FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of unstable angina and non ST elevation myocardial infarction In a large multicentre study, 3,171 patients enrolled at the acute phase of unstable angina or non-Q-wave myocardial infarction were randomized to receive in association with acetylsalicylic acid (100 to 325 mg once daily), either subcutaneous enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours or intravenous 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 taħt il-ġilda enoxaparin sodium 100 UI/kg (1 mg/kg) kull 12-il siegħa jew inkella heparin fil-vini mhux frazzjonat aġġustat abbażi tal-aPTT.
English: - At doses used for prophylaxis
Maltese: - Bid-dożi użati għall-profilassi
English: 2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 12 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 24 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 10 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 12 siringi mimlijin għal-lest b'ilqugħ għal-labra 20 siringi mimlijin għal-lest b'ilqugħ għal-labra 24 siringi mimlijin għal-lest b'ilqugħ għal-labra 30 siringi mimlijin għal-lest b'ilqugħ għal-labra 2 siringi mimlijin għal-lest UltraSafe Passive b'ilqugħ għal-labra 10 siringi mimlijin għal-lest UltraSafe Passive b'ilqugħ għal-labra
English: EU/1/16/1132/007 EU/1/16/1132/008 EU/1/16/1132/017 EU/1/16/1132/018 EU/1/16/1132/029 EU/1/16/1132/030 EU/1/16/1132/039 EU/1/16/1132/040 EU/1/16/1132/047 EU/1/16/1132/048 EU/1/16/1132/059 EU/1/16/1132/060 EU/1/16/1132/084
Maltese: EU/1/16/1132/007 EU/1/16/1132/008 EU/1/16/1132/017 EU/1/16/1132/018 EU/1/16/1132/029 EU/1/16/1132/030 EU/1/16/1132/039 EU/1/16/1132/040
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Maltese: F'pazjenti li għamlu operazzjoni, kumplikazzjonijiet ta' emorraġijia kienu meqjusa bħala maġġuri:
English: In patients with severe renal impairment (creatinine clearance 15-30 mL/min), since exposure of enoxaparin sodium is significantly increased, a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges (see section 4.2).
Maltese: Għall-pazjenti bi tneħħija talkreatinina [15-30 mL/minuta], huma meħtieġa kunsiderazzjonijiet addizzjonali minħabba li leliminazzjoni ta' enoxaparin sodium tkun imdewma aktar (ara sezzjoni 4.2).
English: • For treatment of acute STEMI, the recommended dose of enoxaparin sodium is a single intravenous (IV) bolus of 3,000 IU (30 mg) plus a 100 IU/kg (1 mg/kg) SC dose followed by 100 IU/kg (1 mg/kg) administered SC every 12 hours (maximum 10,000 IU (100 mg) for each of the first two SC doses).
Maltese: • Għat-trattament ta' STEMI akut, id-doża rrakkomandata ta' enoxaparin sodium hija doża waħda f'daqqa fil-vini ta' 3,000 UI (30 mg) flimkien ma' doża ta' 100 UI/kg (1 mg/kg) taħt il-ġilda segwita minn 100 UI/kg (1 mg/kg) mogħtija taħt il-ġilda kull 12-il siegħa (massimu ta' 10,000 UI (100 mg) għal kull waħda mill-ewwel żewġ dożi taħt il-ġilda).
English: Chełmska 30/34
Maltese: 30 siringi mimlijin għal-lest
English: In clinical studies, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see sections 4.4 and “Description of selected adverse reactions” below).
Maltese: Fi studji kliniċi, emorraġiji, tromboċitopenija u tromboċitożi kienu l-aktar reazzjonijiet irrappurtati b'mod komuni (ara sezzjoni 4.4 u d-'Deskrizzjoni ta' reazzjonijiet avversi magħżula' taħt).
English: Spinal/Epidural anaesthesia or lumbar puncture
Maltese: Nekrożi fil-ġilda/vaskulite kutanja
English: Medicinal products increasing potassium levels
Maltese: Prodotti mediċinali li jżidu l-livelli tal-potassium
English: 10 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: 10 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: Packs of: - 2, 6, 10, 30, 50 and 90 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Maltese: Fornuti f'pakketti ta': - 2, 6, 10, 30, 50 u 90 siringi mimlija għal- lest - 2, 6, 10, 12, 24 u 30 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra - 2 u 10 siringi mimlija minn UltraSafe Passive qabel b'tagħmir ta' tarka għal-labra
English: Diluted medicinal product with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose
Maltese: Wara dilwizzjoni b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-infużjoni jew 5% glucose soluzzjoni għall-injezzjoni
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 < 0.001).
English: Pregnancy
Maltese: Emorraġiji
English: B. PACKAGE LEAFLET
Maltese: • Pazjenti b'ħafna Piż Żejjed
English: Inhixa 12,000 IU (120 mg)/0.8 mL injection enoxaparin sodium
Maltese: IU (120 mg)/0.8 mL soluzzjoni għall-injezzjoni enoxaparin sodium
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: Fit-tieni studju fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, 262 pazjent mingħajr mard ta' VTE u li jkunu qed jagħmlu operazzjoni għall-bdil tal-għadma tal-ġenbejn, 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: Inhixa 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: 2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 12 pre-filled syringes with needle guard 24 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 10 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 12 siringi mimlijin għal-lest b'ilqugħ għal-labra 24 siringi mimlijin għal-lest b'ilqugħ għal-labra 30 siringi mimlijin għal-lest b'ilqugħ għal-labra 2 siringi mimlijin għal-lest UltraSafe Passive b'ilqugħ għal-labra 10 siringi mimlijin għal-lest UltraSafe Passive b'ilqugħ għal-labra
English: EU/1/16/1132/001 EU/1/16/1132/002 EU/1/16/1132/011 EU/1/16/1132/012 EU/1/16/1132/021 EU/1/16/1132/023 EU/1/16/1132/033 EU/1/16/1132/034 EU/1/16/1132/051 EU/1/16/1132/053 EU/1/16/1132/054 EU/1/16/1132/064 EU/1/16/1132/065
Maltese: EU/1/16/1132/001 EU/1/16/1132/002 EU/1/16/1132/011 EU/1/16/1132/012 EU/1/16/1132/021 EU/1/16/1132/023 EU/1/16/1132/033 EU/1/16/1132/034
English: Inhixa 30,000 IU (300 mg)/3 mL solution for injection in multidose vial enoxaparin sodium
Maltese: Inhixa 30,000 IU (300 mg)/3 mL soluzzjoni għall-injezzjoni f'kunjett b'ħafna dożi enoxaparin
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) taħt il-ġilda kull 12-il siegħa (massimu ta' 75 00 UI (75 mg) għal kull waħda mill-ewwel żewġ dożi taħt il-ġilda biss, segwita minn għoti ta' doża ta' 75 UI/kg (0.75 mg/kg) taħt il-ġilda għall-kumplament tad-dożi).
English: The contents of the bag should be gently mixed.
Maltese: Fornuti f'pakketti ta' kunjett wieħed.
English: Enoxaparin sodium 4,000 IU (40 mg) once a day subcutaneously n (%)
Maltese: Enoxaparin sodium 4,000 UI (40 mg) darba kuljum taħt il-ġilda n (%)
English: Do not use Inhixa
Maltese: Ilma għall-injezzjonijiet
English: Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Maltese: Fornuti f'pakketti ta': - 2, 6, 10, 30 u 50 siringi mimlija għal- lest - 2, 6, 10, 12, 20, 24 u 30 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra - 2 u 10 siringi mimlija minn UltraSafe Passive qabel b'tagħmir ta' tarka għal-labra
English: Packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Maltese: Pakketti ta': - 1, 2, 6, 10 jew 50 siringa(i) mimlija għal- lest - 2, 6, 10, 20, 50 jew 90 siringi mimlija minn qabel b'tagħmir tagħmir ta' tarka għal-labra - 2 jew 6 siringi mimlija minn UltraSafe Passive qabel b'tagħmir ta' tarka għal-labra
English: To avoid the possible mixture of enoxaparin sodium with other drugs, the intravenous access chosen should be flushed with a sufficient amount of sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose solution prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug.
Maltese: Biex tiġi evitata l-possibbiltà ta' taħlit ta' enoxaparin sodium ma' mediċini oħra, l-aċċess fil-vini magħżul għandu jitlaħlaħ b'ammont suffiċjenti ta' soluzzjoni ta' sodium chloride 9 mg/mL (0.9 %) soluzzjoni għall-infużjoni jew glucose qabel u wara l-għoti f'daqqa ta' enoxaparin sodium fil-vini biex jitnaddaf il-post minn fejn tkun ġiet introdotta l-mediċina.
English: Enoxaparin sodium may be safely administered with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose in water.
Maltese: Enoxaparin sodium jista' jingħata mingħajr periklu flimkien ma' sodium chloride 9 mg/ml (0.9%) soluzzjoni għal injezzjoni jew 5% dextrose fl-ilma.
English: What Inhixa looks like and contents of the pack Inhixa 12,000 IU (120 mg)/0.8 mL is 0.8 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 purple polypropylene plunger rod.
Maltese: IU (120 mg)/0.8 mL huwa 0.8 mL ta' soluzzjoni fi: - f'bettija tas-siringa ta' ħġieġ newtrali ċar, mingħajr kulur tat-tip I b'labra mwaħħla u għatu tallabra magħluq b'tapp tal-gomma tal-chlorobutyl u virga tal-planġer ta' polypropylene vjola.
English: The rate of the 30 day composite endpoint of death, myocardial re-infarction or intracranial haemorrhage (a measure of net clinical benefit) was significantly lower (p<0.0001) in the enoxaparin sodium group (10.1%)
Maltese: Ir-rata fit-30 jum tal-iskop finali kompost ta' mewt, infart mijokardijaku mill-ġdid jew emorraġija ġolkranju (kejl tal-benefiċċju nett klinku) kienet b'mod sinifikanti aktar baxxa (p < 0.0001) fil-grupp ta' enoxaparin sodium (10.
English: Enoxaparin sodium may be safely administered with sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose in water for injections.
Maltese: Enoxaparin sodium jista' jingħata mingħajr periklu flimkien ma' soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-infużjoni (0.9%) jew 5% glucose fl-ilma għall-injezzjonijiet.
English: Intracranial haemorrhage, Retroperitoneal haemorrhage
Maltese: • inti għandek pressjoni għolja
English: Each pre-filled 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: Treatment of acute ST-segment elevation myocardial infarction In a large multicentre study, 20,479 patients with STEMI eligible to receive fibrinolytic therapy were randomized to receive either enoxaparin sodium in a single 3,000 IU (30 mg) intravenous bolus plus a 100 IU/kg (1 mg/kg) subcutaneous dose followed by an subcutaneous injection of 100 IU/kg (1 mg/kg) every 12 hours or intravenous unfractionated heparin adjusted based on aPTT for 48 hours.
Maltese: Trattament ta' infart mijokardijaku akut b'elevazzjoni fis-segment ST Fi studju kbir b'ħafna ċentri, 20,479 pazjent bi STEMI eliġibbli biex jirċievu terapija fibrinolitika ntagħżlu b'mod arbitrarju biex jew jirċievu enoxaparin sodium b'doża f'daqqa ta' 3,000 UI (30 mg) fil-vini flimkien ma' doża ta' 100 UI/kg (1 mg/kg) taħt il-ġilda segwita minn injezzjoni taħt il-ġilda ta' 100 UI/kg (1 mg/kg) kull 12-il siegħa jew heparin fil-vini mhux frazzjonat aġġustat abbażi tal-aPTT għal 48 siegħa.
English: Other medicines and Inhixa
Maltese: Mediċini oħra u Inhixa
English: 5 pre-filled syringes6 pre-filled syringes 10 pre-filled syringes
Maltese: Jekk isseħħ tromboċitopenija, din issoltu tidher bejn il-5
English: Each pre-filled 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: Enoxaparin sodium pharmacokinetics appeared similar than control population, after a single 25 IU, 50 IU or 100 IU/kg (0.25, 0.50 or 1.0 mg/kg) intravenous dose however, AUC was two-fold higher than control.
Maltese: UI jew 100 UI/kg (0.25, 0.50 jew 1.0 mg/kg) fil-vini madankollu, l-AUC kienet darbtejn aktar mill-kontroll.
English: 4) Carefully pull off the needle cap from the syringe.
Maltese: Jekk le, uża siringa oħra.
English: One vial (5.0 mL) contains 50,000 IU (500 mg) enoxaparin sodium.
Maltese: Kull mL fih 10,000 UI (100 mg) enoxaparin sodium Kunjett wieħed (5 mL) fih 50,000 IU (500 mg) enoxaparin sodium.
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: Enoxaparin sodium 2,000 IU (20 mg) once a day subcutaneously n (%)
Maltese: Enoxaparin sodium 2,000 UI (20 mg) darba kuljum taħt il-ġilda n (%)
English: There were no significant differences in major haemorrhages, although a haemorrhage at the site of the SC injection was more frequent.
Maltese: Huwa importanti għalik li inti tkompli tieħu injezzjonijiet Inhixa sakemm it-tabib tiegħek jiddeċiedi li jwaqqafhom.
English: These factors are known to contribute to the overall antithrombotic effect of enoxaparin sodium.
Maltese: Dawn il-fatturi huma magħrufa li jikkontribwixxu għall-effett antitrombotiku globali ta' enoxaparin sodium.
English: 0.2 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 blue polypropylene plunger rod.
Maltese: 0.2 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 blu.
English: After dilution with sodium chloride 9 mg/ml (0.9%) solution for infusion or 5% glucose solution for injection.
Maltese: Wara dilwizzjoni b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-infużjoni jew 5% glucose soluzzjoni għall-injezzjoni.
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: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi attiva/i
English: OUTER BOX MULTIDOSE VIAL
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: 90 pre-filled syringes
Maltese: 90 siringi mimlijin għal-lest
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: Inhixa 2,000 IU (20 mg)/0.2 mL injection enoxaparin sodium
Maltese: IU (20 mg)/0.2 mL soluzzjoni għall-injezzjoni enoxaparin
English: Each pre-filled syringe contains enoxaparin sodium 15,000 IU anti-Xa activity (equivalent to 150 mg) in 1 mL water for injections.
Maltese: UI ta' attività anti-Xa (ekwivalenti għal 150 mg) f'1 mL ilma għall-injezzjonijiet.
English: Patients receiving the twice daily doses (i.e. 75 IU/kg (0.75 mg/kg) twice daily or 100 IU/kg (1 mg/kg) twice-daily) should omit the second enoxaparin sodium dose to allow a sufficient delay before catheter placement or removal.
Maltese: UI/kg (0.75 mg/kg) darbtejn kuljum jew 100 UI/kg (1 mg/kg) darbtejn kuljum) għandhom jaqbżu doża ta' enoxaparin sodium biex jitħalla dewmien biżżejjed għat-tqegħid jew it-tneħħija tal-kateter.
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 tallabra magħluq b'tapp tal-gomma tal-chlorobutyl u virga tal-planġer ta' polypropylene oranġjo.
English: Each pre-filled 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: - The other ingredients are benzyl alcohol (see section 2) and water for injections.
Maltese: - L-ingredjenti l-oħra huma alkoħol benżiliku (ara sezzjoni 2) u 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 ggradata ta' ħġieġ newtrali ċar, mingħajr kulur tat-tip I b'labra mwaħħla u għatu tallabra magħluq b'tapp tal-gomma tal-chlorobutyl u virga tal-planġer ta' polypropylene aħmar.
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 medicinal products 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' prodotti mediċinali li jaffettwaw l-emostasi (ara sezzjonijiet 4.4 u 4.5).
English: Packs of: - 2, 10 and 30 pre-filled syringes, - 10 and 30 pre-filled syringes with needle guard.
Maltese: Pakketti ta': - 2, 10 jew 30 siringi mimlija għal-lest - 10 jew 30 siringi mimlija għal-lest b'apparat tas-sikurezza tal-labar
English: Volume to inject when diluted to a final concentration of 300 IU (3 mg)/mL
Maltese: Volum li għandu jiġi injettat meta jkun iddilwit għal konċentrazzjoni finali ta' 300 IU (3 mg)/mL
English: • If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of Inhixa each day.
Maltese: • Jekk inti għandek mobilità ristretta minħabba mard, is-soltu tingħata 4,000 UI (40 mg) ta' Inhixakuljum.
English: Supplied in packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 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': - 1, 2, 6, 10 jew 50 siringa(i) mimlija għal- lest - 2, 6, 10, 20, 50 jew 90 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra - 2 jew 6 siringi mimlija minn UltraSafe Passive qabel b'tagħmir ta' tarka għal-labra
English: Prophylaxis of venous thromboembolism in medical patients The recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily by subcutaneous injection.
Maltese: Id-doża rrakkomandata ta' enoxaparin sodium hija 4,000 UI (40 mg) darba kuljum permezz ta' injezzjoni taħt il-ġilda.
English: All patients also received warfarin sodium (dose adjusted according to prothrombin time to achieve an INR of 2.0 to 3.0), commencing within 72 hours of initiation of enoxaparin sodium or standard heparin therapy, and continuing for 90 days.
Maltese: Il pazjenti kollha rċivew ukoll warfarin sodium (doża aġġustata skont il-ħin tal-protrombin biex jinkisebINR ta' 2.0 sa 3.0), li nbeda fi żmien 72 siegħa minn meta nbdew enoxaparin sodium jew terapija standard bil-heparin, u tkompla għal 90 jum.
English: Inhixa works in two ways.
Maltese: Inhixa jaħdem b'żewġ modi.
English: Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as: - impaired haemostasis, - history of peptic ulcer, - recent ischemic stroke, - severe arterial hypertension, - recent diabetic retinopathy, - neuro- or ophthalmologic surgery, - concomitant use of medications affecting haemostasis (see section 4.5).
Maltese: - storja ta' ulċera fl-istonku, - puplesija iskemika riċenti, - pressjoni għolja severa fl-arterji, - retinopatija tad-dijabete riċenti, - operazzjoni newroloġika jew oftalmoloġika, - l-użu flimkien ta' mediċini li jaffettwaw l-emostasi (ara sezzjoni 4.5).