FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Brimica Genuair's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Brimica Genuair huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Brimica Genuair than with formoterol alone.
Maltese: FEV1 imkejjel filgħodu qabel it-teħid man-nifs kien 68 ml aktar bi Brimica Genuair milli b'formoterol waħdu.
English: For the full list of all side effects and restrictions with Brimica Genuair, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Brimica Genuair, ara l-fuljett ta' tagħrif.
English: The two active substances in Brimica Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.
Maltese: Iż-żewġ sustanzi attivi fi Brimica Genuair, bromur tal-aklidinju u diidrat tal-fumarat tal-formoterol, jaħdmu billi jżommu l-passaġġi tal-arja miftuħin u l-pazjent ikun jista' jieħu n-nifs aktar faċli.
English: Athens, Attiki 15771
Maltese: Ateni, Attiki 15771
English: • Laboratory tests
Maltese: • Testijiet tal-laboratorju
English: Overall list of possible side effects:
Maltese: Lista totali ta' effetti sekondarji possibbli:
English: • Skin irritation (local irritation).
Maltese: • Irritazzjoni fil-ġilda (irritazzjoni lokali).
English: • Acute infective endocarditis
Maltese: • Endokardite infettiva akuta
English: Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11 1077XX Amsterdam Netherlands
Maltese: Strawinskylaan 1143, Toren C-11 1077XX Amsterdam Olanda
English: Operations and anesthetics
Maltese: Operazzjonijiet u Anestetiċi
English: LMWHs are biological medicinal products.
Maltese: LMWHs huma prodotti mediċinali bijoloġiċi.
English: • SC injection technique:
Maltese: • Teknika tal-injezzjoni SC:
English: Shenzhen Techdow Pharmaceutical Co., Ltd No.19, Gaoxinzhongyi Road, Hi-tech Industrial Park Nanshan District
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi attiva/i Shenzhen Techdow Pharmaceutical Co., Ltd No.19, Gaoxinzhongyi Road, Hi-tech Industrial Park Nanshan District
English: Common: Haemorrhage α
Maltese: Komuni: Emorraġija α
English: • Total DVT (%)
Maltese: • Total ta' DVT (%)
English: • Uncommon: Bullous dermatitis
Maltese: • Mhux komuni: Dermatite bulluża
English: This reduction in the combined incidence was maintained after 30 days (from 23.3 to 19.8%; relative risk reduction of 15%).
Maltese: Dan it-tnaqqis fl-inċidenza kkombinata inżamm wara 30 jum (minn 23.3 għal 19.8%; tnaqqis relattiv fir-riskju ta' 15%).
English: Heparin aPTT Adjusted IV Therapy n (%)
Maltese: Terapija b'Heparin IV aġġustata għallaPTT n (%)
English: A total of 1,102 patients were enrolled in the study, and 1,073 patients were treated.
Maltese: Total ta' 1,102 pazjenti ġew irreġistrati fl-istudju, u ġew ittrattati 1,073 pazjent.
English: • Rare: Eosinophilia*
Maltese: Eosinofilja*
English: • Skin rash (hives, urticaria).
Maltese: • Raxx fil-ġilda (ħorriqija, uritkarja).
English: Diluted medicinal product with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose 8 hours
Maltese: Prodott mediċinali dilwit b' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew 5% glucose 8 sigħat
English: Date of first authorisation: 15/09/2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15/09/2016
English: See “Do not use Thorinane”.
Maltese: Ara “Tużax Thorinane”.
English: Required dose 30 IU/kg (0.3 mg/kg)
Maltese: Doża meħtieġa 30 UI/kg (0.3 mg/kg)
English: There are no clinical data for enoxaparin sodium in fertility.
Maltese: Ma hemm l-ebda dejta klinika għal enoxaparin sodium fil-fertilità.
English: • Common: Allergic reaction
Maltese: • Komuni: Reazzjoni allerġika
English: Acute coronary syndrome: treatment of unstable angina and NSTEMI and treatment of acute STEMI
Maltese: Sindrom koronarju akut: trattament ta' anġina mhux stabbli u NSTEMI u trattament ta' STEMI akut
English: In the in vitro purified system, enoxaparin sodium has a high anti-Xa activity (approximately 100 IU/mg) and low anti-IIa or anti thrombin activity (approximately 28 IU/mg), with a ratio of 3.6.
Maltese: Fis-sistema purifikata in vitro, enoxaparin sodium għandu attività anti-Xa għolja (madwar 100 UI/mg) u attività anti-IIa jew attività kontra t-trombin baxxa (madwar 28 UI/mg), bi proporzjon ta' 3.6.
English: Investigations • Rare: Hyperkalaemia* (see sections 4.4 and 4.5).
Maltese: Iperkalimja*(ara sezzjonijiet 4.4 u 4.5)
English: What Thorinane contains - The active substance is enoxaparin sodium.
Maltese: X'fih Thorinane - Is-sustanza attiva hija enoxaparin sodium.
English: Thorinane is indicated in adults for:
Maltese: Thorinanehuwa indikat fl-adulti għal:
English: Treatment of acute STEMI (patients over 75)
Maltese: Trattament ta' STEMI akut (pazjenti li għandhom aktar minn 75 sena)
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 linċidenza 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: Treatment of acute STEMI (patients under 75)
Maltese: Trattament ta' STEMI akut (pazjenti taħt il75 sena)
English: Common: Thrombocytosis β
Maltese: Komuni: Tromboċitożi β
English: Pharmacotherapeutic group: Antithrombotic agents, heparin group.
Maltese: Sustanzi antitrombotiċi, grupp ta' eparina.
English: • Common: Haemorrhage, haemorrhagic anaemia*, thrombocytopenia, thrombocytosis
Maltese: • Komuni: Emorraġija, anemija minn emorraġija*, tromboċitopenija, tromboċitożi
English: For patients have an operation called percutaneous coronary intervention (PCI):
Maltese: Għall-pazjenti li jkollhom operazzjoni msejħa intervent koronarju perkutanju (PCI - percutaneous coronary intervention):
English: Enoxaparin sodium 4,000 IU (40 mg) once a day SC n (%)
Maltese: Enoxaparin sodium 4,000 UI (40 mg) darba kuljum SC n (%)
English: Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred.
Maltese: Saret venografija bilaterali bejn il-jiem 25 u 31, jew qabel jekk seħħew sintomi ta' tromboemboliżmu fil-vini.
English: • Proximal DVT (%)
Maltese: • DVT Prossimali (%)
English: • IV (bolus) injection (for acute STEMI indication only):
Maltese: • Injezzjoni IV (f'daqqa) (għall-indikazzjoni ta' STEMI akut biss):
English: A 3,000 IU (30 mg) IV bolus immediately followed by a 100 IU/kg (1 mg/kg) SC 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 IV segwita immedjatament minn 100 UI/kg (1 mg/kg) SC 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: - Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).
Maltese: - Trattament ta' infart mijokardijaku akut b'elevazzjoni tas-segment ST (STEMI - acute STsegment elevation myocardial infarction) inkluż pazjenti li se jiġu mmaniġġjati b'mod mediku jew b'intervent koronarju perkutanju sussegwenti (PCI - percutaneous coronary intervention).
English: Dosage table for patients with severe renal impairment (creatinine clearance [15-30] mL/min):
Maltese: Tabella tad-dożi u l-għoti għal pazjenti b'indeboliment sever tal-kliewi (teħħija tal-kreatinina [15-30] mL/min):
English: • 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: Enoxaparin is a LMWH with a mean molecular weight of approximately 4,500 daltons, in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated.
Maltese: Enoxaparin huwa LMWH b'medja tal-piż molekulari ta' madwar 4,500 daltons, li fih l-attivitajiet antitrombotiċi u antikoagulanti tal-heparin standard ġew isseparati.
English: • Medicinal products increasing potassium levels:
Maltese: • Prodotti mediċinali li jżidu l-livelli tal-potassium:
English: The anticoagulant effects can be largely neutralized by the slow IV injection of protamine.
Maltese: L-effetti antikoagulanti jistgħu jiġu nnewtralizzati permezz ta' injezzjoni bil-mod ta' protamine IV.
English: IU
Maltese: JIS
English: In comparison with heparin, enoxaparin sodium significantly reduced the combined incidence of angina pectoris, myocardial infarction and death, with a decrease of 19.8 to 16.6% (relative risk reduction of 16.2%) on day 14.
Maltese: Meta mqabbel mal-heparin, enoxaparin sodium naqqas b'mod sinifikanti l-inċidenza kkombinata ta' angina pectoris, infart mijokardijaku u mewt, bi tnaqqis ta' 19.8 għal 16.6% (tnaqqis relattiv fir-riskju ta' 16.2%) fil-jum 14.
English: Placebo once a day SC n (%)
Maltese: Plaċebo darba kuljum SC n (%)
English: • Common: Urticaria, pruritus, erythema
Maltese: • Komuni: Urtikarja, ħakk, eritema
English: For continuous techniques, a similar delay of 24 hours should be observed before removing the
Maltese: Għal tekniki kontinwi, dewmien simili ta' mill-anqas 24 siegħa għandu jiġi osservat qabel ma
English: Enoxaparin sodium 100 IU/kg (1 mg/kg) twice a day SC n (%)
Maltese: Enoxaparin sodium 100 UI/kg (1 mg/kg) darbtejn kuljum SC n (%)
English: Enoxaparin sodium or standard heparin therapy was administered for a minimum of 5 days and until the targeted warfarin sodium INR was achieved.
Maltese: Enoxaparin sodium jew terapija standard bil-heparin ingħataw għal minimu ta' 5 ijiem u sakemm inkiseb l-INR ta' warfarin sodium fil-mira.
English: You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Thorinane each day.
Maltese: Inti se tingħata 2,000 UI (20 mg) jew 4,000 UI (40 mg) ta' Thorinanekuljum.
English: Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials.
Maltese: Enoxaparin sodium ġie evalwat f'aktar minn 15,000 pazjent li rċivew enoxaparin sodium fi provi kliniċi.
English: Enoxaparin sodium is a biological substance obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa.
Maltese: Enoxaparin sodium huwa sustanza bijoloġika miksuba permezz ta' alkaline depolymerization ta' heparin benzyl ester derivat mill-mukuża tal-musrana tal-ħnieżer.
English: GREECE
Maltese: Olanda
English: Thorinane contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH).
Maltese: Thorinanefih is-sustanza attiva msejħa enoxaparin sodium li hija heparin b'piż molekulari baxx (LMWHlow molecular weight heparin).
English: The volume of distribution of enoxaparin sodium anti-Xa activity is about 4.3 litres and is close to the blood volume.
Maltese: Il-volum ta' distribuzzjoni tal-attività anti-Xa ta' enoxaparin sodium hija madwar 4.3 litri u hija qrib ilvolum tad-demm.
English: The occurrence of total and major bleeding were respectively 8.6% and 1.1% in the placebo group, 11.7% and 0.3% in the enoxaparin sodium 2,000 IU (20 mg) group and 12.6% and 1.7% in the enoxaparin sodium 4,000 IU (40 mg) group.
Maltese: L-okkorrenza ta' fsada totali u maġġuri kienu rispettivament 8.6% u 1.1% fil-grupp tal-plaċebo, 11.7% u 0.3% fil-grupp ta' enoxaparin sodium 2,000 UI (20 mg) u 12.6% u 1.7% fil-grupp ta' enoxaparin sodium 4,000 UI (40 mg).
English: Prevention of thrombus formation during haemodialysis The recommended dose is 100 IU/kg (1 mg/kg) of enoxaparin sodium.
Maltese: Prevenzjoni ta' formazzjoni ta' trombus matul l-emodijalisi Id-doża rrakkomandata hija 100 UI/kg (1 mg/kg) ta' enoxaparin sodium.
English: Thorinane can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI).
Maltese: Thorinanejista' 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: These anticoagulant activities are mediated through anti-thrombin III (ATIII) resulting in anti-thrombotic activities in humans.
Maltese: Dawn lattivitajiet antikoagulanti huma medjati permezz ta' antitrombin III (ATIII) li jwassal għal attivitajiet antitrombotiċi fil-bnedmin.
English: Enoxaparin sodium has shown no mutagenic activity based on in vitro tests, including the Ames test, mouse lymphoma cell forward mutation test, and no clastogenic activity based on an in vitro human lymphocyte chromosomal aberration test, and the in vivo rat bone marrow chromosomal aberration test.
Maltese: Enoxaparin ma wera l-ebda attività mutaġenika abbażi ta' testijiet in vitro, inkluż it-test Ames, test talmutazzjoni 'il quddiem taċ-ċellula tal-limfoma tal-ġurdien, u l-ebda attività klastoġenika abbażi tat-test tal-aberrazzjoni tal-kromosomi tal-limfoċita tal-bniedem in vitro, u t-test tal-aberrazzjoni tal-kromosomi tal-mudullun tal-għadam tal-far in vivo.
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: - Changing from treatment with direct oral anticoagulant to Thorinane Stop taking direct oral anticoagulant.
Maltese: - Bidla minn trattament b'antikoagulant orali dirett għal Thorinane Ieqaf ħu l-antikoagulant orali dirett.
English: : Platelet increased >400 G/L
Maltese: Żieda >400 G/L fil-plejtlits
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 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 (≥ 1/1000 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: Each mL contains 100 mg enoxaparin sodium.
Maltese: Kull mL fih 100 mg ta' enoxaparin sodium.
English: • Severe allergic reaction.
Maltese: • Reazzjoni allerġika severa.
English: These included 1,776 for prophylaxis of deep vein thrombosis following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of deep vein thrombosis in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI.
Maltese: Dawn kienu jinkludu 1,776 għall-profilassi ta' trombożi fil-vini fil-fond wara operazzjonijiet ortopediċi jew addominali f'pazjenti b'riskju ta' kumplikazzjonijiet tromboemboliċi, 1,169 għall-profilassi ta' trombożi fil-vini fil-fond f'pazjenti li jeħtieġu kura medika morda b'mod akut u b'mobilità ristretta b'mod sever, 559 għat-trattaement ta' DVT b'PE jew mingħajru, 1,578 għat-trattament ta' anġina mhux stabbli u infart mijokardijaku mingħajr mewġ Q u 10,176 għat-trattament ta' STEMI akut.
English: The patients were followed for three months.
Maltese: Iwaqqaf tagħqid tad-demm milli jifforma fid-demm tiegħek.
English: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any 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 mill-eċċipjenti elenkati fis-sezzjoni 6.1;
English: as compared to the heparin group (12.2%), representing a 17% relative risk reduction in favour of treatment with enoxaparin sodium.
Maltese: 1%) meta mqabbla mal-grupp ta' heparin (12.2%), li tirrapreżenta tnaqqis ta' 17% fir-riskju relattiv favur it-trattament b'enoxaparin sodium.
English: • Percutaneous coronary revascularization procedures
Maltese: • Proċeduri ta' rivaskularizzazzjoni koronarja perkutanja
English: Musculoskeletal, connective tissue and bone disorders • Rare: Osteoporosis* following long term therapy (greater than 3 months)
Maltese: Disturbi muskoluskeletriċi, tat-tessuti konnettivi u tal-għadam • Rari: Osteoporożi* wara terapija fit-tul (aktar minn 3 xhur)
English: Major bleeding were respectively 1.7% in the enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day group, 1.3% in the enoxaparin sodium 100 IU/kg (1 mg/kg) twice a day group and 2.1% in the heparin group.
Maltese: Fsada maġġuri kienet rispettivament 1.7% fil-grupp ta' enoxaparin sodium 150 UI/kg (1.5 mg/kg) darba kuljum, 1.3% fil-grupp ta' enoxaparin sodium 100 UI/kg (1mg/kg) darbtejn kuljum u 2.1% fil-grupp ta' heparin.
English: Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs.
Maltese: Enoxaparin sodium ma jistax jinbidel (unità għal kull unità) ma' LMWHs oħra.
English: Indication Prophylaxis of venous thromboembolic disease
Maltese: Profilassi ta' mard tromboemboliku fil-vini
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 antiinfjammatorji mhux sterojdi li jintużaw biex jittrattaw uġigħ u nefħa fl-artrite u kundizzjonijiet oħra
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 saline solution (0.9%) 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 soluzzjoni ta' normal saline (0.9%) jew 5% dextrose fl-ilma) kif ġej:
English: 2,000 IU (20 mg) SC once daily
Maltese: 2,000 UI (20 mg) SC darba kuljum
English: • In patients at moderate risk of thromboembolism, the recommended dose of enoxaparin sodium is 2,000 IU (20 mg) once daily by subcutaneous (SC) 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 (SC - subcutaneous).
English: • PE (%)
Maltese: Total ta' VTE (%)
English: • The dose will depend on how likely you are to develop a clot.
Maltese: • Id-doża tiddependi minn kemm hemm probabbiltà li inti tiżviluppa tagħqid tad-demm.
English: This study included patients with heart failure (NYHA Class III or IV); acute respiratory failure or complicated chronic respiratory insufficiency, and acute infection or acute rheumatic; if associated with at least one VTE risk factor (age ≥75 years, cancer, previous VTE, obesity, varicose veins, hormone therapy, and chronic heart or respiratory failure).
Maltese: III jew IV ta' NYHA); insuffiċjenza respiratorja akuta jew insuffiċjenza respiratorja kronika kkumplikata, u infezzjoni akuta jew rewmatika akuta; jekk kienu assoċjati ma' millinqas fattur wieħed ta' riskju għal VTE (età ≥75 sena, kanċer, VTE qabel, ħafna piż żejjed, vini varikużi, terapija bl-ormoni, u insuffiċjenza kronika tal-qalb jew insuffiċjenza respiratorja).
English: The mean maximum anti-IIa activity level is observed approximately 3 to 4 hours following SC 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: Ilmedja tal-livell tal-attività massima anti-IIa jiġi osservat madwar 3 sa 4 sigħt wara injezzjoni SC 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: How to store Thorinane
Maltese: Tużax Thorinane
English: Enoxaparin sodium is contraindicated in patients with:
Maltese: Enoxaparin sodium huwa kontraindikat f'pazjenti:
English: Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Maltese: Enoxaparin sodium jista' jingħata mingħajr periklu flimkien ma' soluzzjoni ta' normal saline (0.9%) jew 5% dextrose fl-ilma.
English: Treatment should be maintained for a minimum of 2 days and continued until clinical stabilization.
Maltese: It-trattament għandu jinżamm għal minimu ta' jumejn u jitkompla sakemm ikun hemm stabilizzazzjoni klinika.
English: • 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: • Uncommon: Local irritation, skin necrosis at injection site
Maltese: • Mhux komuni: Irritazzjoni lokali, nekroliżi tal-ġilda fil-post tal-injezzjoni
English: Appropriate antiplatelet therapy such as oral acetylsalicylic acid (75 mg to 325 mg once daily) should be administered concomitantly unless contraindicated.
Maltese: Terapija xierqa kontra l-plejtlits bħal acetylsalicylic acid mill-ħalq (75 mg sa 325 mg darba kuljum) għandha tingħata fl-istess waqt ħlief jekk tkun kontraindikata.
English: - Changing from Thorinane to treatment with direct oral anticoagulant Stop taking Thorinane.
Maltese: - Bidla minn Thorinanegħal trattament b'antikoagulant orali dirett Waqqaf Thorinane.
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: Iddoża 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 fit8 sigħat ta' qabel.
English: 6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle).
Maltese: 6) Żomm is-siringa sabiex il-labra qed tipponta 'l isfel (vertikalment f'angolu ta' 90º).
English: OTHER
Maltese: UI
English: The drug substance is the sodium salt.
Maltese: Is-sustanza tal-mediċina hija s-sodium salt.
English: Tabulated summary list of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella