FrancophonIA/ELRC3.0 huggingface dataset:
English: Changing of anticoagulant treatment
Maltese: Bidla tat-trattament antikoagulanti
English: Operations and anaesthetics
Maltese: Operazzjonijiet u anestetiċi
English: VTE = venous thromboembolic event (DVT and/or PE) *The 95% Confidence Intervals for the treatment differences for total VTE were:
Maltese: VTE = avveniment tromboemboliku fil-vini (DVT u/jew PE) * L-intervalli ta' kunfidenza ta' 95% għad-differenzi fit-trattament għal VTE totali kienu:
English: Benzyl alcohol (150 mg in 10.0 mL)
Maltese: Alkoħol benżiliku (150 mg f'10.0 mL)
English: Inhixa is indicated in adults for:
Maltese: Inhixa huwa indikat fl-adulti għal:
English: Inhixa contains sodium
Maltese: Inhixa fih is-sodium
English: • Common: Headache*
Maltese: • Komuni: Uġigħ ta' ras*
English: Benzyl alcohol (75 mg in 5.0 mL)
Maltese: Alkoħol benżiliku (75 mg f'5.0 mL)
English: Nervous system disorders • Common: Headache*
Maltese: Disturbi fis-sistema nervuża o Komuni: Uġigħ ta' ras*
English: Immuno-allergic thrombocytopenia β: Platelet increased >400 G/L
Maltese: Tromboċitopenija immunoallerġik a β: Żieda >400 G/L fil-plejtlits
English: System Organ Class
Maltese: Klassi tassistemi u talorgani
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista taddati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: #p value versus placebo = 0.537
Maltese: 008 #valur p versus plaċebo =0.537
English: • Risk management plan (RMP)
Maltese: • Pjan tal- ġestjoni tar-riskju (RMP)
English: Benzyl alcohol (45 mg in 3.0 mL)
Maltese: Alkoħol benżiliku (45 mg fi'3.0 mL)
English: Syste m
Maltese: ANNESS I
English: 10,000 IU/mL (100 mg/mL) solution for injection
Maltese: 10,000 UI/mL (100 mg/mL) soluzzjoni għall-injezzjoni
English: • Elderly
Maltese: • Anzjani
English: Inhixa contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH).
Maltese: Inhixafih is-sustanza attiva msejħa enoxaparin sodium li hija heparin b'piż molekulari baxx (LMWH - low molecular weight heparin).
English: Pack-sizes of 1 vial containing 3 mL.
Maltese: Pakketti tad-daqsijiet ta' kunjett 1 li fihom 3 mL.
English: All Treated Medical Patients During Acute Illness Total VTE (%)
Maltese: Il-Pazjenti Kollha li Kienu Jeħtieġu Kura Medika Ttrattati Waqt Mard Akut Total ta' VTE (%)
English: Enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day SC n (%)
Maltese: Enoxaparin sodium 150 UI/kg (1.5 mg/kg) darba kuljum SC n (%)
English: • Ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory agents which are used to treat pain and swelling in arthritis and other conditions
Maltese: • Ibuprofen, diclofenac, ketorolac jew mediċini oħra magħrufa bħala sustanzi anti-infjammatorji mhux sterojdi li jintużaw biex jittrattaw uġigħ u nefħa fl-artrite u kundizzjonijiet oħra
English: Benzyl alcohol
Maltese: Alkoħol benżiliku
English: Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
Maltese: Alkoħol benżiliku ġie assoċjat mar-riskju ta' effetti sekondarji severi inkluż problemi biex tieħu nifs (imsejħa “sindrome ta' gasping”) fi tfal żgħar.
English: • you have endocarditis (an infection of the inner lining of the heart)
Maltese: • inti għadek endokartite (infezzjoni tal-inforra ta' ġewwa tal-qalb)
English: Inhixa can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI).
Maltese: Inhixa jista' jintuża għal żewġ tipi differenti ta' attakk tal-qalb imsejħa STEMI (infart mijokardijaku b'elevazzjoni fis-segment ST - ST segment elevation myocardial infarction) jew Non STEMI (NSTEMI).
English: Each mL contains 10,000 IU (100 mg) enoxaparin sodium.
Maltese: Kull mL fih 10,000 UI (100 mg) enoxaparin sodium.
English: *p value versus placebo = 0.008
Maltese: *valur p versus plaċebo =0.
English: Renal impairment (see sections 4.4 and 5.2)
Maltese: Indeboliment tal-kliewi (ara sezzjonijiet 4.4 u 5.2)
English: Organ Class
Maltese: Klassi tas
English: • Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality)
Maltese: • Komunni ħafna: Żidiet fl-enzimi tal-fwied (l-aktar it-transaminases > 3 darbiet l-ogħla limitu tan normal)
English: Benzyl alcohol may cause allergic reactions.
Maltese: Alkoħol benżiliku jista' jikkawża reazzjonijiet allerġiċi.
English: Enoxaparin sodium 2,000 IU (20 mg) once a day SC n (%)
Maltese: Enoxaparin sodium 2,000 UI (20 mg) darba kuljum SC n (%)
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: VTE = avveniment tromboemboliku fil-vini (DVT u/jew PE) * L-intervalli ta' kunfidenza ta' 95% għad-differenzi fit-trattament għal VTE totali kienu: enoxaparin sodium darba kuljum versus heparin (-3.0 sa 3.5) enoxaparin sodium kull 12-il siegħa versus heparin (-4.2 sa 1.7).
English: 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: VTE = avveniment tromboemboliku fil-vini (DVT u/jew PE) * L-intervalli ta' kunfidenza ta' 95% għad-differenzi fit-trattament għal VTE totali kienu: - enoxaparin sodium darba kuljum versus heparin (-3.0 sa 3.5) - enoxaparin sodium kull 12-il siegħa versus heparin (-4.2 sa 1.7).
English: Heparin aPTT Adjusted Intravenous Therapy n (%)
Maltese: Terapija b'Heparin fil-vini aġġustata għallaPTT n (%)
English: Enoxaparin sodium is a biological substance obtained by alkaline depolymerisation of heparin benzyl ester derived from porcine intestinal mucosa.
Maltese: Enoxaparin sodium huwa sustanza bijoloġika miksuba permezz ta' alkaline depolymerisation ta' heparin benzyl ester derivat mill-mukuża tal-musrana tal-ħnieżer.
English: You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Inhixa each day.
Maltese: Inti se tingħata 2,000 UI (20 mg) jew 4,000 UI (40 mg) ta' Inhixakuljum.
English: Immune system disorders o Common: Allergic reaction o Rare: Anaphylactic/Anaphylactoid reactions including shock*
Maltese: Disturbi fis-sistema immuni o Komuni: Reazzjoni allerġika o Rari:
English: The absolute bioavailability of enoxaparin sodium after subcutaneous 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: • Hyperkalaemia
Maltese: • Iperkalimja
English: Inhixa 30,000 IU (300 mg)/3 mL solution for injection in multidose vial Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose vial Inhixa 100,000 IU (1000 mg)/10 mL solution for injection in multidose vial enoxaparin sodium
Maltese: Informazzjoni għall-utent Inhixa 30,000 IU (300 mg)/3 mL soluzzjoni għall-injezzjoni f'kunjett b'ħafna dożi Inhixa 50,000 IU (500 mg)/5 mL soluzzjoni għall-injezzjoni f'kunjett b'ħafna dożi Inhixa 100,000
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 8 sigħat f'temperatura ta' 25 C.
English: Concomitant use not recommended:
Maltese: Tromboċitopenija Rari ħafna:
English: See section “Do not use Inhixa”.
Maltese: Ara s-sezzjoni “Tużax Inhixa”.
English: Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection Inhixa 6,000 IU (60 mg)/0.6 mL solution for injection Inhixa 8,000 IU (80 mg)/0.8 mL solution for injection Inhixa 10,000 IU (100 mg)/1 mL solution for injection enoxaparin sodium
Maltese: IU (60 mg)/0.6 mL soluzzjoni għall-injezzjoni Inhixa 8,000 IU (80 mg)/0.8 mL soluzzjoni għall-injezzjoni Inhixa 10,000
English: Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates (“Gasping Syndrome”) (see section 4.3).
Maltese: L-għoti ġol-vini tal-alkoħol benżiliku ġie assoċjat ma' avvenimenti avversi serji u mewt fi trabi tat-twelid (“Sindrome ta' Gasping”) (ara sezzjoni 4.3).
English: VTE = Venous thromboembolic events which included DVT, PE, and death considered to be thromboembolic in origin * p value versus placebo = 0.0002
Maltese: VTE = Avvenimenti tromboemboliċi fil-vini li kienu jinkludu DVT, PE, u mewt ta' oriġini tromboembolika * valur p versus plaċebo =0.
English: All Treated Extended Prophylaxis Patients Total VTE
Maltese: Il-Pazjenti Kollha Ttrattati bi Profilassi Estiża Total ta' VTE
English: Pack-sizes of 1 or 5 vials containing 10 mL.
Maltese: Pakketti tad-daqsijiet ta' 1 jew 5 kunjetti li fihom 10 mL.
English: Pack-sizes of 5 vials containing 5 mL.
Maltese: Pakketti tad-daqsijiet ta' 5 kunjetti li fihom 5 mL.
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma ddefiniti kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa <1/1,000); u rari ħafna (< 1/10,000) jew mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: One vial (3 mL) contains 30,000 IU (300 mg) enoxaparin sodium.
Maltese: Kunjett wieħed (3 mL) fih 30,000 IU (300 mg) enoxaparin sodium.
English: See “Do not use Inhixa”.
Maltese: Ara “Tużax Inhixa”.
English: Inhixa 8,000 IU (80 mg)/0.8 mL is 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: Inhixa 8,000 IU (80 mg)/0.8 mL huwa 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 aħmar.
English: Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 28 jum f'temperatura ta' 25 C.
English: Enoxaparin sodium may be safely administered with sodium chloride 9 mg/ml (0.9%) solution for infusion or 5% glucose solution for injection (see section 4.2).
Maltese: Enoxaparin sodium jista' jingħata b'mod sigur ma' sodium chloride 9 mg/ml (0.9 %) soluzzjoni għallinfużjoni jew 5 % glucose soluzzjoni għal injezzjoni (ara sezzjoni 4.2).
English: Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue - if you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin - if you have had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) - this reaction is called heparin-induced thrombocytopenia - within the last 100 days or if you have antibodies against enoxaparin in your blood - if you are bleeding heavily or have a condition with a high risk of bleeding (such as stomach ulcer, recent surgery of the brain or eyes), including recent bleeding stroke - if you are using Inhixa to treat blood clots in your body and going to receive spinal or epidural anaesthesia or lumbar puncture within 24 hours - if the patient is a premature or newborn baby up to 1 month because of the risk of severe toxicity including abnormal respiration (“gasping syndrome”).
Maltese: Sinjali ta' reazzjoni allerġika jinkludu: raxx, problemi biex tibla' jew biex tieħu nnifs, nefħa fix-xoffa, fil-wiċċ, fil-gerżuma jew fl-ilsien jekk inti allerġiku/a għall-heparin jew heparins oħra b'piż molekulari baxx bħal nadroparin, tinzaparin jew dalteparin jekk qatt kellek reazzjoni għall-heparin li kkawżat tnaqqis sever fin-numru taċ-ċelluli li jagħqqdu ddemm tiegħek (plejtlets) - din ir-reazzjoni tissejjaħ tromboċitopenija kkaġunata mill-heparinf'dawn l-aħħar 100 jum jew jekk inti għandek antikorpi kontra enoxaparin fid-demm tiegħek jekk għandek ħruġ qawwi ta' demm jew għandek kundizzjoni b'riskju kbir ta' ħruġ ta' demm (bħal ulċera fl-istonku, operazzjoni riċenti fil-moħħ jew fl-għajnejn), inkluż puplesija riċenti bi ħruġ ta' demm jekk inti qed tuża Inhixa biex titratta tagħqid tad-demm fil-ġisem tiegħek u se tirċievi anestesija fissinsla jew fl-ispazju ta' madwar id-dura jew se jkollok tneħħija ta' fluwidu mis-sit lumbar fi żmien 24 siegħa jekk il-pazjent huwa tarbija prematura jew tat-twelid sa xahar minħabba r-riskju ta' tossiċità severa inkluż respirazzjoni anormali (“sindrome ta' gasping”).
English: Common: Thrombocytosi β
Maltese: Komuni: Tromboċitożi β
English: Each mL contains 150 mg enoxaparin sodium.
Maltese: Kull mL fih 150 mg ta' enoxaparin sodium.
English: Press down on the plunger with your finger.
Maltese: Prevenzjoni ta' formazzjoni ta' trombus matul l-emodijalisi
English: One vial (3.0 mL) contains 30,000 IU (300 mg) enoxaparin sodium.
Maltese: Kunjett wieħed (3.0 mL) fih 30,000 IU (300 mg) ta' enoxaparin sodium.
English: The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: 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: Prodotti mediċinali oħra li jaffettwaw l-emostasi bħal: - Inibituri tal-aggregazzjoni tal-plejtlits inkluż acetylsalicylic acid użat bid-doża ta' antiaggregant (kardjoprotezzjoni), clopidogrel, ticlopidine, u antagonisti tal-glikoproteina IIb/IIIa indikati fis-sindrom koronarju akut minħabba r-riskju ta' fsada, - Dextran 40, - Glukokortikojdi sistemiċi.
English: The dose of protamine depends on the dose of enoxaparin sodium injected; 1 mg protamine neutralizes the anticoagulant effect of 100 IU (1 mg) of enoxaparin sodium, if enoxaparin sodium was administered in the previous 8 hours.
Maltese: Id-doża ta' protamine tiddependi fuq id-doża ta' enoxaparin sodium injettata; 1 mg protamine jinnewtralizza l-effett antikoagulanti ta' 100 UI (1 mg) ta' enoxaparin sodium, jekk enoxaparin sodium ikun ingħata fit-8 sigħat ta' qabel.
English: Intracranial haemorrhage,
Maltese: - emostasi indebolita,
English: o For patients who undergo major orthopaedic surgery an extended thromboprophylaxis up to 5 weeks is recommended.
Maltese: o Għal pazjenti li jsirulhom operazzjonijiet ortopediċi maġġuri hija rrakkomandata tromboprofilassi estiża sa 5 ġimgħat.
English: CARTON OF (Packs of 2, 6, 10, 12, 24, 30, 50 or 90)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ L-IMBALLAĠĠ ESTERN KARTUNA TA' (Pakketti ta' 2, 6, 10, 12, 24, 30, 50 jew 90)
English: The mean maximum anti-IIa activity level is observed approximately 3 to 4 hours following subcutaneous 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: Il-medja tal-livell tal-attività massima anti-IIa jiġi osservat madwar 3 sa 4 sigħt wara injezzjoni taħt ilġilda u jilħaq 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: Changing from treatment with direct oral anticoagulant to Inhixa Stop taking direct oral anticoagulant.
Maltese: Bidla minn trattament b'antikoagulant orali dirett għal Inhixa Ieqaf ħu l-antikoagulant orali dirett.
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: Skin and subcutaneous tissue disorders o Common: Urticaria, pruritus, erythema o Uncommon: Bullous dermatitis o Rare: Alopecia* o Rare: Cutaneous vasculitis*, skin necrosis* usually occurring at the injection site (these phenomena have been usually preceded by purpura or erythematous plaques, infiltrated and painful).
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda o Komuni: Urtikarja, ħakk, eritema o Mhux komuni: Dermatite bulluża o Rari: Alopeċja* o Rari:
English: - Changing from treatment with direct oral anticoagulant to Inhixa Stop taking direct oral anticoagulant.
Maltese: - Bidla minn trattament b'antikoagulant orali dirett għal Inhixa Ieqaf ħu l-antikoagulant orali dirett.
English: Inhixa 6,000 IU (60 mg)/0.6 mL injection enoxaparin sodium
Maltese: Inhixa 6,000 IU (60 mg)/0.6 mL soluzzjoni għall-injezzjoni enoxaparin
English: The rates of venous thromboembolism at the end of the double-blind phase were 12.0 % (n=20) in the placebo group and 4.8% (n=8) in the enoxaparin sodium group; p=0.02.
Maltese: Ir-rati ta' tromboemboliżmu fil-vini fl-aħħar tal-fażi fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża kienu 12.0 % (n = 20) fil-grupp tal-plaċebo u 4.8% (n = 8) fil-grupp ta' enoxaparin sodium; p = 0.02.
English: Inhixa 15,000 IU (150 mg)/1 mL is 1 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a dark blue polypropylene plunger rod.
Maltese: IU (150 mg)/1 mL huwa 1 mL ta' soluzzjoni fi: - 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 blu skur.
English: Each pre-filled 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: 10) Drop the used syringe the sharps container.
Maltese: 10) Armi s-siringa użata fil-kontenitur tal-oġġetti jaqtgħu.
English: Inhixa is a biosimilar medicinal product.
Maltese: Inhixa huwa prodott mediċinali bijoloġiku simili.
English: Overall list of possible side effects Very common ( may affect more than 1 in 10 people)
Maltese: Lista totali ta' effetti sekondarji possibbli Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10)
English: Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection
Maltese: Inhixa 2,000 IU (20 mg)/0.2 mL soluzzjoni għall-injezzjoni
English: One vial contains enoxaparin sodium 30,000 IU anti-Xa activity (equivalent to 300 mg) in 3.0 mL water for injections.
Maltese: U KWANTITATTIVA Kunjett wieħed fih enoxaparin sodium 30,000 UI ta' attività anti-Xa (ekwivalenti għal 300 mg) f'3 mL ilma għall-injezzjonijiet.
English: Inhixa 6,000 IU (60 mg)/0.6 mL is 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: Inhixa 6,000 IU (60 mg)/0.6 mL huwa 0.6 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 oranġjo.
English: • Haemorrhage
Maltese: • Emorraġija
English: Inhixa 15,000 IU (150 mg)/1 mL injection enoxaparin sodium
Maltese: IU (150 mg)/1 mL soluzzjoni għall-injezzjoni enoxaparin sodium
English: Treatment of deep vein thrombosis with or without pulmonary embolism In a multicentre, parallel group study, 900 patients with acute lower extremity DVT with or without PE were randomized to an inpatient (hospital) treatment of either (i) enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day subcutaneously, (ii) enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours subcutaneously, or (iii) heparin intravenous bolus (5,000 IU) followed by a continuous infusion (administered to achieve an aPTT of 55 to 85 seconds).
Maltese: Fi studju b'ħafna ċentri, bi grupp parallell, 900 pazjent b'DVT akuta f'riġel b'PE jew mingħajru ntagħżlu b'mod arbitrarju għal trattament bħala pazjenti rikoverati fi sptar jew ta' (i) enoxaparin sodium 150 UI/kg (1.5 mg/kg) darba kuljum taħt il-ġilda, (ii) enoxaparin sodium 100 UI/kg (1 mg/kg) kull 12-il siegħa taħt il-ġilda, jew (iii) heparin (5,000 UI) f'daqqa fil-vini segwit minn infużjoni kontinwa (mogħtija biex tikseb aPTT ta' 55 sa 85 sekonda).
English: Thrombocytop enia
Maltese: Tromboċitope nija
English: • The maximum amount of Inhixa given for the first two injections is 7,500 IU (75 mg).
Maltese: • L-ammont massimu ta' Inhixa mogħti għall-ewwel żewġ injezzjonijiet jkun 7,500 UI (75 mg).
English: • Severe renal impairment
Maltese: • Indeboliment sever tal-kliewi
English: Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to Inhixa Stop taking the vitamin-K antagonist.
Maltese: Bidla minn Inhixa - għal mediċini li jraqqu d-demm imsejħa antagonisti tal-vitamina K (eż. warfarin)
English: Inhixa 8,000 IU (80 mg)/0.8 mL injection enoxaparin sodium
Maltese: Inhixa 8,000 IU (80 mg)/0.8 mL soluzzjoni għall-injezzjoni Enoxaparin
English: The anticoagulant effects can be largely neutralized by the slow intravenous injection of protamine.
Maltese: L-effetti antikoagulanti jistgħu jiġu nnewtralizzati permezz ta' injezzjoni bil-mod ta' protamine fil-vini.
English: Inhixa 4,000 IU (40 mg)/0.4 mL
Maltese: IU (40 mg)/0.4 mL
English: : such as haematoma, ecchymosis other than at injection site, wound haematoma, haematuria, epistaxis and gastro-intestinal haemorrhage.
Maltese: : bħal ematoma, ekkimożi f'postijiet oħra li mhumiex il-post tal-injezzjoni, ematoma fil-ferita, ematurja, epistassi, u emorraġija gastrointestinali.
English: Inhixa 15,000 IU (150 mg)/ mL
Maltese: IU (150 mg)/ mL
English: The incidence of major bleeding at 30 days was significantly higher (p < 0.0001) in the enoxaparin sodium group (2.1%) versus the heparin group (1.4%).
Maltese: L-inċidenza ta' ħruġ ta' demm maġġuri mat-30 jum kienet ogħla b'mod sinigfikanti (p < 0.0001) fil-grupp ta' enoxaparin sodium (2.1%) versus il-grupp ta' heparin (1.4%).
English: Common: Thrombocytopenia
Maltese: Komuni: Tromboċitopenija
English: Inhixa 12,000 IU (120 mg)/0.8 mL
Maltese: IU (120 mg)/0.8 mL
English: EU/1/16/1132/074 EU/1/16/1132/078 EU/1/16/1132/080 EU/1/16/1132/079 EU/1/16/1132/070
Maltese: EU/1/16/1132/078 EU/1/16/1132/080 EU/1/16/1132/079 EU/1/16/1132/070
English: Prophylaxis in medical patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: Inhixa 100,000 IU (1000 mg)/10 mL
Maltese: IU (1000 mg)/10 mL
English: CARTON OF (Packs of 2, 5, 6, 10, 20, 30, 50 or 90)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ L-IMBALLAĠĠ ESTERN KARTUNA TA' (Pakketti ta' 2, 5, 6, 10, 20, 30, 50 jew 90)
English: • Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism (VTE).
Maltese: • Profilassi ta' mard tromboemboliku fil-vini f'pazjenti li jeħtieġu kura medika li għandhom mard akut (bħal insuffiċjenza akuta tal-qalb, insuffiċjenza respiratorja, infezzjonijiet severi jew mard rewmatiku) u mobilita` mnaqqsa li qegħdin f'riskju akbar ta' tromboemboliżmu fil-vini (VTE).
English: Overall list of possible side effects: Very common ( may affect more than 1 in 10 people)
Maltese: Lista totali ta' effetti sekondarji possibbli: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10)
English: Thrombocytopenia Very rare:
Maltese: Eosinofilja* o Rari: