulazzjoni.
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 se jagħmlu operazzjoni u li għandhom riskju moderat jew għoli, b'mod partikolari dawk li jkunu qed jagħmlu operazzjonijiet ortopediċi jew ġenerali inkluż operazzjonjiet għall-kanċer.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA/I)
English: • In patients at high risk of thromboembolism, the recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily given by SC injection preferably started 12 hours before surgery.
Maltese: • F'pazjenti b'riskju għoli ta' tromboemboliżmu, id-doża rrakkomandata ta' enoxaparin sodium hija 4,000 UI (40 mg) darba kuljum mogħtija permezz ta' injezzjoni SC li preferibbilment tinbeda 12-il siegħa qabel l-operazzjoni.
English: Thorinane 8,000 IU (80 mg)/0.8 mL injection enoxaparin sodium
Maltese: Thorinane 8,000 IU (80 mg)/0.8 mL soluzzjoni għall-injezzjoni Enoxaparin
English: • Bleeding.
Maltese: Nixxifhom.
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: Għalkemm ma huwa rrakkomandat l-ebda aġġustament fid-doża ta' pazjenti b'indeboliment moderat (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: • General
Maltese: A.
English: Thorinane 2,000 IU (20 mg)/0.2 mL injection enoxaparin sodium
Maltese: Informazzjoni għall-utent Thorinane 2,000 IU (20 mg)/0.2 mL soluzzjoni għall-injezzjoni enoxaparin sodium
English: 100 IU/kg (1 mg/kg) body weight SC once daily
Maltese: UI/kg (1 mg/kg) ta' piż tal-ġisem SC darba
English: Immuno-allergic thrombocytopeni a
Maltese: Disturbi fiddemm u fissistema limfatik a
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 kull 24 siegħa
English: dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day.
Maltese: UI, 100 UI/kg u 150 UI/kg (20 mg, 40 mg, 1 mg/kg u 1.5 mg/kg), rispettivament.
English: • Medicines which increase potassium level in your blood such as potassium salts, water pills, some medicines for heart problems.
Maltese: • Medicines li jżidu l-livell tal-potassium fid-demm tiegħek bħal melħ tal-potassium, pilloli tal‘pipi', xi mediċini għal problemi tal-qalb.
English: The 3,000 IU (30 mg) dose can then be directly injected into the IV line.
Maltese: Id-doża ta' 3,000 UI (30 mg) tista' imbagħad tiġi injettata direttament fil-pajp irqiq IV.
English: Oral anticoagulant therapy should be initiated when appropriate (see “Switch between enoxaparin sodium and oral anticoagulants” at the end of section 4.2).
Maltese: Terapija antikoagulanti mill-ħalq għandha tinbeda fejn ikun xieraq (ara “Bidla bejn enoxaparin sodium u antikoagulanti mill-ħalq” fi tmiem is-sezzjoni 4.2).
English: • Haemorrhage
Maltese: • Ġenerali
English: Retroperitoneal haemorrhage
Maltese: Tromboċitope nija
English: Paediatric population 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: 9) Drop the used syringe with its protective sleeve into the sharps bin provided.
Maltese: 9) Iwaqqaf tagħqid tad-demm li diġà jeżisti milli jkompli jikber.
English: 0.6 mL of solution in a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and an orange polypropylene plunger rod.
Maltese: 0.6 mL ta' soluzzjoni f'bettija tas-siringa ggradata ta' ħġieġ newtrali ċar, mingħajr kulur tat-tip I b'labra mwaħħla u għatu tal-labra magħluq b'tapp tal-gomma tal-chlorobutyl u virga tal-planġer ta' polypropylene oranġjo.
English: Each prefilled syringe contains enoxaparin sodium 6,000 IU anti-Xa activity (equivalent to 60 mg) in 0.6 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 60 mg) f'0.6 mL ilma għall-injezzjonijiet.
English: th and the 21
Maltese: UI, 4,000
English: SC injection.
Maltese: Armi t-tapp.
English: After repeated SC administration of 4,000 IU (40 mg) once daily and 150 IU/kg (1.5 mg/kg) once daily regimens in healthy volunteers, the steady-state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose.
Maltese: Wara skedi ta' għoti ripetut SC ta' 4,000 UI (40 mg) darba kuljum u 150 UI/kg (1.5 mg/kg) darba kuljum f'voluntiera f'saħħithom, l-istat fiss jintlaħaq biss f'jum 2 bi proporzjon ta' esponiment medju ta' madwar 15% aktar milli wara doża waħda.
English: Enoxaparin sodium compared to unfractionated heparin significantly decreased the incidence of the primary end point, a composite of death from any cause or myocardial re-infarction in the first 30 days after randomization [9.9 percent in the enoxaparin sodium group, as compared with 12.0 percent in the unfractionated heparin group] with a 17 percent relative risk reduction (p<0.001).
Maltese: Enoxaparin sodium meta mqabbel ma' heparin mhux frazzjonat naqqas b'mod sinifikanti l-inċidenza taliskop finali prmarju, kompost ta' mewt minn kull kawża jew infart mijokardijaku mill-ġdid fl-ewwel 30 jum wara l-għażla b'mod arbitrarju [9.9 fil-mija fil-grupp ta' enoxaparin sodium, meta mqabbel ma' 12.0 fil-mija fil-grupp ta' heparin mhux frazzjonat] bi 17 fil-mija ta' tnaqqis fil-perċentwal tar-riskju relattiv (p<0.
English: • Rare: Cases of immuno-allergic thrombocytopenia with thrombosis; in some of them thrombosis was complicated by organ infarction or limb ischaemia (see section 4.4).
Maltese: Każijiet ta' tromboċitopenija immunoallerġika bi trombożi; f'xi każijiet it-trombożi kienet ikkumplikata b'infart fl-organu jew iskemija fid-driegħ jew fir-riġel (ara sezzjoni 4.4).
English: Heparins can suppress adrenal secretion of aldosterone leading to hyperkalaemia (see section 4.8), particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, taking medicinal products known to increase potassium (see section 4.5).
Maltese: Il-heparins jistgħu jissoppressaw is-sekrezzjoni ta' aldosterone mill-glandoli adrenali li jwassal għal iperkalimja (ara sezzjoni 4.8), b'mod partikolari f'pazjenti bħal dawk bid-dijabete mellitus, insuffiċjenza kronika tal-kliewi, aċidożi metabolika diġà eżistenti, teħid ta' prodotti mediċinali magħrufa li jżidu lpotassium (ara sezzjoni 4.5).
English: Enoxaparin sodium can be administered SC either as a once daily injection of 150 IU/kg (1.5 mg/kg) or as twice daily injections of 100 IU/kg (1 mg/kg).
Maltese: Enoxaparin sodium jista' jingħata SC jew bħala injezzjoni darba kuljum ta' 150 UI/kg (1.5 mg/kg) jew inkella bħala injezzjonijiet darbtejn kuljum ta' 100 UI/kg (1 mg/kg).
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: Madankollu, anke b'dożi għoljin ta' 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: - concomitant use of medications affecting haemostasis (see section 4.5).
Maltese: - l-użu flimkien ta' mediċini li jaffettwaw l-emostasi (ara sezzjoni 4.5).
English: One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium
Maltese: Siringa waħda mimlija għal-lest (1 mL) fiha 10,000 UI (100 mg) enoxaparin sodium
English: Treatment continued for 6 to 14 days (median duration 7 days).
Maltese: It-trattament kompla għal 6 sa 14-il jum (tul ta' żmien medjan ta' 7 ijem).
English: Thrombocytopenia and thrombocytosis
Maltese: Użu fit-tfal u fl-adolexxenti
English: • you have endocarditis (an infection of the inner lining of the heart)
Maltese: • inti għadek endokartite (infezzjoni tal-inforra ta' ġewwa tal-qalb) • inti għandek storja ta' ulċera fl-istonku
English: At approximately 3 months following enrolment, the incidence of VTE remained significantly lower in the enoxaparin sodium 4,000 IU (40 mg) treatment group versus the placebo treatment group.
Maltese: Madwar 3 xhur minn meta ġew irreġistrat fl-istudju, l-inċidenza ta' VTE baqgħet aktar baxxa b'mod sinifikanti fil-grupp ta' trattament b'enoxaparin sodium 4,000 UI (40 mg) versus il-grupp ta' trattament bil-plaċebo.
English: Packs of 2 and 10 pre-filled syringes.
Maltese: Pakketti ta' 2 jew 10 siringi mimlija għal-lest.
English: No pharmacokinetic interactions were observed between enoxaparin sodium and thrombolytics when administered concomitantly.
Maltese: Ma kienu osservati l-ebda interazzjonijiet farmakokinetiċi bejn enoxaparin sodium u trombolitiċi meta dawn ingħataw flimkien.
English: 4,716 patients underwent percutaneous coronary intervention receiving antithrombotic support with blinded study drug.
Maltese: 4,716 il-pazjent għamlu intervent koronarju perkutanju waqt li rċivew sostenn antitrombotiku mingħajr ma kienu jafu liema kienet il-mediċina tal-istudju.
English: Thorinane 2,000 IU (20 mg)/0.2 mL
Maltese: IU (20 mg)/0.2 mL
English: One pre-filled syringe (0.2 mL) contains 2,000 IU (20 mg) enoxaparin sodium
Maltese: Siringa waħda mimlija għal-lest (0.2 mL) fiha 2,000 UI (20 mg) enoxaparin sodium
English: Treatment of DVT and PE
Maltese: Trattament b'DVT b'PE jew mingħajru
English: Haemodialysis
Maltese: Emorraġiji
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: 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. Lesponiment 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: • Stop blood clots forming in the tubes of your dialysis machine (used for people with severe kidney problems).
Maltese: • Iwaqqaf tagħqid tad-demm milli jifforma fit-tubi tal-magna tad-dijalisi tiegħek (użata għal persuni bi problemi severi tal-kliewi).
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: Wara għoti ripetut SC tal-iskeda ta' għoti ta' 100 UI/kg (1 mg/kg) 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.
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 non-obese 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: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Thorinane 8,000 IU (80 mg)/0.8 mL solution for injection enoxaparin sodium
Maltese: Thorinane 8,000 IU (80 mg)/0.8 mL soluzzjoni għall-injezzjoni enoxaparin
English: st day following the beginning of enoxaparin sodium treatment.
Maltese: u l-21 jum wara l-bidu ta' trattament b'enoxaparin sodium.
English: • Hyperkalaemia
Maltese: Il-Greċja
English: Thorinane contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) għal kull doża, jiġifieri hi essenzjalment “ħielsa mis-sodium”.
English: For dosage in elderly patients with impaired kidney function, see below “renal impairment” and section 4.4.
Maltese: Għall-għoti tad-doża f'pazjenti anzjani b'indeboliment fil-funzjoni tal-kliewi, ara taħt “indeboliment tal-kliewi” u sezzjoni 4.4.
English: Enoxaparin sodium treatment is prescribed for an average period of 10 days.
Maltese: Trattament b'enoxaparin sodium jiġi ordnat b'riċetta għal perjodu medju ta' 10 ijiem.
English: Each prefilled syringe contains enoxaparin sodium 4,000 IU anti-Xa activity (equivalent to 40 mg) in 0.4 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 40 mg) f'0.4 mL ilma għall-injezzjonijiet.
English: 0.8 mL of solution in a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a red polypropylene plunger rod.
Maltese: 0.8 mL ta' soluzzjoni f'bettija tas-siringa ta' ħġieġ newtrali ċar, mingħajr kulur tat-tip I b'labra mwaħħla u għatu tal-labra magħluq b'tapp tal-gomma tal-chlorobutyl u virga tal-planġer ta' polypropylene iswed.
English: The benefit is not established for a treatment longer than 14 days.
Maltese: Mhuwiex stabbilit il-benefiċċju għal trattament itwal minn 14-il jum.
English: Studies conducted in pregnant rats and rabbits at SC doses of enoxaparin sodium up to 30 mg/kg/day did not reveal any evidence of teratogenic effects or foetotoxicity.
Maltese: Studji li saru f'firien u fniek tqal b'dożi ta' enoxaparin sodium SC sa 30 mg/kg/jum ma wrew l-ebda evidenza ta' effetti teratoġeniċi jew effett tossiku fuq il-fetu.
English: EXP
Maltese: Piż
English: Changing of anticoagulant treatment - Changing from Thorinane to blood thinners called vitamin-K antagonists (e.g. warfarin) Your doctor will request you perform blood tests called INR and tell you when to stop Thorinane accordingly.
Maltese: Bidla tat-trattament antikoagulanti - Bidla minn Thorinanegħal mediċini li jraqqu d-demm imsejħa antagonisti tal-vitamina K (eż.
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-profilassi ta' mard tromboemboliku fil-vini wara operazzjoni, trattament ta' DVT u PE, trattament ta' anġina mhux stabbi u NSTEMI, enoxaparin sodium għandu jingħata permezz ta' injezzjoni SC.
English: Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 20 mg) f'0.2 mL ilma għall-injezzjonijiet.
English: Other adverse reactions observed in clinical studies and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below.
Maltese: Reazzjonijiet avversi oħra osservati fi studji kliniċi u rrappurtati f'esperjenza wara t-tqegħid fis-suq (*tindika reazzjonijiet minn esperjenza wara t-tqegħid fis-suq) huma deskritti fid-dettall taħt.
English: One pre-filled syringe (0.4 mL) contains 4,000 IU (40 mg) enoxaparin sodium
Maltese: Siringa waħda mimlija għal-lest (0.4 mL) fiha 4,000 UI (40 mg) enoxaparin sodium
English: • Prevention of thrombus formation in extra corporeal circulation during haemodialysis.
Maltese: • Prevenzjoni ta' formazzjoni ta' trombus fiċ-ċirkulazzjoni barra mill-ġisem waqt l-emodijalisi.
English: Blood and the lymphatic system disorders
Maltese: Disturbi fiddemm u fissistema limfatika
English: • Stop blood clots from forming in your blood in the following situations: o When you have an acute illness and face period of limited mobility o When you have unstable angina (a condition when not enough blood gets to your heart)
Maltese: • Iwaqqaf tagħqid tad-demm milli jifforma fid-demm tiegħek fis-sitwazzjonijiet li ġejjin: o Meta inti jkollok mard akut u taffaċċja perjodu ta' mobilità limitata o Meta jkollok anġina mhux stabbli (kondizzjoni fejn ma jasalx biżżejjed demm f'qalbek)
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 lemostasi (ara sezzjonijiet 4.4 u 4.5).
English: Thorinane 10,000 IU (100 mg) /1.0 mL injection enoxaparin sodium
Maltese: IU (100 mg)/1.0 mL soluzzjoni għall-injezzjoni enoxaparin sodium
English: If the last 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 ilbużżieqa, għandha tingħata doża f'daqqa IV ta' 30 UI/kg (0.3 mg/kg) enoxaparin sodium.
English: An infusion of 0.5 mg protamine per 100 IU (1 mg) of enoxaparin sodium may be administered if enoxaparin sodium was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required.
Maltese: Infużjoni ta' 0.5 mg protamine għal kull 100 IU (1 mg) ta' enoxaparin sodium tista' tingħata jekk enoxaparin sodium ikun ingħata aktar minn 8 sigħat qabel l-għoti ta' protamine, jew jekk ikun ġie determinat li hija meħtieġa t-tieni doża ta' protamine.
English: Limited data are available in patients with hepatic impairment (see sections 5.1 and 5.2) and caution should be used in these patients (see section 4.4).
Maltese: Hija disponibbli dejta limitata f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 5.1 u 5.2) u għandha tintuża l-kawtela f'dawn il-pazjenti (ara sezzjoni 4.4).
English: • Rare: Spinal haematoma* (or neuraxial haematoma).
Maltese: Ematoma fis-sinsla* (jew ematoma newrassjali).
English: Enoxaparin sodium was found to have no effect on fertility or reproductive performance of male and female rats at SC doses up to 20 mg/kg/day.
Maltese: Enoxaparin sodium nstab li m'għandu l-ebda effett fuq il-fertilità jew il-kapaċità riproduttiva ta' firien irġiel u nisa b'dożi SC sa 20 mg/kg/jum.
English: Enoxaparin sodium is not recommended for patients with end stage renal disease (creatinine clearance <15 mL/min) due to lack of data in this population outside the prevention of thrombus formation in extra corporeal circulation during haemodialysis.
Maltese: Enoxaparin sodium mhuwiex rrakkomandat għal pazjenti b'mard tal-kliewi fl-aħħar stadju (teħħija talkreatinina <15 mL/min) minħabba nuqqas ta' dejta f'din il-popolazzjoni apparti mill-prevenzjoni ta' formazzjoni ta' trombus fiċ-ċirkulazzjoni barra l-ġisem waqt l-emodijalisi.
English: INSTRUCTIONS FOR USE: PREFILLED SYRINGE
Maltese: • Profilassi estiża ta' VTE wara operazzjoni ortopedika
English: Enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day SC n (%)
Maltese: Wara għoti ripetut ta' 150 UI/kg (1.5 mg/kg)
English: Blood and lymphatic system disorders
Maltese: Disturbi fid-demm u fis-sistema limfatika
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: 10,000 UI/mL (100 mg/mL) soluzzjoni għall-injezzjoni 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: An increase in exposure of enoxaparin sodium with prophylactic dosages (non-weight adjusted) has been observed in low-weight women (<45 kg) and low-weight men (<57 kg), which may lead to a higher risk of bleeding.
Maltese: Żieda fl-esponiment għal enoxaparin sodium b'dożi profilattiċi (mhux aġġustati għall-piż) kienet osservata f'nisa b'piż baxx (<45 kg) u irġiel b'piż baxx (<57 kg), li jista' jwassal għal riskju akbar ta' fsada.
English: • Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming (see also in section 3, “Changing of anticoagulant medicine”)
Maltese: • Aspirina (magħrufa wkoll bħala acetylsalicylic acid jew ASA), clopidogrel jew mediċini oħra li jintużaw biex iwaqqfu tagħqid tad-demm milli jifforma (ara wkoll f'sezzjoni 3, “Bidla ta' mediċina antikoagulanti”)
English: - enoxaparin sodium once a day versus heparin (-3.0 to 3.5)
Maltese: 008 #valur p versus plaċebo =0.537