FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhixa 10,000 IU (100 mg)/1 mL
Maltese: IU (100 mg)/1 mL
English: Although 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, 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: 100 IU/kg (1 mg/kg) body weight SC once daily
Maltese: UI/kg (1 mg/kg) ta' piż tal-ġisem SC darba kuljum
English: In a double blind multicentre, parallel group study, enoxaparin sodium 2,000 IU (20 mg) or 4,000 IU (40 mg) once a day subcutaneously 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 taħt ilġilda 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: Enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day subcutaneously n (%)
Maltese: Enoxaparin sodium 150 UI/kg (1.5 mg/kg) darba kuljum taħt il-ġilda n (%)
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 tal-kreatinina <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: 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: Wara għoti ripetut ta' 150 UI/kg (1.5 mg/kg) taħt il-ġilda darba kuljum, il-medja tal-AUC tal-attività antiXa 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: Benzyl alcohol (see leaflet for further information) Water for injections
Maltese: Alkoħol benżiliku (ara l-fuljett għal aktar informazzjoni)
English: - Changing from Inhixa to treatment with direct oral anticoagulant Stop taking Inhixa.
Maltese: - Bidla minn Inhixagħal trattament b'antikoagulant orali dirett Waqqaf Inhixa.
English: • Acetylsalicylic acid (ASA), clopidogrel or other medicines used to stop blood clots from forming (see also section 3, “Changing of anticoagulant medicine”)
Maltese: • Acetylsalicylic acid (ASA), clopidogrel jew mediċini oħra li jintużaw biex iwaqqfu tagħqid tad-demm milli jifforma (ara wkoll sezzjoni 3, “Bidla ta' mediċina antikoagulanti”)
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 =< 0.001).
English: Treatment of DVT and PE
Maltese: Trattament ta' DVT u PE
English: Uncommon: Thrombocytop enia
Maltese: Mhux komuni: Tromboċitopenija
English: Inhixa 2,000 IU (20 mg)/0.2 mL
Maltese: IU (20 mg)/0.2 mL
English: Immunoallergic thrombocytope nia
Maltese: Rari ħafna: Tromboċitopen ija immunoallerġi ka
English: All Treated Extended Prophylaxis Patients
Maltese: Bid-dożi użati għall-profilassi
English: 5 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and grey aluminium-plastic cap in a cardboard box.
Maltese: 5 mL ta' soluzzjoni f'kunjett ta' ħġieġ ċar, mingħajr kulur tat-tip I issiġillat b'tapp tal-injezzjoni tal-gomma u kappa griża tal-aluminju-plastik f'kaxxa tal-kartun.
English: Switch between enoxaparin sodium and oral anticoagulants Switch between enoxaparin sodium and vitamin K antagonists (VKA) Clinical monitoring and laboratory tests [prothrombin time expressed as the International Normalized Ratio (INR)] must be intensified to monitor the effect of VKA.
Maltese: Bidla bejn enoxaparin sodium u antagonisti tal-vitamina K (VKA - vitamin K antagonists) Il-monitoraġġ kliniku u t-testijiet tal-laboratorju [ħin tal-protrombin espress bħala l-Proporzjon Normalizzat Internazzjonali (INR - International Normalized Ratio)] għandhom jiġu intensifikati biex jiġi mmonitorjat l-effett ta' VKA.
English: Supplied in packs of 1 and 5 vials.
Maltese: Fornuti f'pakketti ta' 1 jew 5 kunjetti.
English: IV (Bolus) Injection (for acute STEMI indication only):
Maltese: Injezzjoni fil-vini (f'daqqa) (għall-indikazzjoni ta' STEMI akut biss):
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: Enoxaparin sodium 100 IU/kg (1 mg/kg) twice a day subcutaneously n (%)
Maltese: Enoxaparin sodium 100 UI/kg (1 mg/kg) darbtejn kuljum taħt il-ġilda n (%)
English: CARTON OF (Packs of 2, 6, 10, 12, 20, 24 or 30)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ L-IMBALLAĠĠ ESTERN KARTUNA TA' (Pakketti ta' 2, 6, 10, 12, 20, 24 jew 30)
English: 2 pre-filled syringes with needle guard 5 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 50 pre-filled syringes with needle guard 90 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 6 pre-filled syringes with UltraSafe Passive needle guard
Maltese: 2 siringi mimlijin għal-lest b'ilqugħ għal-labra 5 siringi mimlijin għal-lest b'ilqugħ għal-labra 6 siringi mimlijin għal-lest b'ilqugħ għal-labra 10 siringi mimlijin għal-lest b'ilqugħ għal-labra 20 siringi mimlijin għal-lest b'ilqugħ għal-labra 30 siringi mimlijin għal-lest b'ilqugħ għal-labra 50 siringi mimlijin għal-lest b'ilqugħ għal-labra 90 siringi mimlijin għal-lest b'ilqugħ għal-labra 2 siringi mimlijin għal-lest UltraSafe Passive b'ilqugħ għal-labra 6 siringi mimlijin għal-lest UltraSafe Passive b'ilqugħ għal-labra
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: EU/1/16/1132/069 EU/1/16/1132/073 EU/1/16/1132/075 EU/1/16/1132/076 EU/1/16/1132/077
Maltese: EU/1/16/1132/069 EU/1/16/1132/073 EU/1/16/1132/075 EU/1/16/1132/076
English: • Your doctor will normally ask you to take acetylsalicylic acid as well.
Maltese: • It-tabib tiegħek normalment jgħidlek tieħu acetylsalicylic acid ukoll.
English: One vial contains enoxaparin sodium 50,000 IU anti-Xa activity (equivalent to 500 mg) in 5.0 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 500 mg) f'5.0 mL ilma għall-injezzjonijiet.
English: Blood and the lymphatic system disorders o Common: Haemorrhage, haemorrhagic anaemia*, thrombocytopenia, thrombocytosis o Rare: Eosinophilia* o 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: Inhixa 10,000 IU (100 mg) /1 mL injection enoxaparin sodium
Maltese: IU (100 mg)/1 mL soluzzjoni għall-injezzjoni enoxaparin sodium
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: jitqies monitoraġġ bijoloġiku permezz ta' kejl tal-attività anti-Xa (ara sezzjonijiet 4.2 u 5.2)
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 lkateter.
English: • In patients at moderate risk of thromboembolism, the recommended dose of enoxaparin sodium is 2,000 IU (20 mg) once daily by subcutaneous injection.
Maltese: • F'pazjenti b'riskju moderat ta' tromboemboliżmu, id-doża rrakkomandata ta' enoxaparin sodium hija 2,000 UI (20 mg) darba kuljum permezz ta' injezzjoni taħt il-ġilda.
English: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH), to benzyl alcohol or any other 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) jew għal kwalunkwe wieħed milleċċipjenti elenkati fis-sezzjoni 6.1;
English: Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose vial enoxaparin sodium
Maltese: Inhixa 50,000 IU (500 mg)/5 mL soluzzjoni għall-injezzjoni f'kunjett b'ħafna dożi enoxaparin
English: Patients received enoxaparin sodium (4,000 IU (40 mg) subcutaneously) 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) taħt il-ġilda) 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: Packs of: - 2, 5, 6, 10, 30 and 50 pre-filled syringes - 2, 5, 6, 10, 20, 30, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Maltese: Fornuti f'pakketti ta': - 2, 5, 6, 10, 30 u 50 siringi mimlija għal- lest - 2, 5, 6, 10, 20, 30, 50 u 90 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra - 2 u 6 siringi mimlija minn UltraSafe Passive qabel b'tagħmir ta' tarka għal-labra
English: As benzyl alcohol may cross the placenta, it is recommended to use a formulation that does not contain benzyl alcohol.
Maltese: Peress li alkoħol benżiliku jista' jgħaddi mill-plaċenta, huwa rrakkomandat li tintuża formulazzjoni li ma jkunx fiha alkoħol benżiliku.
English: Percutaneous coronary revascularization procedures
Maltese: Proċeduri ta' rivaskularizzazzjoni koronarja perkutanja
English: To obtain a 300 IU/mL (3 mg/mL) solution, using a 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe, it is recommended to use a 50 mL infusion bag (i.e. using either normal sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose in water for injections) as follows:
Maltese: Biex tikseb soluzzjoni ta' 300 UI/mL (3 mg/mL), bl-użu ta' siringa mimlija għal-lest ta' 6,000 UI (60 mg) enoxaparin sodium, huwa rrakkomandat li tintuża borża tal-infużjoni ta' 50 mL (i.e. tuża jew sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-infużjoni (0.9%) jew 5% glucose fl-ilma għall-injezzjonijiet) kif ġej:
English: • Acetylsalicylic acid is recommended for all patients without contraindications at an initial oral loading dose of 150-300 mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75-325 mg/day long-term regardless of treatment strategy.
Maltese: • Acetylsalicylic acid huwa rrakkomandat għall-pazjenti kollha mingħajr kontraindikazzjonijiet b'doża għolja fil-bidu ta' 150-300 mg (f'pazjenti li qatt ma jkunu ħadu acetylsalicylic acid) mill-ħalq u doża ta' manteniment ta' 75-325 mg/kuljum mill-ħalq għal tul ta' żmien irrispettivament mill-istrateġija ta' trattament.
English: Thrombocytopenia
Maltese: Tromboċitopen ija
English: st day following the beginning of enoxaparin sodium treatment.
Maltese: es u l-21 jum wara l-bidu ta' trattament b'enoxaparin sodium.
English: Inhixa 6,000 IU (60 mg)/0.6 mL solution for injection enoxaparin sodium
Maltese: Inhixa 6,000 IU (60 mg)/0.6 mL soluzzjoni għall-injezzjoni Enoxaparin
English: CARTON (Packs of 1, 2, 6, 10, 20, 50 or 90)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ L-IMBALLAĠĠ ESTERN KARTUNA (Pakketti ta' 1, 2, 6, 10, 20, 50 jew 90)
English: Skin necrosis / cutaneous vasculitis
Maltese: Valvi mekkaniċi prostetiċi tal-qalb
English: In patients with severe renal impairment (creatinine clearance <30 mL/min), the AUC at steady state is significantly increased on average by 65% after repeated SC 4,000 IU (40 mg) once daily doses (see sections 4.2 and 4.4).
Maltese: F'pazjenti b'indeboliment sever tal-kliewi (teħħija tal-kreatinina <30 mL/min), l-AUC fl-istat fiss tiżdied b'mod sinifikanti b'madwar 65% wara dożi ripetuti taħt il-ġilda ta' 4,000 UI (40 mg) darba kuljum (ara sezzjonijiet 4.2 u 4.4).
English: Hepato-biliary disorders o Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality) o Uncommon: Hepatocellular liver injury * o Rare: Cholestatic liver injury*
Maltese: Disturbi fil-fwied u fil-marrara o Komuni ħafna: Żidiet fl-enzimi tal-fwied (l-aktar it-transaminases > 3 darbiet l-ogħla limitu tannormal) o Mhux komuni: Ħsara fil-fwied u fiċ-ċelluli tal-fwied*, o Rari:
English: Inhixa 10,000 IU (100 mg)/1 mL is 1 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 black polypropylene plunger rod.
Maltese: IU (100 mg)/1 mL huwa 1 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: Inhixa 12,000 IU (120 mg)/0.8 mL solution for injection Inhixa 15,000 IU (150 mg)/1 mL solution for injection enoxaparin sodium
Maltese: IU (120 mg)/0.8 mL soluzzjoni għall-injezzjoni Inhixa 15,000
English: • Rare: Anaphylactic/Anaphylactoid reactions including shock*
Maltese: Komuni: Reazzjoni allerġika Rari: Reazzjonijiet anafilattiċi/anafilaktojd inkluż xokk*
English: Do not inject Inhixa into a muscle.
Maltese: Tinjettax Inhixa ġo muskolu.
English: In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day.
Maltese: Fit-trattament ta' DVT b'PE jew mingħajru, pazjenti li kienu qed jirċievu enoxaparin sodium ġew ittrattati b'doża ta' 100 UI/kg (1 mg/kg) SC kull 12-il siegħa jew doża ta' 150 UI/kg (1.5 mg/kg) SC darba kuljum.
English: A 3,000 IU (30 mg) intravenous bolus immediately followed by a 100 IU/kg (1 mg/kg) subcutaneous every 12 hours provided initial maximum anti-Xa activity level of 1.16 IU/mL (n=16) and average exposure corresponding to 88% of steady-state levels.
Maltese: Injezzjoni ta' 3,000 UI (30 mg) f'daqqa fil-vini segwita immedjatament minn 100 UI/kg (1 mg/kg) taħt ilġilda kull 12-il siegħa pprovdiet livell inizjali ta' attività massima anti-Xa ta' 1.16 UI/mL (n = 16) u esponiment medju li jaqbel ma' 88% tal-livelli fl-istat fiss.
English: Immune system disorders • Common: Allergic reaction
Maltese: Tromboċitopenija Rari ħafna: Tromboċitopenija immunoallerġika
English: Treatment of unstable angina and NSTEMI 100 IU/kg (1 mg/kg) body weight SC once daily
Maltese: Trattament ta' anġina mhux stabbli u NSTEMI 100 UI/kg (1 mg/kg) ta' piż tal-ġisem SC darba kuljum
English: A 3,000 IU (30 mg) intravenous bolus immediately followed by a 100 IU/kg (1 mg/kg) subcutaneously every 12 hours provided initial maximum anti-Xa activity level of 1.16 IU/mL (n = 16) and average exposure corresponding to 88% of steady-state levels.
Maltese: Injezzjoni ta' 3,000 UI (30 mg) f'daqqa fil-vini segwita immedjatament minn 100 UI/kg (1 mg/kg) taħt ilġilda kull 12-il siegħa pprovdiet livell inizjali ta' attività massima anti-Xa ta' 1.16 UI/mL (n=16) u esponiment medju li jaqbel ma' 88% tal-livelli fl-istat fiss.
English: Volume 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: Thrombocytopenia and thrombocytosis System Organ
Maltese: Tromboċitopenija u tromboċitożi
English: To obtain a 300 IU/mL (3 mg/mL) solution, using a 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe, it is recommended to use a 50 mL infusion bag (i.e. using either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose in water) as follows:
Maltese: Biex tikseb soluzzjoni ta' 300 UI/mL (3 mg/mL), bl-użu ta' siringa mimlija għal-lest ta' 6,000 UI (60 mg) enoxaparin sodium, huwa rrakkomandat li tintuża borża tal-infużjoni ta' 50 mL (i.e. tuża sodium chloride 9 mg/ml (0.9%) soluzzjoni għal infużjoni jew 5% dextrose fl-ilma) kif ġej:
English: EU/1/16/1132/005 EU/1/16/1132/006 EU/1/16/1132/015 EU/1/16/1132/016 EU/1/16/1132/026 EU/1/16/1132/027 EU/1/16/1132/028 EU/1/16/1132/037 EU/1/16/1132/038 EU/1/16/1132/045 EU/1/16/1132/046 EU/1/16/1132/057 EU/1/16/1132/058 EU/1/16/1132/083
Maltese: EU/1/16/1132/038 EU/1/16/1132/016 EU/1/16/1132/026 EU/1/16/1132/027 EU/1/16/1132/028 EU/1/16/1132/046 EU/1/16/1132/057 EU/1/16/1132/058
English: EU/1/16/1132/009 EU/1/16/1132/010 EU/1/16/1132/019 EU/1/16/1132/020 EU/1/16/1132/022 EU/1/16/1132/031 EU/1/16/1132/032 EU/1/16/1132/041 EU/1/16/1132/042 EU/1/16/1132/049 EU/1/16/1132/050 EU/1/16/1132/061 EU/1/16/1132/062 EU/1/16/1132/063
Maltese: EU/1/16/1132/022 EU/1/16/1132/031 EU/1/16/1132/032 EU/1/16/1132/041 EU/1/16/1132/042 EU/1/16/1132/049 EU/1/16/1132/050 EU/1/16/1132/061
English: Intracranial haemorrhage, Retroperitoneal haemorrhage α: such as haematoma, ecchymosis other than at injection site, wound haematoma, haematuria, epistaxis and gastro-intestinal haemorrhage.
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: In moderate risk patients, enoxaparin sodium treatment should be maintained for a minimal period of 7-10 days whatever the recovery status (e.g. mobility).
Maltese: F'pazjenti b'riskju moderat, it-trattament b'enoxaparin sodium għandu jinżamm għal perjodu minimu ta' 7-10 ijiem irrispettivament mill-istat ta' rkupru (eż. mobilità).
English: Changing of anticoagulant treatment - Changing from Inhixa 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 Inhixa accordingly.
Maltese: Bidla tat-trattament antikoagulanti - Bidla minn Inhixagħal mediċini li jraqqu d-demm imsejħa antagonisti tal-vitamina K (eż. warfarin)
English: Severe renal impairment
Maltese: Jekk tieqaf tuża Inhixa
English: Blood and lymphati c system disorders
Maltese: Disturbi fiddemm u fissistema limfatik a
English: Prevention of venous thromboembolic disease associated with surgery 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) subcutaneously, were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n=90) once a day subcutaneously 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: Solution for injection 2 pre-filled syringes 10 pre-filled syringes 30 pre-filled syringes 10 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard
Maltese: Fornuti f'pakketti ta': - 2, 10 jew 30 siringi mimlija għal- lest - 10 jew 30 siringi mimlija għal-lest b'apparat tas-sikurezza tal-labar
English: Do not start treatment with Inhixa until 12 hours after the final dose of direct oral anticoagulant.
Maltese: Tibdiex it-trattament b'Inhixa sa 12-il siegħa wara l-aħħar doża tal-antikoagulant orali dirett.
English: Supplied in packs of 5 vials.
Maltese: Fornuti f'pakketti ta' 5 kunjetti.
English: One pre-filled syringe (1 mL) contains 15,000 IU (150 mg) enoxaparin sodium
Maltese: Siringa waħda mimlija għal-lest (1 mL) fiha 15,000 UI (150 mg) enoxaparin sodium
English: What Inhixa looks like and contents of the pack - 3 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box.
Maltese: 3 mL ta' soluzzjoni f'kunjett ta' ħġieġ ċar, mingħajr kulur tat-tip I issiġillat b'tapp tal-injezzjoni tal-gomma u kappa bajda tal-aluminju-plastik f'kaxxa tal-kartun.
English: 2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 50 pre-filled syringes with needle guard 90 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 6 pre-filled syringes with UltraSafe Passive needle guard
Maltese: 2 siringi mimlijin għal-lest b'ilqugħ għal-labra 6 siringi mimlijin għal-lest b'ilqugħ għal-labra 10 siringi mimlijin għal-lest b'ilqugħ għal-labra 20 siringi mimlijin għal-lest b'ilqugħ għal-labra 50 siringi mimlijin għal-lest b'ilqugħ għal-labra 90 siringi mimlijin għal-lest b'ilqugħ għal-labra 2 siringi mimlijin għal-lest UltraSafe Passive b'ilqugħ għal-labra 6 siringi mimlijin għal-lest UltraSafe Passive b'ilqugħ għal-labra
English: Pre-filled syringe
Maltese: Tużax Inhixa
English: 1 x 3,000 IU (30 mg) intravenous bolus plus 100 IU/kg (1 mg/kg) body weight subcutaneously and then 100 IU/kg (1 mg/kg) body weight subcutaneously every 24 hours No intravenous initial bolus, 100 IU/kg (1 mg/kg) body weight subcutaneously and then 100 IU/kg (1 mg/kg) body weight subcutaneously every 24 hours
Maltese: Doża 1 x 3,000 UI (30 mg) f'daqqa fil-vini flimkien ma' 100 UI/kg (1 mg/kg) ta' piż tal-ġisem taħt ilġilda u imbagħad 100 UI/kg (1 mg/kg) ta' piż talġisem taħt il-ġilda kull 24 siegħa