FrancophonIA/ELRC3.0 huggingface dataset:
English: These included 1,776 for prophylaxis of deep vein thrombosis (DVT) 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 pulmonary embolism (PE), 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI.
Croatian: nakon ortopedskog ili abdominalnog kirurškog zahvata u bolesnika s rizikom od tromboembolijskih komplikacija, 1169 slučajeva profilakse duboke venske tromboze u medikamentozno liječenih bolesnika s akutnom bolešću i izuzetno ograničenom pokretljivošću, 559 slučajeva liječenja DVT-a praćenog plućnom embolijom (PE) ili bez nje, 1578 slučajeva liječenja nestabilne angine i infarkta miokarda bez Q-zupca te 10 176 slučajeva liječenja akutnog STEMI-ja.
English: One vial contains enoxaparin sodium 100,000 IU anti-Xa activity (equivalent to 1000 mg) + 150 mg benzyl alcohol in 10.0 mL water for injections.
Croatian: Jedna bočica sadrži 100 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 1000 mg) + 150 mg benzilnog alkohola u 10,0 ml vode za injekcije.
English: If you forget to use LOVENOX (and associated names) If you forget to give yourself a dose, have it as soon as you remember.
Croatian: Ako zaboravite primijeniti dozu, primijenite je čim se sjetite.
English: Pre-Filled Syringes:
Croatian: Napunjene štrcaljke:
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).
Croatian: (i.v.) bolus od 3000 IU (30 mg) plus supkutana doza od 100 IU/kg (1 mg/kg), nakon koje slijedi supkutana primjena doze od 100 IU/kg (1 mg/kg) svakih 12 sati (najviše 10 000 IU (100 mg) za svaku od prve dvije supkutane doze).
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).
Croatian: - enoksaparinnatrij jedanput na dan naspram heparina (-3,0 do 3,5) - enoksaparinnatrij svakih 12 sati naspram heparina (-4,2 do 1,7)
English: SPECIAL STORAGE CONDITIONS [to be completed nationally]
Croatian: POSEBNE MJERE ČUVANJA [Ispunjava država članica]
English: R
Croatian: o
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial (10.0 mL) contains 10,000 IU (100 mg) enoxaparin sodium.
Croatian: Jedna bočica (10,0 ml) sadrži 10 000 IU (100 mg) enoksaparinnatrija
English: LMWHs are biological medicinal products.
Croatian: Heparini niske molekulske mase su biološki lijekovi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX MULTIDOSE VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA BRIZGALICE
English: After repeated SC administration of 4,000 IU (40 mg) once daily and 150 IU/kg (1.5 mg/kg) once daily regimens in healthy volunteers, the steady-state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose.
Croatian: (1,5 mg/kg) jedanput na dan u zdravih dobrovoljaca, stanje dinamičke ravnoteže postiže se 2. dana, uz prosječan omjer izloženosti koji je približno 15% veći nego nakon jednokratne doze.
English: Package leaflet: Information for the user LOVENOX (and associated names) 10 x 4,000 IU (10 x 40 mg) doses solution for injection in a pen [See Annex I - To be completed nationally] enoxaparin sodium
Croatian: Uputa o lijeku: Informacije za korisnika LOVENOX (i pridružena imena) 10 x 4000 IU (10 x 40 mg) otopina za injekciju u brizgalici
English: One vial contains enoxaparin sodium 30,000 IU anti-Xa activity (equivalent to 300 mg) + 45 mg benzyl alcohol in 3.0 mL water for injections.
Croatian: Jedna bočica sadrži 30 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 300 mg) + 45 mg benzilnog alkohola u 3,0 ml vode za injekcije.
English: The usual dose is 100 IU (1 mg) for every kilogram of your weight.
Croatian: Uobičajena doza je 100 IU (1 mg) po kilogramu tjelesne težine.
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 (1mg/kg) twice a day group and 2.1% in the heparin group.
Croatian: Stopa velikih krvarenja iznosila je 1,7% u skupini liječenoj enoksaparinnatrijem u dozi od 150 IU/kg (1,5 mg/kg) jedanput na dan, 1,3% u skupini liječenoj enoksaparinnatrijem u dozi od 100 IU/kg
English: What LOVENOX (and associated names) contains
Croatian: LOVENOX (i pridružena imena)
English: [To be completed nationally] [See Annex I - To be completed nationally] [For referral procedures]
Croatian: - Ispunjava država članica] [za arbitražne postupke]
English: One pre-filled syringe (0.2 mL) contains 2,000 IU (20 mg) enoxaparin sodium One pre-filled syringe (0.4 mL) contains 4,000 IU (40 mg) enoxaparin sodium One pre-filled syringe (0.6 mL) contains 6,000 IU (60 mg) enoxaparin sodium One pre-filled syringe (0.8 mL) contains 8,000 IU (80 mg) enoxaparin sodium One pre-filled syringe (0.8 mL) contains 12,000 IU (120 mg) enoxaparin sodium One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium One pre-filled syringe (1 mL) contains 15,000 IU (150 mg) enoxaparin sodium
Croatian: Jedna napunjena štrcaljka (0,2 ml) sadrži 2000 IU (20 mg) enoksaparinnatrija Jedna napunjena štrcaljka (0,4 ml) sadrži 4000 IU (40 mg) enoksaparinnatrija Jedna napunjena štrcaljka (0,6 ml) sadrži 6000 IU (60 mg) enoksaparinnatrija Jedna napunjena štrcaljka (0,8 ml) sadrži 8000 IU (80 mg) enoksaparinnatrija Jedna napunjena štrcaljka (0,8 ml) sadrži 12 000 IU (120 mg) enoksaparinnatrija Jedna napunjena štrcaljka (1 ml) sadrži 10 000 IU (100 mg) enoksaparinnatrija Jedna napunjena štrcaljka (1 ml) sadrži 15 000 IU (150 mg) enoksaparinnatrija
English: Very common: Thrombocytosisβ Common:
Croatian: Vrlo rijetko: imunoalergijska trombocitopenija
English: How to use LOVENOX (and associated names) Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: • LOVENOX (i pridružena imena) obično će Vam dati liječnik ili medicinska sestra.
English: After 12 hours of the enoxaparin sodium injection, protamine administration may not be required.
Croatian: Ako je od injekcije enoksaparinnatrija prošlo 12 sati,
English: Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for ST-segment elevation myocardial infarction (STEMI) (see section 5.2).
Croatian: U bolesnika starijih od 75 godina koji se liječe zbog infarkta miokarda s elevacijom ST-segmenta (engl.
English: - Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to LOVENOX (and associated names)
Croatian: - Prelazak s lijekova za razrjeđivanje krvi koji se zovu antagonisti vitamina K (npr. varfarin) na
English: The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting haemostasis such as NonSteroidal-Anti Inflammatory Drugs (NSAIDs), with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity.
Croatian: istodobne primjene dodatnih lijekova koji utječu na hemostazu, poput nesteroidnih protuupalnih lijekova (NSAIL), traumatske ili ponovljene epiduralne ili spinalne punkcije, kao i u bolesnika koji u anamnezi imaju kirurški zahvat na kralježnici ili deformaciju kralježnice.
English: Each prefilled syringe contains enoxaparin sodium 12,000 IU anti-Xa activity (equivalent to 120 mg) in 0.8 mL water for injections.
Croatian: Jedna napunjena štrcaljka sadrži 12 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 120 mg) u 0,8 ml vode za injekcije.
English: All Treated DVT Patients with or without PE
Croatian: Svi liječeni bolesnici s DVT-om praćenim
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).
Croatian: 7 - 10 dana, neovisno o statusu oporavka (npr. pokretljivosti).
English: Treatment of unstable angina and non ST elevation myocardial infarction In a large multicenter study, 3,171 patients enrolled at the acute phase of unstable angina or non-Qwave myocardial infarction were randomized to receive in association with acetylsalicylic acid (100 to 325 mg once daily), either SC enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours or IV unfractionated heparin adjusted based on aPTT.
Croatian: Liječenje nestabilne angine i infarkta miokarda bez elevacije ST-segmenta U velikom multicentričnom ispitivanju sudjelovao je 3171 bolesnik uključen u ispitivanje u akutnoj fazi nestabilne angine ili infarkta miokarda bez Q-zupca.
English: • Traceability
Croatian: • Sljedivost
English: Each ampoule contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections.
Croatian: Jedna ampula sadrži 10 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 100 mg) u 1,0 ml vode za injekcije.
English: Marketing Authorisation Holder and Manufacturer
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač [Ispunjava država članica]
English: Each prefilled syringe contains enoxaparin sodium 15,000 IU anti-Xa activity (equivalent to 150 mg) in 1.0 mL water for injections.
Croatian: Jedna napunjena štrcaljka sadrži 15 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 150 mg) u 1,0 ml vode za injekcije.
English: LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg)/0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection
Croatian: LOVENOX (i pridružena imena) 2000 IU (20 mg)/0,2 ml otopina za injekciju LOVENOX (i pridružena imena) 4000 IU (40 mg)/0,4 ml otopina za injekciju LOVENOX (i pridružena imena) 6000 IU (60 mg)/0,6 ml otopina za injekciju LOVENOX (i pridružena imena) 8000 IU (80 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju
English: LOVENOX (and associated names) 10 x 4,000 IU (10 x 40 mg) solution for injection [See Annex I - To be completed nationally]
Croatian: NAZIV LIJEKA LOVENOX (i pridružena imena) 10 x 4000 IU (10 x 40 mg) otopina za injekciju
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.
Croatian: Kod liječenja DVT-a praćenog PE-om ili bez njega, bolesnici su primali enoksaparinnatrij u supkutanoj dozi od 100 IU/kg (1 mg/kg) svakih
English: A puncture-free interval of at least 12 hours shall be kept between the last injection of enoxaparin sodium at prophylactic doses and the needle or catheter placement.
Croatian: Između posljednje injekcije enoksaparinnatrija u profilaktičkim dozama i uvođenja igle ili katetera mora proći razdoblje od najmanje 12 sati bez ikakvih uboda.
English: • 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) SC, were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n=90) once a day SC or to placebo (n=89) for 3 weeks.
Croatian: U dvostruko slijepom ispitivanju produljene profilakse u bolesnika podvrgnutih kirurškom zahvatu zamjene kuka, 179 bolesnika bez venske tromboembolijske bolesti, koji su prvotno (tijekom hospitalizacije) bili liječeni enoksaparinnatrijem u supkutanoj dozi od 4000 IU (40 mg),
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).
Croatian: Kao i svaki drugi antikoagulans, enoksaparinnatrij mora se primjenjivati uz oprez kod stanja kod kojih postoji povećan rizik od krvarenja, kao što su: - poremećaj hemostaze - peptički ulkus u anamnezi
English: What is in this leaflet
Croatian: Pogledajte odlomak
English: (20 mg) or 4,000 IU (40 mg) of LOVENOX (and associated names) each day.
Croatian: (40 mg) lijeka LOVENOX (i pridružena imena).
English: If you get any side effects, talk to your doctor orpharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: L [to be completed nationally]
Croatian: - Ispunjava država članica]
English: Your doctor will decide how much LOVENOX (and associated names) to give you.
Croatian: Vaš će liječnik odrediti koliko ćete lijeka LOVENOX (i pridružena imena) primati.
English: • Your doctor will decide how much LOVENOX (and associated names) to give you.
Croatian: • Vaš će liječnik odrediti koliko ćete lijeka LOVENOX (i pridružena imena) primati.
English: Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin-induced thrombocytopenia without circulating antibodies.
Croatian: Enoksaparinnatrij se mora primjenjivati uz osobit oprez u bolesnika koji u anamnezi (> 100 dana)
English: LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg)/0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection LOVENOX (and associated names) 30,000 IU (300 mg)/3 mL solution for injection LOVENOX(and associated names) 50,000 IU (500 mg)/5 mL solution for injection LOVENOX(and associated names) 100,000 IU (1,000 mg)/10 mL solution for injection LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection
Croatian: LOVENOX (i pridružena imena) 2000 IU (20 mg)/0,2 ml otopina za injekciju LOVENOX (i pridružena imena) 4000 IU (40 mg)/0,4 ml otopina za injekciju LOVENOX (i pridružena imena) 6000 IU (60 mg)/0,6 ml otopina za injekciju LOVENOX (i pridružena imena) 8000 IU (80 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju LOVENOX (i pridružena imena) 30 000 IU (300 mg)/3 ml otopina za injekciju LOVENOX (i pridružena imena) 50 000 IU (500 mg)/5 ml otopina za injekciju LOVENOX (i pridružena imena) 100 000 IU (1000 mg)/10 ml otopina za injekciju LOVENOX (i pridružena imena) 12 000 IU (120 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 15 000 IU (150 mg)/1 ml otopina za injekciju
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL solution for injection [See Annex I - To be completed nationally]
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA LOVENOX (i pridružena imena) 10 000 IU (100 mg)/10 ml otopina za injekciju
English: PE, treatment of unstable angina and NSTEMI, enoxaparin sodium is administered by SC
Croatian: • Za liječenje nestabilne angine i NSTEMI-ja, preporučena doza enoksaparinnatrija je 100 IU/kg
English: Immuno-allergic thrombocytopeni a
Croatian: trombocitoza β, trombocitopenija
English: Prevention of thrombus formation during haemodialysis The recommended dose is 100 IU/kg (1 mg/kg) of enoxaparin sodium.
Croatian: Preporučena doza je 100 IU/kg (1 mg/kg) enoksaparinnatrija.
English: • LOVENOX (and associated names) can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
Croatian: • Nakon određenih vrsta srčanog udara ili operacija, LOVENOX (i pridružena imena) se može primijeniti injekcijom u venu (intravenski). • LOVENOX (i pridružena imena) se može dodati u cijev koja izlazi iz tijela (arterijsku liniju) na početku dijalize.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection [to be completed nationally]
Croatian: OBLIK I SADRŽAJ Otopina za injekciju
English: • For the prophylaxis of venous thrombo-embolic disease following surgery, treatment of DVT and
Croatian: • Produljena profilaksa venske tromboembolije (VTE) nakon ortopedskog kirurškog zahvata
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BRIZGALICA
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection [See Annex I - To be completed nationally] enoxaparin
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju
English: • Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
Croatian: a koriste se za liječenje boli i oticanja kod artritisa i drugih bolesti • prednizolon, deksametazon ili druge lijekove koji se koriste za liječenje astme, reumatoidnog artritisa i drugih stanja • lijekove koji povisuju razinu kalija u krvi, kao što su soli kalija, tablete za izmokravanje
English: In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute
Croatian: U kliničkim ispitivanjima primjene za liječenje nestabilne angine i infarkta miokarda bez Q-zupca, doza je iznosila 100 IU/kg
English: LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg /0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection
Croatian: LOVENOX (i pridružena imena) 2000 IU (20 mg)/0,2 ml otopina za injekciju LOVENOX (i pridružena imena) 4000 IU (40 mg)/0,4 ml otopina za injekciju LOVENOX (i pridružena imena) 6000 IU (60 mg)/0,6 ml otopina za injekciju LOVENOX (i pridružena imena) 8000 IU (80 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju LOVENOX (i pridružena imena) 12 000 IU (120 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 15 000 IU (150 mg)/1 ml otopina za injekciju
English: NAME OF THE MEDICINAL PRODUCT LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL solution for injection [See Annex I - To be completed nationally] Enoxaparin
Croatian: NAZIV LIJEKA LOVENOX (i pridružena imena) 10 000 IU (100 mg)/10 ml otopina za injekciju
English: Intracranial haemorrhage,
Croatian: Ako se provodi ručna kompresija,
English: Overall list of possible side effects: Very common ( may affect more than 1 in 10 people)
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba)
English: LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg)/0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection [See Annex I - To be completed nationally]
Croatian: LOVENOX (i pridružena imena) 2000 IU (20 mg)/0,2 ml otopina za injekciju LOVENOX (i pridružena imena) 4000 IU (40 mg)/0,4 ml otopina za injekciju LOVENOX (i pridružena imena) 6000 IU (60 mg)/0,6 ml otopina za injekciju LOVENOX (i pridružena imena) 8000 IU (80 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju LOVENOX (i pridružena imena) 12 000 IU (120 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 15 000 IU (150 mg)/1 ml otopina za injekciju enoksaparin
English: All patients also received warfarin sodium (dose adjusted according to prothrombin time to achieve an International Normalized Ratio (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.
Croatian: Svi su bolesnici primali i varfarinnatrij (doza se prilagođavala prema protrombinskom vremenu radi postizanja internacionalnog normaliziranog omjera (engl. international normalized ratio, INR) od
English: Tabulated summary list of adverse reactions
Croatian: Tablični prikaz nuspojava
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) IV dose however, AUC was two-fold higher than control.
Croatian: Nakon jednokratne intravenske doze od 25 IU (0,25 mg/kg), 50 IU (0,50 mg/kg) ili 100 IU/kg
English: Skin necrosis and cutaneous vasculitis have been reported with LMWHs and should lead to prompt treatment discontinuation.
Croatian: • Nekroza kože / kožni vaskulitis Kod primjene heparina niske molekulske mase prijavljeni su nekroza kože i kožni vaskulitis, koji zahtijevaju trenutačan prekid liječenja.
English: Although no dose adjustment is recommended in patients with moderate (creatinine clearance 3050 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, careful clinical monitoring is advised.
Croatian: 30 - 50 ml/min) i blagim (klirens kreatinina: 50 - 80 ml/min) oštećenjem bubrežne funkcije,
English: These are more likely to appear in the area you have been injected with LOVENOX (and associated names).
Croatian: Moguće nuspojave Kako čuvati LOVENOX (i pridružena imena)
English: In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 300 IU/mL (3 mg/mL).
Croatian: Da bi se osigurala točnost malog volumena koji treba injicirati, preporučuje se razrijediti lijek do
English: One vial contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 10 mL water for injections.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 10 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 100 mg) u 10 ml vode za injekcije.
English: LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL solution for injection [See Annex I - To be completed nationally]
Croatian: NAZIV LIJEKA LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju
English: LOVENOX (and associated names) can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non-STEMI (NSTEMI).
Croatian: ST-segment elevation myocardial infarction, STEMI) ili infarkt miokarda bez elevacije ST-segmenta (engl. non-ST segment elevation myocardial infarction, NSTEMI).
English: The tablet should be swallowed whole with a little water.
Croatian: Tabletu treba progutati cijelu uz malo vode.
English: The usual dose of Tandemact is one tablet once a day, taken just before or with the first meal of the day.
Croatian: Uobičajena doza lijeka Tandemact je jedna tableta na dan, neposredno prije ili tijekom prvog dnevnog obroka.