FrancophonIA/ELRC3.0 huggingface dataset:
English: These agents include medicinal products such as:
Slovenian: Med takšna zdravila spadajo na primer:
English: If such use is considered absolutely necessary, the decision must be made only after a careful individual benefit risk assessment.
Slovenian: Če je takšna uporaba popolnoma nujna, se je zanjo treba odločiti le po skrbni individualni oceni koristi in tveganja.
English: Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required.
Slovenian: Zato sta potrebni posebna pozornost in upoštevanje navodil za uporabo, specifičnih za vsako lastniško zdravilo.
English: The efficacy data are provided in the table below.
Slovenian: Podatki o učinkovitosti so prikazani v spodnji preglednici.
English: Concomitant use not recommended:
Slovenian: Sočasna uporaba ni priporočljiva:
English: Prophylaxis should be continued until the patient no longer has significantly reduced mobility.
Slovenian: S profilakso je treba nadaljevati, dokler bolnikova mobilnost ni več bistveno zmanjšana.
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).
Slovenian: • Ko boste odšli domov, boste morda morali še naprej uporabljati zdravilo Thorinane in si ga boste morali dajati sami (glejte spodnja navodila, kako to naredite).
English: Instruct patients to report immediately if they experience any of the above signs or symptoms.
Slovenian: Bolnikom naročite, da morajo nemudoma povedati, če občutijo katerega od omenjenih znakov ali simptomov.
English: The patients had to be followed up to 30 days.
Slovenian: Bolnike so morali spremljati do 30 dni.
English: The usual duration of treatment is 2 to 8 days.
Slovenian: Običajno traja zdravljenje od 2 do 8 dni.
English: Your doctor may decide to keep you under closer observation or change your medicine.
Slovenian: Zdravnik se lahko odloči, da vas bo natančno nadzoroval, ali da vam bo spremenil zdravilo.
English: This could be a sign of bleeding in the brain.
Slovenian: To je lahko znak krvavitve v možganih.
English: Circulating antibodies may persist several years.
Slovenian: Protitelesa v obtoku lahko ostanejo prisotna več let.
English: Do not give yourself a double dose on the same day to make up for a forgotten dose.
Slovenian: Ne dajte si na en dan dvojnega odmerka, da bi nadomestili pozabljenega.
English: The amount of Thorinane given to you will depend on your age and the kind of heart attack you have had.
Slovenian: Količina zdravila Thorinane, ki jo boste dobili, bo odvisna od vaše starosti in od vrste srčnega infarkta, ki ste jo imeli.
English: Operations and anesthetics
Slovenian: Operacije in anestezija
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.
Slovenian: • Če imate boleč izpuščaj s temno rdečimi podkožnimi pegami, ki ne izginejo, če nanje pritisnete.
English: 8) Remove the needle by pulling it straight out.
Slovenian: 8) Odstranite iglo tako, da jo izvlečete naravnost ven.
English: • Severe allergic reaction.
Slovenian: • Huda alergijska reakcija.
English: • Traceability
Slovenian: • Sledljivost
English: How much will be given to you
Slovenian: Koliko zdravila boste dobili
English: Treatment should be maintained for a minimum of 2 days and continued until clinical stabilization.
Slovenian: Zdravljenje mora trajati vsaj 2 dni, nadaljevati ga je treba do klinične stabilizacije.
English: There is no information available concerning the first trimester.
Slovenian: O prehajanju v prvem trimesečju ni podatkov.
English: • If you are going to have an operation your first injection will be usually given 2 hours or 12 hours before your operation.
Slovenian: • Če imate predvideno operacijo, boste prvo injekcijo po navadi dobili 2 uri ali 12 ur pred operacijo.
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki ali škatli.
English: - Decide where you are going to inject the medicine.
Slovenian: - Odločite se, kam boste injicirali zdravilo.
English: Some of these cases were pregnant women in whom thrombosis led to maternal and foetal death.
Slovenian: V nekaterih takšnih primerih je šlo za nosečnice, pri katerih je tromboza povzročila smrt matere in ploda.
English: This amount is usually enough for a 4-hour session.
Slovenian: Ta količina po navadi zadošča za 4-urno dializo.
English: • Common: Allergic reaction
Slovenian: • Pogosti: Alergijska reakcija
English: CHINA
Slovenian: KITAJSKA
English: These patients should be observed carefully for signs and symptoms of thromboembolism.
Slovenian: Te bolnike je treba natančno opazovati glede znakov in simptomov trombembolij.
English: • Acute infective endocarditis
Slovenian: • Akutni infekcijski endokarditis
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.
Slovenian: Ne pozabite, da v nekaterih primerih zaradi graduacije na brizgi ni mogoče nastaviti točnega odmerka; v takšnem primeru je treba količino zaokrožiti na najbližjo graduacijo.
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).
Slovenian: Opomba za napolnjene injekcijske brizge, opremljene z avtomatskim varnostnim sistemom: Varnostni sistem se sproži na koncu injiciranja (glejte navodila v poglavju 6.6).
English: • you have had an operation recently on your eyes or brain • you are elderly (over 65 years old) and especially if you are over 75 years old
Slovenian: • če ste pred kratkim imeli operacijo oči ali možganov • če ste starejša oseba (ste starejši od 65 let), še zlasti, če ste starejši od 75 let
English: Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physician.
Slovenian: Bolniki se morajo zavedati, da se lahko pojavijo takšni simptomi, in vedeti, da morajo v takšnem primeru obvestiti svojega splošnega zdravnika.
English: The amount will depend on the reason it is being used.
Slovenian: Količina bo odvisna od razloga, zaradi katerega dobivate zdravilo.
English: This reduction in the combined incidence was maintained after 30 days (from 23.3 to 19.8%; relative risk reduction of 15%).
Slovenian: To zmanjšanje skupne incidence se je ohranilo po 30 dneh (s 23,3 na 19,8 %, relativno zmanjšanje tveganja 15 %).
English: If you are able to give this medicine to yourself, your doctor or nurse will show you how to do this.
Slovenian: Če si lahko zdravilo injicirate sami, vam bosta zdravnik ali medicinska sestra pokazala, kako to opraviti.
English: • A feeling of tenderness and swelling in your stomach.
Slovenian: • Občutek občutljivosti in oteklosti v trebuhu.
English: This is more likely to happen in people with kidney problems or diabetes.
Slovenian: To je verjetneje pri osebah, ki imajo težave z ledvicami ali sladkorno bolezen.
English: Different doses and formulations and dosing regimens can be used.
Slovenian: Uporabiti je mogoče različne odmerke in oblike ter odmerne sheme.
English: All patients were also treated with acetylsalicylic acid for a minimum of 30 days.
Slovenian: Vsi bolniki so poleg tega vsaj 30 dni dobivali tudi acetilsalicilno kislino.
English: These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see section 4.4).
Slovenian: Te reakcije so povzročile različno stopnjo nevroloških okvar, vključno z dolgotrajno ali trajno paralizo (glejte poglavje 4.4).
English: • you have high level of potassium in your blood (this may be checked with a blood test)
Slovenian: • če imate v krvi visoko koncentracijo kalija (to je mogoče preveriti s preiskavo krvi)
English: • Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality)
Slovenian: • Zelo pogosti: Zvišanje jetrnih encimov (v glavnem transaminaz na > 3-kratno zgornjo mejo normalnih vrednosti)
English: Steady-state is achieved on the second day of treatment.
Slovenian: Stanje dinamičnega ravnovesja je doseženo drugi dan zdravljenja.
English: The benefit is not established for a treatment longer than 14 days.
Slovenian: Korist zdravljenja, daljšega od 14 dni, ni ugotovljena.
English: • If you have problems with your kidneys you may be given a smaller amount of Thorinane.
Slovenian: • Če imate težave z ledvicami, boste lahko dobili manjšo količino zdravila Thorinane.
English: • Rare: Alopecia*
Slovenian: • Redki: Alopecija*
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.
Slovenian: Ledvični očistek aktivnih fragmentov predstavlja okrog 10 % uporabljenega odmerka, celotno ledvično izločanje aktivnih in neaktivnih fragmentov pa 40 % odmerka.
English: Keeping a diary will help to make sure you do not miss a dose.
Slovenian: Vodenje dnevnika vam bo pomagalo, da ne boste izpustili nobenega odmerka.
English: Once you have removed the cap, do not allow the needle to touch anything.
Slovenian: Po odstranitvi pokrovčka pazite, da se igla ne dotakne ničesar.
English: A total of 900 patients were randomized in the study and all patients were treated.
Slovenian: Skupno je bilo v študiji randomiziranih 900 bolnikov in vsi so bili zdravljeni.
English: Use in children and adolescents The safety and efficacy of Thorinane has not been evaluated in children or adolescents.
Slovenian: Uporaba pri otrocih in mladostnikih Varnost in učinkovitost zdravila Thorinane pri otrocih in mladostnikih nista bili ocenjeni.
English: It is not known whether unchanged enoxaparin is excreted in human breast milk.
Slovenian: Ni znano, ali se nespremenjeni enoksaparin pri človeku izloča v materinem mleku.
English: Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11 1077XX Amsterdam Netherlands
Slovenian: Strawinskylaan 1143, Toren C-11 1077XX Amsterdam Nizozemska
English: Intra-patient and inter-patient variability is low.
Slovenian: Intraindividualna in interindividualna variabilnost sta majhni.
English: - Make sure you know how much you are going to inject.
Slovenian: - Prepričajte se, da veste, koliko zdravila si morate injicirati.
English: Treatment in patients with acute STEMI
Slovenian: Zdravljenje bolnikov z akutnim STEMI
English: As with other anticoagulants, bleeding may occur at any site.
Slovenian: Tako kot pri drugih antikoagulansih se lahko kjer koli v telesu pojavi krvavitev.
English: 4,716 patients underwent percutaneous coronary intervention receiving antithrombotic support with blinded study drug.
Slovenian: 4.716 bolnikom so naredili perkutano koronarno intervencijo in dobili so antitrombotično podporo s slepljenim raziskovanim zdravilom.
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.
Slovenian: Ugodni učinek natrijevega enoksaparinata na primarni opazovani dogodek, ugotovljen v prvih 30 dneh, se je ohranil med 12-mesečnim obdobjem spremljanja.
English: SC, IV and extracorporeal use
Slovenian: SC, IV in izventelesna uporaba
English: LMWHs are biological medicinal products.
Slovenian: NMH so biološka zdravila.
English: Shenzhen Techdow Pharmaceutical Co., Ltd No.19, Gaoxinzhongyi Road, Hi-tech Industrial Park Nanshan District
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin) Shenzhen Techdow Pharmaceutical Co., Ltd No.19, Gaoxinzhongyi Road, Hi-tech Industrial Park Nanshan District
English: If you think that you have used too much or too little Thorinane, tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem.
Slovenian: Če menite, da ste uporabili preveč ali premalo zdravila Thorinane, nemudoma obvestite svojega zdravnika, medicinsko sestro ali farmacevta, tudi če nimate nobenih težav.
English: This difference persisted at three months [13.8% vs. 5.5% (n=23 vs 9), p=0.01].
Slovenian: Ta razlika se je ohranila tudi po treh mesecih [13,8 % v primerjavi s 5,5 % (n = 23 v primerjavi z 9), p = 0,01].
English: • The maximum amount of Thorinane given for the first two injections is 7,500 IU (75 mg).
Slovenian: • Največji odmerek zdravila Thorinane, uporabljen v prvih dveh injekcijah, je 7.500 i.e. (75 mg).
English: It is recommended to prepare the dilution immediately before use.
Slovenian: Raztopino je priporočljivo pripraviti tik pred uporabo.
English: These included major haemorrhages, reported at most in 4.2 % of the patients (surgical patients).
Slovenian: Vključno s hudimi krvavitvami, opisanimi pri največ 4,2 % bolnikov (kirurški bolniki).
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.
Slovenian: Ta zdravila se med seboj razlikujejo po postopku izdelave, molekulski masi, specifični aktivnosti anti-Xa in anti-IIa, enotah, odmerjanju ter klinični učinkovitosti in varnosti.
English: Date of first authorisation: 15/09/2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15/09/2016
English: It is important for you to keep having Thorinane injections until your doctor decides to stop them.
Slovenian: Pomembno je, da injekcije zdravila Thorinane uporabljate, dokler vam zdravnik ne naroči, da prenehajte.
English: Thorinane is indicated in adults for:
Slovenian: Zdravilo Thorinane je indicirano pri odraslih za:
English: If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots.
Slovenian: Če ste noseči in imate mehansko srčno zaklopko, imate lahko večje tveganje za nastanek krvnih strdkov.
English: This will send the medicine into the fatty tissue of the stomach.
Slovenian: S tem boste vbrizgali zdravilo v maščobno tkivo trebuha.
English: The recommended duration of treatment is 8 days or until hospital discharge, whichever comes first.
Slovenian: Priporočeno trajanje zdravljenja je 8 dni ali do odpusta iz bolnišnice, kar od tega je prej.
English: • Sudden severe headache.
Slovenian: • Nenaden hud glavobol.
English: The recommended dosage adjustments do not apply to the haemodialysis indication.
Slovenian: Priporočene prilagoditve odmerjanja ne veljajo, če je indikacija hemodializa.
English: No major bleeding occurred.
Slovenian: Ugotovili niso tudi nobene večje krvavitve.
English: Retroperitoneal and intracranial haemorrhages were always considered major.
Slovenian: Retroperitonealne in intrakranialne krvavitve so bile vedno ocenjene kot hude.
English: • If you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
Slovenian: • Če ste alergični na heparin ali druge nizkomolekularne heparine, npr. na nadroparin, tinzaparin ali dalteparin.
English: Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need.
Slovenian: Natrijev enoksaparinat naj bi med nosečnostjo uporabljali le, če zdravnik ugotovi, da je to res potrebno.
English: Renal impairment (see sections 4.4 and 5.2)
Slovenian: Okvara ledvic (glejte poglavji 4.4 in 5.2)
English: Water for injections.
Slovenian: Voda za injekcije.
English: Treatment of DVT and PE
Slovenian: Zdravljenje GVT in PE
English: They resolve after a few days and should not cause treatment discontinuation.
Slovenian: Ti po nekaj dnevih izginejo in zdravljenja zaradi njih bi smeli prekiniti.
English: At higher doses, increases in activated partial thromboplastin time (aPTT), and activated clotting time (ACT) may occur.
Slovenian: Med uporabo večjih odmerkov se lahko pojavi podaljšanje aktiviranega parcialnega tromboplastinskega časa (aPTČ) in aktiviranega časa strjevanja (ACT - activated clotting time).
English: Injection volume and dose concentration over the range 100-200 mg/mL does not affect pharmacokinetic parameters in healthy volunteers.
Slovenian: Injicirana količina in koncentracija odmerka v razponu od 100 do 200 mg/ml pri zdravih prostovoljcih ne vplivata na farmakokinetične parametre.
English: • Warfarin - used for thinning the blood
Slovenian: • Varfarin - uporablja se za redčenje krvi.
English: If not, use another syringe.
Slovenian: V nasprotnem primeru uporabite drugo injekcijsko brizgo.
English: Animal data have shown that enoxaparin passage through the placenta is minimal.
Slovenian: Podatki pri živalih so pokazali, da je prehajanje enoksaparina skozi placento minimalno.
English: Do not inject Thorinane into a muscle.
Slovenian: Zdravila Thorinane ne injicirajte v mišico.
English: Your doctor will be able to check this by carrying out a blood test.
Slovenian: Zdravnik lahko to preveri s preiskavo krvi.
English: Investigations • Rare: Hyperkalaemia* (see sections 4.4 and 4.5).
Slovenian: Preiskave • Redki: Hiperkaliemija* (glejte poglavji 4.4 in 4.5)
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.
Slovenian: Varnost in učinkovitost profilaktičnih odmerkov pri debelih bolnikih (ITM > 30 kg/m2) nista povsem ugotovljeni in soglasja glede prilagoditve odmerkov ni.
English: Musculoskeletal, connective tissue and bone disorders • Rare: Osteoporosis* following long term therapy (greater than 3 months)
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva • Redki: Osteoporoza* po dolgotrajnem zdravljenju (več kot 3 mesece)
English: Overall list of possible side effects: Very common (may affect more than 1 in 10 people)
Slovenian: Celotni seznam možnih neželenih učinkov: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: • Arterial line injection:
Slovenian: • Injiciranje v arterijsko linijo:
English: • Common: Urticaria, pruritus, erythema
Slovenian: • Pogosti: Urtikarija, srbenje, eritem
English: The anticoagulant effects can be largely neutralized by the slow IV injection of protamine.
Slovenian: Antikoagulantni učinek je mogoče v veliki meri nevtralizirati s počasnim intravenskim injiciranjem protamina.
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.
Slovenian: V primeru samoinjiciranja je treba bolniku naročiti, naj upošteva navodila v navodilu za uporabo, priloženem v pakiranju zdravila.
English: • Moderate and mild renal impairment
Slovenian: • Zmerna in blaga okvara ledvic
English: Like other similar medicines (medicines to reduce blood clotting), Thorinane may cause bleeding which may potentially be life-threatening.
Slovenian: Tako kot druga podobna zdravila (zdravila proti strjevanju krvi) lahko tudi zdravilo Thorinane povzroči krvavitve, ki so lahko celo smrtno nevarne.
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.
Slovenian: • Mravljinčenje, omrtvičenost in mišična šibkost (predvsem v spodnjem delu telesa), če ste imeli spinalno punkcijo ali spinalno anestezijo.
English: The skin fold should not be released until the injection is complete.
Slovenian: Kožne gube ne smete izpustiti, dokler injiciranje ni končano.
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.
Slovenian: Če imate predvideno spinalno punkcijo ali operacijo, pri kateri se uporablja spinalna ali epiduralna anestezija, morate zdravniku povedati, da uporabljate zdravilo Thorinane.
English: • You notice yellowing of your skin or eyes and your urine becomes darker in colour.
Slovenian: • Če opazite porumenelost kože ali očesnih beločnic ali če urin postane temnejše barve.
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.
Slovenian: Namestitev ali odstranitev epiduralnega katetra oz. lumbalno punkcijo je najbolje izvesti, ko je antikoagulantni učinek natrijevega enoksaparinata majhen, toda natančen čas, ko je dosežen dovolj majhen antikoagulantni učinek pri posameznem bolniku, ni znan.
English: It should not be mixed or co-administered with other medications.
Slovenian: Ne smete ga mešati ali uporabiti sočasno z drugimi zdravili.
English: If bleeding occurs, the origin of the haemorrhage should be investigated and appropriate treatment instituted.
Slovenian: Če se pojavi krvavitev, je treba ugotoviti njen vir in uvesti ustrezno zdravljenje.
English: Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials.
Slovenian: Natrijev enoksaparinat so ocenili pri več kot 15.000 bolnikih, ki so ga prejemali v kliničnih preskušanjih.
English: This decrease was mainly attributed to a decrease in ATIII level secondary to a reduced synthesis of ATIII in patients with hepatic impairment.
Slovenian: To zmanjšanje so pripisali predvsem zmanjšanju ravni ATIII zaradi zmanjšane sinteze ATIII pri bolnikih z okvaro jeter.
English: • are currently using medicines which affect bleeding (see section below - Other medicines).
Slovenian: • če trenutno uporabljate zdravila, ki vplivajo na strjevanje krvi (glejte spodaj - poglavje Druga
English: Also, tell your doctor if you have any problem with your spine or if you ever had spinal surgery.
Slovenian: Prav tako morate zdravniku povedati, če imate kakšne težave s hrbtenico, ali če ste kdaj imeli operacijo na hrbtenici.
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.
Slovenian: Če se vam pojavi krvavitev, ki se ne ustavi sama od sebe, ali če se vam pojavijo znaki prekomerne krvavitve (izredna šibkost, utrujenost, bledica, omotica, glavobol ali nepojasnjeno otekanje), se takoj posvetujte z zdravnikom.
English: These anticoagulant activities are mediated through anti-thrombin III (ATIII) resulting in anti-thrombotic activities in humans.
Slovenian: Te antikoagulantne učinke posreduje antitrombin III (ATIII); posledica je antitrombotično delovanje pri človeku.
English: Start taking the direct oral anticoagulant 0-2 hours before the time you would have had the next injection, then continue as normal.
Slovenian: Neposredni peroralni antikoagulans začnite jemati 0 do 2 uri pred časom, ko bi bila na vrsti naslednja injekcija, nato nadaljujte kot običajno.
English: • you have ever had a reaction to heparin that caused a severe drop in the number of your platelets
Slovenian: • če ste kdaj imeli reakcijo na heparin, ki vam je povzročila hudo zmanjšanje števila trombocitov
English: Enoxaparin sodium treatment is prescribed for an average period of 10 days.
Slovenian: Zdravljenje z natrijevim enoksaparinatom se predpiše za povprečno 10 dni.
English: In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy.
Slovenian: Pri človeku ni dokazov, da bi enoksaparin v drugem in tretjem trimesečju nosečnosti prehajal skozi placentno pregrado.
English: Before injecting yourself with Thorinane - Check the expiry date on the medicine.
Slovenian: Preden si injicirate zdravilo Thorinane - Preverite datum izteka roka uporabnosti na ovojnini.
English: Pre-filled syringe 2 years
Slovenian: Napolnjena injekcijska brizga 2 leti