FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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 thrombocytopeniawithin the last 100 days or if you have antibodies against enoxaparin in your blood.
Croatian: • ako ste imali reakciju na heparin koja je uzrokovala velik pad broja stanica koje zgrušavaju krv (trombocita) - ta se reakcija zove heparinom izazvana trombocitopenija - unutar posljednjih 100 dana ili ako imate protutijela na enoksaparin u krvi
English: Detailed information on this medicinal product is available on the website of {name of MS Agency (link)}
Croatian: <Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici {naziv nadležnog tijela države članice (poveznica)}>
English: Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment.
Croatian: Ako dođe do trombocitopenije, ona obično nastupa između 5. i 21. dana nakon početka liječenja enoksaparinnatrijem.
English: Paediatric population The safety and efficacy of enoxaparin sodium in children have not been established (see section 4.2).
Croatian: Sigurnost i djelotvornost enoksaparinnatrija u djece nisu ustanovljene (vidjeti dio 4.2).
English: Important information about some of the ingredients of LOVENOX (and associated names) LOVENOX (and associated names) contains benzyl alcohol [benzyl alcohol content to be completed nationally].
Croatian: Važne informacije o nekim sastojcima lijeka LOVENOX (i pridružena imena) LOVENOX (i pridružena imena) sadrži benzilni alkohol [informacije o benzilnom alkoholu ispunjava država članica].
English: It must not be used in premature babies or babies up to 1 month old due to the risk risk of severe toxicity including abnormal respiration.
Croatian: Ne smije se primjenjivati u nedonoščadi i dojenčadi mlađe od 1 mjeseca jer postoji rizik od jake toksičnosti, uključujući poremećaj disanja.
English: When non-weight adjusted dosing was administered, it was found after a single-SC 4,000 IU (40 mg) dose, that anti-Xa exposure is 52% higher in low-weight women (<45 kg) and 27% higher in lowweight men (<57 kg) when compared to normal weight control subjects (see section 4.4).
Croatian: Kod primjene doza koje nisu bile prilagođene prema tjelesnoj težini, nakon jednokratne supkutane doze od 4000 IU (40 mg) utvrđeno je da je izloženost anti-Xa aktivnosti bila 52% veća kod žena niske tjelesne težine (< 45 kg) i 27% veća kod muškaraca niske tjelesne težine (< 57 kg) u usporedbi s kontrolnim ispitanicima normalne tjelesne težine (vidjeti dio 4.4).
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često
English: LOVENOX (and associated names) works in two ways.
Croatian: LOVENOX (i pridružena imena) djeluje na dva načina.
English: Stop using LOVENOX (and associated names) and talk to a doctor or nurse at once if you get any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).
Croatian: Prestanite primjenjivati LOVENOX (i pridružena imena) i odmah se obratite liječniku ili medicinskoj sestri ako primijetite bilo koji znak teške alergijske reakcije (kao što su otežano disanje, oticanje usana,
English: • If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of LOVENOX (and associated names) each day.
Croatian: • Ako Vam je pokretljivost smanjena zbog bolesti, obično ćete svakodnevno primati 4000 IU (40 mg) lijeka LOVENOX (i pridružena imena).
English: Total VTE
Croatian: Sveukupno,
English: Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4).
Croatian: podaci pokazuju da nema dokaza povećanog rizika od krvarenja, trombocitopenije i osteoporoze u odnosu na rizik u žena koje nisu trudne, osim rizika opaženog u trudnica s umjetnim srčanim zaliscima (vidjeti dio 4.4).
English: Stopping blood clots forming in your blood in the following situations:
Croatian: Sprječavanje nastanka krvnih ugrušaka u krvi u sljedećim situacijama:
English: • When you go home, you may need to continue to use LOVENOX (and associated names) and give it yourself (see instructions below on how to do this).
Croatian: • Nakon što Vas otpuste iz bolnice, možda ćete trebati nastaviti primjenjivati LOVENOX (i pridružena imena) i sami si davati injekcije (pogledajte upute o tome u nastavku).
English: LOVENOX (and associated names) does not affect the ability to drive and operate machinery.
Croatian: LOVENOX (i pridružena imena) ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg)
Croatian: • Ako Vam je pokretljivost smanjena zbog bolesti, obično ćete svakodnevno primati 4000 IU
English: Do not inject LOVENOX (and associated names) into a muscle.
Croatian: Nemojte injicirati LOVENOX (i pridružena imena) u mišić.
English: • If you have problems with your kidneys you may be given a smaller amount of LOVENOX (and associated names).
Croatian: • Ako imate bubrežnih tegoba, možda ćete primati manju količinu lijeka LOVENOX (i pridružena imena).
English: The incidence of DVT during extended prophylaxis was significantly lower for enoxaparin sodium compared to placebo, no PE was reported.
Croatian: Incidencija DVT-a tijekom produljene profilakse bila je značajno niža uz enoksaparinnatrij nego uz placebo, a nije prijavljen nijedan slučaj
English: Based on literature data the use of enoxaparin sodium 4,000 IU (40 mg) in cirrhotic patients (ChildPugh class B-C) appears to be safe and effective in preventing portal vein thrombosis.
Croatian: Prema podacima iz literature, čini se da je primjena enoksaparinnatrija u dozi od 4000 IU (40 mg) u bolesnika s cirozom (Child-Pugh stadij B-C) sigurna i učinkovita za sprječavanje tromboze portalne vene.
English: o For patients who undergo major orthopaedic surgery an extended thromboprophylaxis up to 5 weeks is recommended.
Croatian: Za bolesnike koji se podvrgavaju velikom ortopedskom kirurškom zahvatu preporučuje se produljena tromboprofilaksa u trajanju do 5 tjedana.
English: If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is used, tell you doctor that you are using LOVENOX (and associated names).
Croatian: Ako trebate ići na spinalnu punkciju ili operaciju kod koje se koristi epiduralna ili spinalna anestezija, recite svom liječniku da primjenjujete LOVENOX (i pridružena imena).
English: How to store LOVENOX (and associated names) [To be completed nationally] Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati LOVENOX (i pridružena imena) [Ispunjava država članica] Lijek čuvajte izvan pogleda i dohvata djece.
English: - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants.
Croatian: - ostali trombolitici (npr. alteplaza, reteplaza, streptokinaza, tenekteplaza, urokinaza) i antikoagulansi
English: Intracranial haemorrhage, Retroperitoneal haemorrhage
Croatian: intrakranijalno krvarenje, retroperitonejsko krvarenje
English: • Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming
Croatian: • aspirin (poznat i kao acetilsalicilatna kiselina), klopidogrel ili druge lijekove koji se koriste za sprječavanje nastanka krvnih ugrušaka
English: Prophylaxis of venous thromboembolic disease in medical patients with an acute illness expected to induce limitation of mobility
Croatian: Profilaksa venske tromboembolijske bolesti u medikamentozno liječenih bolesnika s akutnom bolešću za koju se očekuje da će ograničiti pokretljivosti
English: • are currently using medicines which affect bleeding (see section below - “Other medicines”).
Croatian: • ako trenutno uzimate lijekove koji utječu na krvarenje (pogledajte odlomak o primjeni drugih lijekova u nastavku)
English: Besides the anticoagulant effects of enoxaparin sodium, there was no evidence of adverse effects at 15 mg/kg/day in the 13-week SC toxicity studies both in rats and dogs and at 10 mg/kg/day in the 26week SC and IV toxicity studies both in rats, and monkeys.
Croatian: Osim antikoagulacijskih učinaka enoksaparinnatrija, nije bilo dokaza štetnih učinaka pri dozi od 15 mg/kg na dan u 13-tjednom ispitivanju toksičnosti supkutane primjene ni u štakora ni u pasa, te pri dozi od 10 mg/kg na dan u 26-tjednom ispitivanju toksičnosti supkutane i intravenske primjene ni u štakora ni u majmuna.
English: It may cause toxic and allergic reactions in infants up to 3 years old.
Croatian: To je konzervans koji može uzrokovati toksične i alergijske reakcije u djece u dobi do 3 godine.
English: Treatment with enoxaparin sodium is prescribed for at least 6 to 14 days whatever the recovery status (e.g. mobility).
Croatian: Liječenje enoksaparinnatrijem propisuje se na najmanje 6 do 14 dana, neovisno o statusu oporavka
English: swelling of your lips, face, throat or tongue.
Croatian: usta, grla ili očiju).
English: Prophylaxis in medical patients
Croatian: Profilaksa u medikamentozno liječenih bolesnika
English: What you need to know before you use LOVENOX (and associated names)
Croatian: Što morate znati prije nego počnete primjenjivati LOVENOX (i pridružena imena)
English: • An initial dose of 3,000 IU (30 mg) of LOVENOX (and associated names) will be given as injection into your vein.
Croatian: • Primit ćete početnu dozu od 3000 IU (30 mg) lijeka LOVENOX (i pridružena imena) injekcijom u venu.
English: - Changing from treatment with direct oral anticoagulant to LOVENOX (and associated names) Stop taking direct oral anticoagulant.
Croatian: - Prelazak s liječenja direktnim oralnim antikoagulansima na LOVENOX (i pridružena imena) Prestanite uzimati direktni oralni antikoagulans.
English: • If you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
Croatian: • ako ste alergični na heparin ili druge heparine niske molekulske mase, kao što su nadroparin,
English: No pharmacokinetic interactions were observed between enoxaparin sodium and thrombolytics when administered concomitantly.
Croatian: Farmakokinetičke interakcije Nisu primijećene farmakokinetičke interakcije između enoksaparinnatrija i trombolitika pri njihovoj istodobnoj primjeni.
English: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).
Croatian: • Lijekovi koji povisuju razinu kalija: Lijekovi koji povisuju razinu kalija u serumu mogu se primjenjivati istodobno s enoksaparinnatrijem uz pažljivo kliničko i laboratorijsko praćenje (vidjeti dijelove 4.4 i 4.8).
English: Your doctor will request you perform blood tests called INR and tell you when to stop LOVENOX (and associated names) accordingly.
Croatian: Vaš će liječnik tražiti da napravite krvne pretrage za određivanje parametra koji se zove INR i reći će Vam kada trebate prestati primjenjivati LOVENOX (i pridružena imena) u skladu s nalazima tih pretraga.
English: In surgical patients, haemorrhage complications were considered major: (1) if the haemorrhage caused a significant clinical event, or (2) if accompanied by a haemoglobin decrease ≥ 2 g/dL or transfusion of 2 or more units of blood products.
Croatian: U kirurških su se bolesnika komplikacije krvarenja smatrale velikima: (1) ako je krvarenje uzrokovalo značajan klinički događaj ili (2) ako je krvarenje bilo praćeno padom vrijednosti hemoglobina za ≥ 2 g/dl ili transfuzijom 2 ili više jedinica krvnih pripravaka.
English: You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of LOVENOX (and associated names) each day.
Croatian: Svaki ćete dan primati 2000 IU (20 mg) ili 4000 IU (40 mg) lijeka LOVENOX (i pridružena imena).
English: • Acute coronary syndrome: - Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
Croatian: • akutni koronarni sindrom: - liječenje nestabilne angine pektoris i infarkta miokarda bez elevacije ST-segmenta (engl. non-ST segment elevation myocardial infarction, NSTEMI), u kombinaciji s peroralnom primjenom acetilsalicilatne kiseline
English: How to store LOVENOX (and associated names) Contents of the pack and other information
Croatian: Kako čuvati LOVENOX (i pridružena imena) Sadržaj pakiranja i druge informacije
English: These factors are known to contribute to the overall anti-thrombotic effect of enoxaparin sodium.
Croatian: Poznato je da ti faktori pridonose sveukupnom antitrombotskom učinku enoksaparinnatrija.
English: • you have high blood pressure
Croatian: • ako ste nedavno pretrpjeli moždani udar • ako imate visok krvni tlak
English: LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL is used to stop blood clots forming in the tubes of your dialysis machine (used for people with severe kidney problems).
Croatian: LOVENOX (i pridružena imena) 10 000 IU (100 mg)/10 ml koristi se za sprječavanje nastanka krvnih ugrušaka u cijevima uređaja za dijalizu (koji se koristi u osoba s teškim bubrežnim tegobama).
English: • For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by a SC injection.
Croatian: • Kod akutnog STEMI-ja, liječenje treba započeti jednokratnom intravenskom bolusnom injekcijom, nakon koje se odmah primjenjuje supkutana injekcija.
English: If you receive more LOVENOX (and associated names) than you should If you think that you have received too much or too little LOVENOX (and associated names), tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem.
Croatian: Ako primite više lijeka LOVENOX (i pridružena imena) nego što ste trebali Ako mislite da ste primili previše ili premalo lijeka LOVENOX (i pridružena imena), odmah se obratite svom liječniku, medicinskoj sestri ili ljekarniku, čak i ako nemate znakova tegoba.
English: Caution should be used in patients with hepatic impairment as these patients have an increased potential for bleeding (see section 4.4) and no formal dose finding studies have been performed in cirrhotic patients (Child Pugh class A, B nor C).
Croatian: Potreban je oprez u bolesnika s oštećenjem jetrene funkcije jer u tih bolesnika postoji povećana mogućnost krvarenja (vidjeti dio 4.4), a nisu provedena formalna ispitivanja utvrđivanja doze u bolesnika s cirozom
English: If you use more LOVENOX (and associated names) than you should If you think that you have used too much or too little LOVENOX (and associated names), tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem.
Croatian: Ako primijenite više lijeka LOVENOX (i pridružena imena) nego što ste trebali Ako mislite da ste primijenili previše ili premalo lijeka LOVENOX (i pridružena imena), odmah se obratite svom liječniku, medicinskoj sestri ili ljekarniku, čak i ako nemate znakova tegoba.
English: As there is an interval before the VKA reaches its maximum effect, enoxaparin sodium therapy should be continued at a constant dose for as long as necessary in order to maintain the INR within the desired therapeutic range for the indication in two successive tests.
Croatian: liječenje enoksaparinom treba nastaviti u stalnoj dozi onoliko dugo koliko je potrebno da se INR održi unutar željenog terapijskog raspona za određenu indikaciju u dva uzastopna testa.
English: • At the same time you will also be given LOVENOX (and associated names) as an injection underneath your skin (subcutaneous injection).
Croatian: • Istodobno ćete LOVENOX (i pridružena imena) primiti i u injekcijom koja se daje pod kožu (supkutana injekcija).
English: Benzyl alcohol may also cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Croatian: Benzilni alkohol također može izazvati toksične reakcije i anafilaktoidne reakcije u dojenčadi i djece u dobi do
English: After repeated SC 150 IU/kg (1.5 mg/kg) once daily dosing, mean AUC of anti-Xa activity is marginally higher at steady state in obese healthy volunteers (BMI 30-48 kg/m2) compared to nonobese control subjects, while maximum plasma anti-Xa activity level is not increased.
Croatian: Nakon ponovljene primjene supkutane doze od 150 IU/kg (1,5 mg/kg) jedanput na dan, srednja vrijednost AUC-a anti-Xa aktivnosti u stanju dinamičke ravnoteže bila je neznatno viša u pretilih zdravih dobrovoljaca (ITM: 30 - 48 kg/m2) nego u nepretilih kontrolnih ispitanika, dok vršna plazmatska anti-Xa aktivnost nije bila povećana.
English: The administration of medicinal product containing benzyl alcohol as a preservative to neonates has been associated with a fatal “Gasping Syndrome” (see section 4.3).
Croatian: Primjena lijeka koji sadrži benzilni alkohol kao konzervans u novorođenčadi povezan je sa smrtonosnim "sindromom dahtanja" (vidjeti dio 4.3).
English: injection.
Croatian: injekcijom u venu.
English: • LOVENOX (and associated names) is added to the tube leaving the body (arterial line) at the start of the dialysis session.
Croatian: • LOVENOX (i pridružena imena) se dodaje u cijev koja izlazi iz tijela (arterijsku liniju) na početku dijalize.
English: Do not expel the air bubble from the syringe before the injection to avoid the loss of drug when using pre-filled syringes.
Croatian: Kako ne bi došlo do gubitka lijeka kod uporabe napunjenih štrcaljki, nemojte prije primjene injekcije uklanjati mjehurić zraka iz štrcaljke.
English: • Your doctor will decide how long you should receive LOVENOX (and associated names).
Croatian: • Vaš će liječnik odrediti koliko dugo trebate primati LOVENOX (i pridružena imena).
English: INFORMATION IN BRAILLE LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen
Croatian: 16. PODACI NA BRAILLEOVOM PISMU LOVENOX 10 x 4000 IU (10 x 40 mg) brizgalica
English: In these patients, careful clinical monitoring is advised, and biological monitoring by anti-Xa activity measurement might be considered (see section 5.2).
Croatian: U tih se bolesnika preporučuje pažljivo kliničko praćenje, a može se razmotriti i biološko praćenje određivanjem anti-Xa aktivnosti (vidjeti dio 5.2).
English: Enoxaparin
Croatian: enoksaparin
English: Common: Thrombocytosis β
Croatian: trombocitoza β
English: Not all pack sizes may be marketed.
Croatian: [Ispunjava država članica] Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH), to benzyl alcohol or to any of the excipients listed in section 6.1;
Croatian: • preosjetljivošću na enoksaparinnatrij, heparin ili njegove derivate, uključujući druge heparine niske molekulske mase, benzilni alkohol ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: OUTER BOX PRE FILLED SYRINGE
Croatian: KUTIJA NAPUNJENE ŠTRCALJKE
English: • Pregnant women with mechanical prosthetic heart valves The use of enoxaparin sodium for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied.
Croatian: • Trudnice s mehaničkim umjetnim srčanim zaliscima Primjena enoksaparinnatrija za tromboprofilaksu u trudnica s mehaničkim umjetnim srčanim zaliscima nije adekvatno ispitana.
English: Should the physician decide to administer anticoagulation in the context of epidural or spinal anaesthesia/analgesia or lumbar puncture, frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits
Croatian: Ako liječnik odluči primijeniti antikoagulans u kontekstu epiduralne ili spinalne anestezije/analgezije ili lumbalne punkcije, moraju se provoditi česte kontrole kako bi se uočili bilo kakvi znakovi i simptomi neuroloških oštećenja, kao što su bol u središnjem dijelu leđa, senzorni i motorički deficiti
English: This medicinal product is authorised in the Member States of the EEA under the following names: {Name of the Member State} {Name of the medicinal product} {Name of the Member State} {Name of the medicinal product} [See Annex I - To be completed nationally] [For referral procedures, as appropriate] This leaflet was last revised in {MM/YYYY} {month YYYY}.
Croatian: - Ispunjava država članica] [za arbitražne postupke, kako je prikladno] Ova uputa je zadnji puta revidirana u {MM/GGGG} {mjesec GGGG}.
English: - cramping pain, redness, warmth, or swelling in one of your legs - these are symptoms of deep vein thrombosis - breathlessness, chest pain, fainting or coughing up blood - these are symptoms of a pulmonary embolism
Croatian: - bolni grčevi, crvenilo, toplina ili oticanje jedne noge - to su simptomi duboke venske tromboze - nedostatak zraka, bol u prsnom košu, nesvjestica ili iskašljavanje krvi - to su simptomi plućne embolije
English: Very rare:
Croatian: Vrlo često:
English: LOVENOX (and associated names) should not be used interchangeably with other medicines belonging to the group of low molecular weight heparins.
Croatian: LOVENOX (i pridružena imena) se ne smije međusobno zamjenjivati s drugim lijekovima iz skupine heparina niske molekulske mase.
English: Changing of anticoagulant treatment - Changing from LOVENOX (and associated names) to blood thinners called vitamin-K antagonists (e.g. warfarin)
Croatian: - Prelazak s lijeka LOVENOX (i pridružena imena) na lijekove za razrjeđivanje krvi koji se zovu antagonisti vitamina K (npr. varfarin)
English: • LOVENOX (and associated names) is usually given by injection underneath the skin (subcutaneous).
Croatian: • LOVENOX (i pridružena imena) se obično primjenjuje injekcijom pod kožu (supkutano).
English: LOVENOX (and associated names) can be used during breastfeeding.
Croatian: LOVENOX (i pridružena imena) se može primjenjivati tijekom dojenja.
English: (subcutaneous).
Croatian: (npr. pokretljivosti).
English: o For patients with a high venous thromboembolism (VTE) risk who undergo abdominal or pelvic surgery for cancer an extended thromboprophylaxis up to 4 weeks is recommended.
Croatian: Za bolesnike s visokim rizikom od venske tromboembolije (VTE) koji se podvrgavaju onkološkom kirurškom zahvatu u abdomenu ili zdjelici preporučuje se produljena tromboprofilaksa u trajanju do 4 tjedna.
English: it is administered through the arterial line of a dialysis circuit.
Croatian: enoksaparinnatrij se primjenjuje kroz arterijsku liniju sustava za dijalizu.
English: • Extended prophylaxis of DVT following cancer surgery A double-blind, multicenter trial, compared a four-week and a one-week regimen of enoxaparin sodium prophylaxis in terms of safety and efficacy in 332 patients undergoing elective surgery for abdominal or pelvic cancer.
Croatian: Dvostruko slijepo, multicentrično ispitivanje uspoređivalo je sigurnost i djelotvornost četverotjednog i jednotjednog režima profilakse enoksaparinnatrijem u 332 bolesnika podvrgnuta elektivnom onkološkom kirurškom zahvatu u abdomenu ili zdjelici.
English: All Treated DVT Patients with or without PE Total VTE (%)
Croatian: PE-om ili bez njega Ukupni VTE (%)
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.
Croatian: Doza protamina ovisi o injiciranoj dozi enoksaparinnatrija; ako je enoksaparinnatrij primijenjen unutar prethodnih 8 sati, 1 mg protamina neutralizira antikoagulacijski učinak 100 IU