FrancophonIA/ELRC3.0 huggingface dataset:
English: You may have bleeding in your stomach.
Croatian: Možda imate krvarenje u trbušnoj šupljini.
English: Pre-filled syringe 2 years
Croatian: Napunjena štrcaljka 2 godine
English: Note for the pre-filled syringes fitted with an automatic safety system: The safety system is triggered at the end of the injection (see instructions in section 6.6).
Croatian: Napomena za napunjene štrcaljke opremljene automatskim sigurnosnim sustavom: Sigurnosni sustav aktivira se na kraju injekcije (vidjeti upute u dijelu 6.6).
English: As with other anticoagulants, bleeding may occur at any site.
Croatian: Kao i kod drugih antikoagulansa, krvarenje se može javiti na bilo kojem mjestu.
English: For patients have an operation called percutaneous coronary intervention (PCI):
Croatian: Za bolesnike koji idu na operaciju koja se zove perkutana koronarna intervencija (PCI):
English: Talk to your doctor or pharmacist before using Thorinane if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što primijenite Thorinane:
English: • If you are going to have an operation your first injection will be usually given 2 hours or 12 hours before your operation.
Croatian: • Ako idete na operaciju, prvu ćete dozu obično primiti 2 sata ili 12 sati prije operacije.
English: • Acute infective endocarditis
Croatian: • Akutni infektivni endokarditis
English: VTE = venous thromboembolic event (DVT and/or PE) *The 95% Confidence Intervals for the treatment differences for total VTE were:
Croatian: VTE = venski tromboembolijski događaj (DVT i/ili PE) *Intervali pouzdanosti od 95% za razlike između liječenja za ukupni VTE bili su:
English: • Rare: Alopecia*
Croatian: • Rijetko: alopecija*
English: It is important to achieve haemostasis at the puncture site after PCI.
Croatian: Važno je postići hemostazu na mjestu uboda nakon PCI-ja.
English: Instruct patients to report immediately if they experience any of the above signs or symptoms.
Croatian: Bolesnike treba uputiti da odmah prijave pojavu bilo kojeg od prethodno navedenih znakova ili simptoma.
English: • Lost of control over your bladder or bowel (so you cannot control when you go to the toilet).
Croatian: • gubitak kontrole nad mokraćnim mjehurom ili debelim crijevom (zbog čega ne možete kontrolirati kada ćete ići na toalet)
English: - Decide where you are going to inject the medicine.
Croatian: - Odlučite gdje ćete si injicirati lijek.
English: Do not use if the date has passed.
Croatian: Nemojte ga upotrijebiti ako je rok valjanosti istekao.
English: This amount is usually enough for a 4-hour session.
Croatian: Navedena je količina obično dovoljna za 4-satnu dijalizu.
English: Intra-patient and inter-patient variability is low.
Croatian: Intraindividualna i interindividualna varijabilnost je niska.
English: • Common: Allergic reaction
Croatian: • Često: alergijska reakcija
English: Throw away the cap.
Croatian: Pokrov bacite.
English: The efficacy data are provided in the table below.
Croatian: Podaci za djelotvornost navedeni su u sljedećoj tablici.
English: • Warfarin - used for thinning the blood
Croatian: • varfarin - koristi se za razrjeđivanje krvi
English: Retroperitoneal and intracranial haemorrhages were always considered major.
Croatian: Retroperitonejska i intrakranijalna krvarenja uvijek su se smatrala velikima.
English: A lounge chair, recliner, or bed propped up with pillows is ideal.
Croatian: Naslonjač, stolac s naslonom koji se podešava ili krevet s osloncem od jastuka su idealni.
English: Injection volume and dose concentration over the range 100-200 mg/mL does not affect pharmacokinetic parameters in healthy volunteers.
Croatian: Injekcijski volumen i koncentracija doze u rasponu od 100 do 200 mg/ml ne utječu na farmakokinetičke parametre u zdravih dobrovoljaca.
English: Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need.
Croatian: Enoksaparinnatrij se smije primjenjivati tijekom trudnoće samo ako liječnik utvrdi da postoji jasna potreba.
English: There were no differences in the rates of bleeding or other complications during the double-blind or follow-up periods.
Croatian: Nije bilo razlika u stopama krvarenja ili drugih komplikacija tijekom dvostruko slijepog razdoblja i tijekom razdoblja praćenja.
English: A total of 1,102 patients were enrolled in the study, and 1,073 patients were treated.
Croatian: U ispitivanje su bila uključena ukupno 1102 bolesnika, a liječeno je njih 1073.
English: Like other similar medicines (medicines to reduce blood clotting), Thorinane may cause bleeding which may potentially be life-threatening.
Croatian: Kao i drugi slični lijekovi (lijekovi koji smanjuju nastanak krvnih ugrušaka), Thorinane može uzrokovati krvarenje koje može biti opasno po život.
English: A total of 900 patients were randomized in the study and all patients were treated.
Croatian: U ispitivanju je randomizirano ukupno 900 bolesnika i svi su bili liječeni.
English: It is important for you to keep having Thorinane injections until your doctor decides to stop them.
Croatian: Važno je da nastavite primjenjivati injekcije lijeka Thorinane sve dok Vaš liječnik ne odluči da je vrijeme da prestanete.
English: This reduction in the combined incidence was maintained after 30 days (from 23.3 to 19.8%; relative risk reduction of 15%).
Croatian: To sniženje kombinirane incidencije bilo je održano nakon 30 dana (s 23,3 na 19,8%; smanjenje relativnog rizika: 15%).
English: • Skin irritation (local irritation).
Croatian: • nadraženost kože (lokalna iritacija)
English: 3) Choose an area on the right or left side of your stomach.
Croatian: 3) Odaberite mjesto na lijevoj ili desnoj strani trbuha.
English: If such use is considered absolutely necessary, the decision must be made only after a careful individual benefit risk assessment.
Croatian: Ako se takva primjena smatra apsolutno neophodnom, odluka se mora donijeti tek nakon pažljive ocjene koristi i rizika kod svakog pojedinog bolesnika.
English: Some of these cases were pregnant women in whom thrombosis led to maternal and foetal death.
Croatian: Neki od tih slučajeva zabilježeni su u trudnica u kojih je tromboza uzrokovala smrt majke i ploda.
English: In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy.
Croatian: Nema dokaza da enoksaparin prolazi kroz placentarnu barijeru u ljudi tijekom drugog i trećeg tromjesečja trudnoće.
English: • you have ever had a reaction to heparin that caused a severe drop in the number of your platelets
Croatian: • ako ste ikada imali reakciju na heparin koja je uzrokovala velik pad broja trombocita
English: • Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality)
Croatian: • Vrlo često: povišene vrijednosti jetrenih enzima (uglavnom transaminaze > 3 puta iznad gornje granice normale)
English: Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physician.
Croatian: Bolesnici moraju biti svjesni da se ti simptomi mogu pojaviti i da u tom slučaju o njima moraju obavijestiti svog liječnika obiteljske medicine.
English: This medicine should be injected just under the skin on your stomach, but not too near the belly button or any scar tissue (at least 5 cm away from these).
Croatian: Lijek treba injicirati neposredno ispod kože na trbuhu, ali ne previše blizu pupka ili ožiljnog tkiva (najmanje na 5 cm udaljenosti).
English: • If you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.
Croatian: • Ako imate bolan osip ili tamnocrvene točkice ispod kože koje ne nestaju kada ih pritisnete.
English: • Hyperkalaemia
Croatian: • Hiperkalijemija
English: Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11 1077XX Amsterdam Netherlands
Croatian: Strawinskylaan 1143, Toren C-11 1077XX Amsterdam Nizozemska
English: Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred.
Croatian: Obostrana venografija provedena je između 25. i 31. dana, ili ranije ako su se pojavili simptomi venske tromboembolije.
English: These included major haemorrhages, reported at most in 4.2 % of the patients (surgical patients).
Croatian: Uključivala su velika krvarenja, prijavljena u najviše 4,2% bolesnika (kirurških bolesnika).
English: Elderly patients (especially patients eighty years of age and older) may be at an increased risk for bleeding complications with the therapeutic dosage ranges.
Croatian: Stariji bolesnici (osobito oni u dobi od 80 ili više godina) mogu imati povećan rizik od komplikacija krvarenja kod primjene terapijskog raspona doza.
English: • Sudden severe headache.
Croatian: • iznenadna jaka glavobolja.
English: • Common: Urticaria, pruritus, erythema
Croatian: • Često: urtikarija, svrbež, eritem
English: Do not try to inject yourself if you have not been trained how to do so.
Croatian: Nemojte samoinjicirati (ubrizgavati sami sebi) lijek ako Vas nisu poučili kako.
English: This will send the medicine into the fatty tissue of the stomach.
Croatian: Tako će se lijek potisnuti u masno tkivo na trbuhu.
English: Plasma potassium should be monitored regularly especially in patients at risk.
Croatian: Treba redovito kontrolirati razinu kalija u plazmi, osobito u rizičnih bolesnika.
English: These agents include medicinal products such as:
Croatian: Među te se lijekove ubrajaju:
English: This difference persisted at three months [13.8% vs. 5.5% (n=23 vs 9), p=0.01].
Croatian: Ta je razlika bila prisutna i nakon tri mjeseca (13,8% naspram 5,5% [n=23 naspram 9], p=0,01).
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, tinzaparin ili dalteparin
English: In case of self-administration, patient should be advised to follow instructions provided in the patient information leaflet included in the pack of this medicine.
Croatian: U slučaju samoinjiciranja, bolesnika treba uputiti da slijedi upute navedene u uputi o lijeku, koja se nalazi u pakiranju ovog lijeka.
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).
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: This is because they are not exactly the same and do not have the same activity and instructions for use.
Croatian: Naime, ti lijekovi nisu potpuno isti, ne djeluju na isti način i imaju drugačije upute za uporabu.
English: If a child accidentally injects or swallows Thorinane, take them to a hospital causualty department straight away.
Croatian: Ako dijete slučajno injicira ili proguta Thorinane, odmah ga odvedite na bolnički odjel hitne pomoći.
English: These are more likely to appear in the area you have been injected with Thorinane.
Croatian: Njihova je pojava vjerojatnija na području gdje Vam je injiciran
English: Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required.
Croatian: Stoga se pažljivo moraju razmotriti i slijediti upute za primjenu specifične za svaki pojedini lijek.
English: This is because it needs to be given as an injection.
Croatian: To je zato što se lijek mora dati injekcijom.
English: • you have endocarditis (an infection of the inner lining of the heart)
Croatian: • ako imate endokarditis (infekciju unutarnje srčane ovojnice)
English: These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see section 4.4).
Croatian: Te su nuspojave dovele do različitih stupnjeva neuroloških oštećenja, uključujući dugotrajnu ili trajnu paralizu (vidjeti dio 4.4)
English: • you have high level of potassium in your blood (this may be checked with a blood test)
Croatian: • ako imate visoku razinu kalija u krvi (što se može provjeriti krvnom pretragom)
English: Also, tell your doctor if you have any problem with your spine or if you ever had spinal surgery.
Croatian: Isto tako, obavijestite svog liječnika ako imate bilo kakvih tegoba s kralježnicom ili ako ste nekada imali operaciju na kralježnici.
English: Use in children and adolescents The safety and efficacy of Thorinane has not been evaluated in children or adolescents.
Croatian: Primjena u djece i adolescenata Sigurnost i djelotvornost lijeka Thorinane nije se ispitivala u djece i adolescenata.
English: 8) Remove the needle by pulling it straight out.
Croatian: 8) Izvucite iglu povlačenjem ravno van.
English: These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dosage and clinical efficacy and safety.
Croatian: Ti se lijekovi razlikuju prema načinu proizvodnje, molekulskoj masi, specifičnoj anti-Xa i anti-IIa aktivnosti, jedinicama, dozama te kliničkoj djelotvornosti i sigurnosti.
English: However, even with high doses of protamine, the anti-Xa activity of enoxaparin sodium is never completely neutralized (maximum about 60%) (see the prescribing information for protamine salts).
Croatian: Međutim, čak i kada se primijene visoke doze protamina, anti-Xa aktivnost enoksaparinnatrija nikada se u potpunosti ne neutralizira (maksimalno 60%) (vidjeti informacije o lijeku za soli protamina).
English: Investigations • Rare: Hyperkalaemia* (see sections 4.4 and 4.5).
Croatian: Pretrage • Rijetko: hiperkalijemija* (vidjeti dijelove 4.4 i 4.5.)
English: Thorinane can be used to:
Croatian: Thorinane se može koristiti za:
English: Animal data have shown that enoxaparin passage through the placenta is minimal.
Croatian: Podaci iz ispitivanja na životinjama pokazali su da enoksaparin minimalno prolazi kroz placentu.
English: : Platelet increased >400 G/L
Croatian: : Povišena razina trombocita > 400 G/l
English: Steady-state is achieved on the second day of treatment.
Croatian: Stanje dinamičke ravnoteže postiže se drugog dana liječenja.
English: EXP The diluted solution must be used within 8 hours.
Croatian: EXP Razrijeđena otopina mora se upotrijebiti unutar 8 sati.
English: The recommended duration of treatment is 8 days or until hospital discharge, whichever comes first.
Croatian: Preporučeno trajanje liječenja je 8 dana ili do otpuštanja iz bolnice, što god nastupi prije.
English: • Pink patches on your skin.
Croatian: • ružičaste mrlje na koži.
English: This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions).
Croatian: To dovodi do razlika u farmakokinetici i povezanim biološkim aktivnostima (npr. antitrombinskoj aktivnosti i trombocitnim interakcijama).
English: Remember: Do not inject yourself within 5 cm of your belly button or around existing scars or bruises.
Croatian: Upamtite: Nemojte si lijek injicirati unutar 5 cm od pupka i oko postojećih ožiljaka ili modrica.
English: Thorinane is a biosimilar medicinal product.
Croatian: Thorinane je biosličan lijek.
English: • Arterial line injection:
Croatian: • Injekcija u arterijsku liniju:
English: Patients had to be treated in hospital for a minimum of 2 days and a maximum of 8 days, until clinical stabilization, revascularization procedures or hospital discharge.
Croatian: Bolesnici su se morali liječiti u bolnici tijekom najmanje 2 a najviše 8 dana, do kliničke stabilizacije, postupaka revaskularizacije ili otpusta iz bolnice.
English: Overall list of possible side effects: Very common (may affect more than 1 in 10 people)
Croatian: Cjelovit popis mogućih nuspojava: Vrlo česte (mogu se javiti u više od 1 na 10 osoba)
English: This should be at least 5 cm away from your belly button and out towards your sides.
Croatian: Mora biti najmanje 5 cm udaljeno od pupka i u smjeru boka.
English: STEMI type of heart attack if you are under 75 years old:
Croatian: STEMI vrsta srčanog udara, ako ste mlađi od 75 godina:
English: If you stop, you could get a blood clot which can be very dangerous.
Croatian: Ako prestanete, može nastati krvni ugrušak, što može biti vrlo opasno.
English: Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of enoxaparin sodium is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
Croatian: Postavljanje i uklanjanje epiduralnog katetera ili lumbalnu punkciju najbolje je provesti kada je antikoagulacijski učinak enoksaparinnatrija nizak; međutim, točno vrijeme do postizanja dovoljno niskog antikoagulacijskog učinka u svakog pojedinog bolesnika nije poznato.
English: Your doctor will be able to check this by carrying out a blood test.
Croatian: Vaš liječnik može to provjeriti krvnom pretragom.
English: 6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle).
Croatian: 6) Štrcaljku držite tako da igla bude usmjerena prema dolje (okomito pod kutom od 90°).
English: Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.
Croatian: Razine aktivnosti anti-Xa i dalje su mjerljive u tim vremenskim točkama, pa navedeni vremenski razmaci nisu jamstvo da će se izbjeći neuraksijalni hematom.
English: Enoxaparin sodium regimen administered during these clinical trials varies depending on indications.
Croatian: Režim liječenja enoksaparinnatrijem koji se primjenjivao u tim kliničkim ispitivanjima razlikovao se ovisno o indikacijama.
English: • Rare: Cutaneous vasculitis*, skin necrosis* usually occurring at the injection site (these phenomena have been usually preceded by purpura or erythematous plaques, infiltrated and painful).
Croatian: • Rijetko: kožni vaskulitis*, nekroza kože* koja se obično razvija na mjestu injiciranja (tim fenomenima obično prethode purpura ili eritemski plakovi, infiltrirani i bolni).
English: Thorinane can be used during breastfeeding.
Croatian: Thorinane se može primjenjivati tijekom dojenja.
English: CARTON (Packs of 2 or 10)
Croatian: KUTIJA (Pakiranje od 2 ili 10)
English: If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate.
Croatian: Ako je ova kombinacija indicirana, enoksaparinnatrij treba primjenjivati uz pažljivo kliničko i laboratorijsko praćenje kada je to prikladno.
English: When the container is full, give it to your doctor or home care nurse for disposal.
Croatian: Kada se spremnik napuni predajte ga svom liječniku ili patronažnoj sestri radi zbrinjavanja.
English: • Your doctor will decide how long you should receive Thorinane.
Croatian: • Vaš će liječnik odrediti koliko dugo trebate primati Thorinane.
English: How much will be given to you
Croatian: Koliko lijeka ćete primiti
English: Depending on when you were last given Thorinane, your doctor may decide to give an additional dose of Thorinane before a PCI operation.
Croatian: • Ovisno o tome kad ste zadnji put primili Thorinane, Vaš će liječnik možda odlučiti primijeniti dodatnu dozu lijeka Thorinane prije perkutane koronarne intervencije.
English: Likewise, consider not using enoxaparin sodium until at least 4 hours after the spinal/epidural puncture or after the catheter has been removed.
Croatian: Isto tako, razmislite o tome da ne primijenite enoksaparinnatrij najmanje 4 sata nakon spinalne/epiduralne punkcije ili uklanjanja katetera.
English: The safety and efficacy of prophylactic doses in obese patients (BMI >30 kg/m2) has not been fully determined and there is no consensus for dose adjustment.
Croatian: Sigurnost i djelotvornost profilaktičkih doza kod pretilih bolesnika (ITM > 30 kg/m2) nisu u potpunosti ustanovljene i ne postoji konsenzus o prilagodbi doze.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili biste mogli uzeti bilo koje druge lijekove.
English: There were no significant differences in major haemorrhages, although a haemorrhage at the site of the SC injection was more frequent.
Croatian: Nije bilo značajnih razlika u velikim krvarenjima, iako je krvarenje na mjestu s.c. injiciranja bilo češće.
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 thrombocytopenia - within 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: 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 Thorinane.
Croatian: Ako trebate ići na spinalnu punkciju ili operaciju kod koje se koristi epiduralna ili spinalna anestezija, recite svom liječniku da primjenjujete Thorinane.
English: Other adverse reactions observed in clinical studies and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below.
Croatian: Ostale nuspojave primijećene u kliničkim ispitivanjima i prijavljene nakon stavljanja lijeka u promet (* označava nuspojave prijavljene nakon stavljanja lijeka u promet) navedene su u nastavku.
English: Change the place where you inject between the left and right sides of your stomach, depending on the area you were last injected.
Croatian: Mijenjajte mjesto injekcije između lijeve i desne strane trbuha, ovisno o mjestu zadnje injekcije.
English: How to give yourself an injection of Thorinane
Croatian: Kako sam sebi dati injekciju Thorinanea
English: The beneficial effect of enoxaparin sodium on the primary end point observed during the first 30 days was maintained over a 12 month follow-up period.
Croatian: Povoljan učinak enoksaparinnatrija na primarnu mjeru ishoda primijećen tijekom prvih 30 dana održao se tijekom 12-mjesečnog razdoblja praćenja.
English: Once you have removed the cap, do not allow the needle to touch anything.
Croatian: Nakon što ste s igle skinuli pokrov pazite da njome ništa ne dotaknete.
English: Do not use this medicine if you notice any visible change in the appearance of the solution.
Croatian: - Ovaj lijek nemojte primijeniti ako primijetite bilo kakvu vidljivu promjenu u izgledu lijeka.
English: Stop using Thorinane 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 Thorinane i odmah se obratite liječniku ili medicinskoj sestri ako primijetite bilo koji znak teške alergijske reakcije (kao što su otežano disanje, oticanje usana, usta, grla ili očiju).
English: The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding.
Croatian: Režim doziranja treba odabrati liječnik na temelju individualne ocjene koja uključuje procjenu tromboembolijskog rizika i rizika od krvarenja.
English: The recommended dosage adjustments do not apply to the haemodialysis indication.
Croatian: Preporučene prilagodbe doze ne odnose se na primjenu kod hemodijalize.
English: Musculoskeletal, connective tissue and bone disorders • Rare: Osteoporosis* following long term therapy (greater than 3 months)
Croatian: Poremećaji mišićno-koštanog sustava, vezivnog tkiva i kostiju • Rijetko: osteoporoza* nakon dugotrajne terapije (dulje od 3 mjeseca)
English: STEMI type of heart attack if you are 75 years old or older:
Croatian: STEMI vrsta srčanog udara, ako imate 75 ili više godina: