FrancophonIA/ELRC3.0 huggingface dataset:
English: Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe, and in such case the volume shall be rounded up to the nearest graduation.
Croatian: Imajte na umu da u nekim slučajevima zbog oznaka na štrcaljki neće biti moguće prilagoditi volumen na točnu dozu, pa ga u tom slučaju treba zaokružiti na sljedeću najbližu oznaku.
English: • If you have problems with your kidneys you may be given a smaller amount of Thorinane.
Croatian: • Ako imate bubrežnih tegoba, možda ćete primati manju količinu lijeka Thorinane.
English: Greece
Croatian: GRČKA
English: GREECE
Croatian: Grčka
English: The skin fold should not be released until the injection is complete.
Croatian: Kožni nabor se ne smije otpustiti sve do završetka injekcije.
English: Do not start treatment with Thorinane until 12 hours after the final dose of direct oral anticoagulant.
Croatian: Nemojte početi primjenjivati Thorinane dok ne prođe najmanje 12 sati od posljednje doze direktnog oralnog antikoagulansa.
English: At higher doses, increases in activated partial thromboplastin time (aPTT), and activated clotting time (ACT) may occur.
Croatian: Kad se primjenjuje u većim dozama, može doći do produljenja aktiviranog parcijalnog tromboplastinskog vremena (aPTV) i aktiviranog vremena zgrušavanja (engl. activated clotting time, ACT).
English: • Hair loss.
Croatian: • opadanje kose
English: Make sure you can see the place you are going to inject.
Croatian: Provjerite možete li vidjeti mjesto na koje ćete si injicirati lijek.
English: These anticoagulant activities are mediated through anti-thrombin III (ATIII) resulting in anti-thrombotic activities in humans.
Croatian: U tim antikoagulacijskim aktivnostima posreduje antitrombin III (ATIII), što u ljudi dovodi do antitrombotske aktivnosti.
English: Renal clearance of active fragments represents about 10% of the administered dose and total renal excretion of active and non-active fragments 40% of the dose.
Croatian: Bubrežni klirens aktivnih fragmenata predstavlja približno 10% primijenjene doze, dok na ukupno izlučivanje aktivnih i neaktivnih fragmenata putem bubrega otpada približno 40% doze.
English: 9) Drop the used syringe with its protective sleeve into the sharps bin provided.
Croatian: 9) Iskorištenu štrcaljku zajedno s njenom zaštitnom ovojnicom bacite u predviđeni spremnik za oštre predmete.
English: If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots.
Croatian: Ako ste trudni i imate mehanički srčani zalistak, možete imati povećan rizik od nastanka krvnih ugrušaka.
English: The whole length of the needle should be introduced vertically into a skin fold gently held between the thumb and index finger.
Croatian: Iglu treba uvesti cijelom dužinom vertikalno u kožni nabor, koji treba nježno držati palcem i kažiprstom.
English: VTE = Venous thromboembolic events which included DVT, PE, and death considered to be thromboembolic in origin * p value versus placebo =0.0002
Croatian: VTE = venski tromboembolijski događaji koji su uključivali DVT, PE i smrtne slučajeve za koje se smatralo da im je uzrok tromboembolija *p-vrijednost u odnosu na placebo = 0,0002
English: After dilution the solution should be used within 8 hours.
Croatian: Nakon razrjeđivanja otopina se mora upotrijebiti unutar 8 sati.
English: o For dosage in patients ≥ 75 years of age, see paragraph “Elderly”.
Croatian: o Za doziranje u bolesnika u dobi od ≥ 75 godina, vidjeti odlomak "Starije osobe".
English: 4,716 patients underwent percutaneous coronary intervention receiving antithrombotic support with blinded study drug.
Croatian: 4716 bolesnika podvrgnuto je perkutanoj koronarnoj intervenciji uz primjenu antitrombotske potpore zaslijepljenim ispitivanim lijekom.
English: Treatment of DVT and PE
Croatian: Liječenje DVT-a i PE-a
English: • Rare: Anaphylactic/Anaphylactoid reactions including shock*
Croatian: • Rijetko: anafilaktičke/anafilaktoidne reakcije, uključujući šok*
English: If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling), consult your doctor immediately.
Croatian: Ako dođe do krvarenja koje ne prolazi samo od sebe ili ako primijetite znakove prekomjernog krvarenja (izuzetna slabost, umor, bljedilo, omaglica, glavobolja ili neobjašnjivo oticanje), odmah se obratite svom liječniku.
English: - enoxaparin sodium once a day versus heparin (-3.0 to 3.5)
Croatian: - enoksaparinnatrij jedanput na dan naspram heparina (-3,0 do 3,5)
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: Sveukupno, 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: • Decreased red blood cell count.
Croatian: • smanjen broj crvenih krvnih stanica
English: See “Do not use Thorinane”.
Croatian: Pogledajte odlomak "Nemojte primjenjivati Thorinane".
English: • Dextran injection - used as a blood replacer
Croatian: • injekciju dekstrana - koristi se kao nadomjestak krvi
English: These patients should be observed carefully for signs and symptoms of thromboembolism.
Croatian: Te bolesnike treba pažljivo nadzirati zbog moguće pojave znakova i simptoma tromboembolije.
English: Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials.
Croatian: Enoksaparinnatrij se ocjenjivao u više od 15 000 bolesnika koji su primali enoksaparinnatrij u kliničkim ispitivanjima.
English: 1) Wash your hands and the area that you will inject with soap and water.
Croatian: 1) Vodom i sapunom operite ruke i mjesto na koje ćete si injicirati lijek.
English: The SC injections of enoxaparin sodium were given until hospital discharge or for a maximum of eight days (whichever came first).
Croatian: Supkutane injekcije enoksaparinnatrija primjenjivale su se do otpusta iz bolnice ili tijekom najviše osam dana (što god je nastupilo prvo).
English: The volume of distribution of enoxaparin sodium anti-Xa activity is about 4.3 litres and is close to the blood volume.
Croatian: Volumen distribucije anti-Xa aktivnosti enoksaparinnatrija iznosi približno 4,3 litre i gotovo je jednak volumenu krvi.
English: Enoxaparin sodium is contraindicated in patients with:
Croatian: Enoksaparinnatrij je kontraindiciran u bolesnika sa:
English: • Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
Croatian: • prednizolon, deksametazon ili druge lijekove koji se koriste za liječenje astme, reumatoidnog artritisa i drugih stanja
English: If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
Croatian: Ako se posumnja na znakove ili simptome spinalnog hematoma, potrebni su hitna dijagnoza i liječenje, što uključuje i razmatranje dekompresije leđne moždine, iako takvo liječenje možda neće spriječiti ni poništiti neurološke posljedice.
English: Dose adjustment based on monitoring of anti-Xa levels is unreliable in patients with liver cirrhosis and not recommended (see section 5.2).
Croatian: Prilagodba doze na temelju praćenja razina aktivnosti anti-Xa nije pouzdana u bolesnika s cirozom jetre pa se ne preporučuje (vidjeti dio 5.2).
English: Nervous system disorders • Common: Headache*
Croatian: Poremećaji živčanog sustava • Često: glavobolja*
English: • Osteoporosis (a condition where your bones are more likely to break) after long term use.
Croatian: • osteoporoza (stanje kod kojega su kosti sklonije prijelomima) nakon dugotrajne primjene
English: If bleeding occurs, the origin of the haemorrhage should be investigated and appropriate treatment instituted.
Croatian: Ako dođe do krvarenja, treba utvrditi izvor krvarenja i uvesti odgovarajuće liječenje.
English: • When you go home, you may need to continue to use Thorinane and give it yourself (see instructions below on how to do this).
Croatian: • Nakon što Vas otpuste iz bolnice, možda ćete trebati nastaviti primjenjivati Thorinane i sami si davati injekcije (pogledajte upute o tome u nastavku).
English: The delay must be based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.
Croatian: Vremenski razmak mora se temeljiti na ocjeni koristi i rizika, uzimajući u obzir i rizik od tromboze i rizik od krvarenja u kontekstu postupka i bolesnikovih faktora rizika.
English: When used as curative treatment, aPTT can be prolonged by 1.5-2.2 times the control time at peak activity.
Croatian: Kada se koristi za kurativno liječenje, enoksaparinnatrij može produljiti aPTV 1,5 - 2,2 puta u odnosu na kontrolno vrijeme pri vršnoj aktivnosti.
English: Enoxaparin sodium treatment is prescribed for an average period of 10 days.
Croatian: Liječenje enoksaparinnatrijem u prosjeku se propisuje na 10 dana.
English: • If you are using Thorinane to treat blood clots in your body and going to receive spinal or epidural anaesthesia or lumbar puncture within 24 hours.
Croatian: • ako primjenjujete Thorinane za liječenje krvnih ugrušaka u tijelu, a primit ćete spinalnu ili epiduralnu anesteziju ili ići na lumbalnu punkciju unutar sljedeća 24 sata
English: It should not be mixed or co-administered with other medications.
Croatian: Ne smije se miješati ni primjenjivati istodobno s drugim lijekovima.
English: What Thorinane is and what it is used for What you need to know before you use Thorinane How to use Thorinane
Croatian: Što je Thorinane i za što se koristi Što morate znati prije nego počnete primjenjivati Inhixu Kako primjenjivati Inhixu
English: Concomitant use not recommended:
Croatian: Ne preporučuje se istodobna primjena:
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primijenite ovaj lijek.
English: Change the place where you inject each time from the right to the left side of your stomach.
Croatian: Svaki put mijenjajte mjesto injekcije između desne i lijeve strane trbuha.
English: Before injecting yourself with Thorinane - Check the expiry date on the medicine.
Croatian: Prije samoinjiciranja Thorinanea - Provjerite rok valjanosti lijeka.
English: Paediatric population The safety and efficacy of enoxaparin sodium in children have not been established (see section 4.2).
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost enoksaparinnatrija u djece nisu ustanovljene (vidjeti dio 4.2).
English: • - If you are allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na enoksaparinnatrij ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming (see also in section 3, “Changing of anticoagulant medicine”)
Croatian: • aspirin (poznat i kao acetilsalicilatna kiselina), klopidogrel ili druge lijekove koji se koriste za sprječavanje nastanka krvnih ugrušaka (pogledajte i odlomak "Promjena antikoagulansa" u dijelu 3.)
English: • Spinal/Epidural anaesthesia or lumbar puncture
Croatian: • Spinalna/epiduralna anestezija ili lumbalna punkcija
English: The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin).
Croatian: Odluka o primjeni enoksaparinnatrija u takvom slučaju smije se donijeti tek nakon pažljive ocjene koristi i rizika te razmatranja drugih mogućih neheparinskih terapija (npr. danaparoidnatrija ili lepirudina).
English: Based on the results of a population pharmacokinetic analysis, the enoxaparin sodium kinetic profile is not different in elderly subjects compared to younger subjects when renal function is normal.
Croatian: Prema rezultatima populacijske farmakokinetičke analize, kinetički profil enoksaparinnatrija ne razlikuje se između starijih i mlađih ispitanika ako je bubrežna funkcija normalna.
English: Make sure you hold the skin fold throughout the injection.
Croatian: Pazite da nabor kože držite za sve vrijeme injiciranja.
English: The 3,000 IU (30 mg) dose can then be directly injected into the IV line.
Croatian: Dozu od 3000 IU (30 mg) tada možete injicirati izravno u intravensku liniju.
English: All Treated DVT Patients with or without PE Total VTE (%)
Croatian: Svi liječeni bolesnici s DVT-om praćenim PE-om ili bez njega Ukupni VTE (%)
English: Elimination appears monophasic with a half-life of about 5 hours after a single SC dose to about 7 hours after repeated dosing.
Croatian: Čini se da je eliminacija jednofazna, a poluvijek se kreće u rasponu od približno 5 sati nakon jednokratne supkutane doze do približno 7 sati nakon ponovljene primjene.
English: • At the same time you will also be given Thorinane as an injection underneath your skin (subcutaneous injection).
Croatian: • Istodobno ćete Thorinane primiti i u injekcijom koja se daje pod kožu (supkutana injekcija).
English: INSTRUCTIONS FOR USE: PREFILLED SYRINGE
Croatian: UPUTE ZA UPORABU: NAPUNJENA ŠTRCALJKA
English: • Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated.
Croatian: • Lijekovi koji utječu na hemostazu (vidjeti dio 4.4) Preporučuje se da se primjena nekih lijekova koji utječu na hemostazu prekine prije uvođenja enoksaparinnatrija, osim u slučajevima u kojima je njihova primjena strogo indicirana.
English: When the quantity of drug to be injected requires to be adjusted based on the patient's body weight, use the graduated pre-filled syringes to reach the required volume by discarding the excess before injection.
Croatian: Kada količinu lijeka koja će se injicirati morate prilagoditi prema tjelesnoj težini bolesnika, upotrijebite graduiranu napunjenu štrcaljku i prilagodite volumen izbacivanjem viška prije injekcije.
English: No increased bleeding tendency is observed in the elderly with the prophylactic dosage ranges.
Croatian: U starijih osoba nije primijećena povećana sklonost krvarenju kod primjene doza iz profilaktičkog raspona.
English: Do not put it in the household rubbish.
Croatian: Nemojte ga odlagati s kućnim otpadom.
English: Store below 25 °C.
Croatian: Čuvati na temperaturi ispod 25 °C.
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: Therefore, careful clinical monitoring is advised in these patients (see section 5.2).
Croatian: Stoga se u tih bolesnika preporučuje pažljivo kliničko praćenje (vidjeti dio 5.2).
English: The syringe is pre-filled and ready to use.
Croatian: Ovo je napunjena štrcaljka i spremna je za uporabu.
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 u serumu mogu se primjenjivati istodobno s enoksaparinnatrijem uz pažljivo kliničko i laboratorijsko praćenje (vidjeti dijelove 4.4 i 4.8).
English: The anticoagulant effects can be largely neutralized by the slow IV injection of protamine.
Croatian: Antikoagulacijski učinci mogu se u velikoj mjeri neutralizirati sporom intravenskom injekcijom protamina.
English: When used as prophylactic treatment, enoxaparin sodium does not significantly affect the aPTT.
Croatian: Kada se koristi za profilaktičko liječenje, enoksaparinnatrij ne utječe značajno na aPTV.
English: Limited data are available in patients with hepatic impairment (see sections 5.1 and 5.2) and caution should be used in these patients (see section 4.4).
Croatian: Dostupni su ograničeni podaci o primjeni u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 5.1 i 5.2) i stoga je u tih bolesnika potreban oprez (vidjeti dio 4.4).
English: Packs of 2 and 10 pre-filled syringes.
Croatian: Pakiranja od 2 i 10 napunjenih štrcaljki.
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 (Child-Pugh stadij A, B i C).
English: In practice, if a confirmed significant decrease of the platelet count is observed (30 to 50 % of the initial value), enoxaparin sodium treatment must be immediately discontinued and the patient switched to another non-heparin anticoagulant alternative treatment.
Croatian: U praksi, ako se primijeti i potvrdi značajan pad broja trombocita (30 - 50% prvotne vrijednosti), liječenje enoksaparinnatrijem mora se odmah prekinuti, a bolesnika prebaciti na neku drugu, neheparinsku antikoagulacijsku terapiju.
English: Close the container lid tightly and place the container out of reach of children.
Croatian: Čvrsto zatvorite spremnik i držite ga na mjestu izvan dohvata djece.
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 (npr. pokretljivosti).
English: Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk.
Croatian: Trudnice koje primaju enoksaparinnatrij treba pažljivo pratiti kako bi se uočili mogući znakovi krvarenja ili prekomjerne antikoagulacije te ih treba upozoriti na rizik od krvarenja.
English: Water for injections
Croatian: Voda za injekciju
English: Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svakog organskog sustava nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: In surgical patients, haemorrhage complications were considered major: (1) if the haemorrhage caused a significant clinical event, or (2) if accompanied by 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: The quantitative determination of anti-Xa and anti-IIa pharmacokinetic activities was conducted by validated amidolytic methods.
Croatian: Anti-Xa i anti-IIa farmakokinetička aktivnost kvantificirala se uz pomoć validiranih amidolitičkih metoda.
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.
Croatian: Enoksaparin je heparin niske molekulske mase, srednje vrijednosti molekulske mase od približno 4500 daltona, u kojem su antitrombotska i antikoagulacijska aktivnost standardnog heparina razdvojene.
English: • Tingling, numbness and muscular weakness (particularly in the lower part of your body) when you have had a spinal puncture or a spinal anaesthetic.
Croatian: • trnci, utrnulost i mišićna slabost (osobito u donjem dijelu tijela) nakon spinalne punkcije ili primanja spinalnog anestetika
English: Animal studies did not show any effect on fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu ukazala ni na kakav učinak na plodnost (vidjeti dio 5.3).
English: SC injection Do not mix with other products.
Croatian: Supkutana injekcija Ne miješati s drugim lijekovima.
English: • If you are bleeding heavily or have a condition with a high risk of bleeding (such as stomach ulcer, recent surgery of the brain or eyes), including recent bleeding stroke.
Croatian: • ako imate teško krvarenje ili stanje kod kojega postoji visok rizik od krvarenja (kao što su čir na želucu, nedavno proveden kirurški zahvat na mozgu ili očima), uključujući nedavni moždani udar izazvan krvarenjem
English: This decrease was mainly attributed to a decrease in ATIII level secondary to a reduced synthesis of ATIII in patients with hepatic impairment.
Croatian: To se smanjenje prvenstveno pripisalo padu razine ATIII kao posljedici smanjene sinteze ATIII u bolesnika s oštećenjem jetrene funkcije.
English: Start taking the direct oral anticoagulant 0-2 hours before the time you would have had the next injection, then continue as normal.
Croatian: Počnite uzimati direktni oralni antikoagulans 0 - 2 sata prije nego što biste inače primijenili sljedeću injekciju, a zatim nastavite s liječenjem prema uobičajenom rasporedu.
English: - The other ingredient is water for injections.
Croatian: - Drugi sastojak je voda za injekciju.
English: • Uncommon: Bullous dermatitis
Croatian: • Manje često: bulozni dermatitis
English: Required dose 30 IU/kg (0.3 mg/kg)
Croatian: Potrebna doza 30 IU/kg (0,3 mg/kg)
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 300 IU/ml (3 mg/ml).
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 pokretljivost
English: • Thorinane is usually given by injection underneath the skin (subcutaneous).
Croatian: • Thorinane se obično primjenjuje injekcijom pod kožu (supkutano).
English: • SC injection technique:
Croatian: • Tehnika supkutanog injiciranja:
English: Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala dokaze fetotoksičnosti ni teratogenosti (vidjeti dio 5.3).
English: The use of a tuberculin syringe or equivalent is recommended when using ampoules or multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Croatian: Kada se koriste ampule ili višedozne bočice, preporučuje se uporaba tuberkulinske štrcaljke ili njezina ekvivalenta, kako bi se osiguralo izvlačenje odgovarajućeg volumena lijeka.
English: At doses used for prophylaxis of venous thromboembolism, enoxaparin sodium does not influence bleeding time and global blood coagulation tests significantly, nor does it affect platelet aggregation or binding of fibrinogen to platelets.
Croatian: U dozama u kojima se koristi za profilaksu venske tromboembolije, enoksaparinnatrij ne utječe značajno na vrijeme krvarenja ni opće parametre zgrušavanja krvi, a ne utječe ni na agregaciju trombocita ni na vezivanje fibrinogena za trombocite.
English: For treatment of acute STEMI in elderly patients ≥75 years of age, an initial IV bolus must not be used.
Croatian: Za liječenje akutnog STEMI-ja u starijih bolesnika u dobi od ≥ 75 godina ne smije se primijeniti početna intravenska bolusna doza.