FrancophonIA/ELRC3.0 huggingface dataset:
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Slovenian: Humani polispecifični imunoglobulin večinoma vsebuje imunoglobulin G (IgG) s širokim spektrom protiteles proti povzročiteljem nalezljivih bolezni.
English: Your doctor will determine the appropriate infusion technique and the infusion rate for you taking into account your individual dose, dosing frequency and product tolerability.
Slovenian: Zdravnik bo določil za vas najprimernejšo tehniko in hitrost infundiranja, pri čemer bo upošteval vaš individualni odmerek, pogostnost odmerjanja in prenosljivost zdravila
English: Patients should be informed about first symptoms of thromboembolic events including shortness of breath, pain and swelling of a limb, focal neurological deficits and chest pain and should be advised to contact their physician immediately upon onset of symptoms.
Slovenian: Bolnike je treba obvestiti o prvih simptomih trombemboličnih dogodkov, vključno s kratko sapo, bolečimi in oteklimi okončinami, fokalnimi nevrološkimi primanjkljaji in bolečinami v prsnem košu, in jim svetovati, da se po pojavu teh simptomov takoj posvetujejo z zdravnikom.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Slovenian: Kadar se zdravila izdelujejo iz humane krvi ali plazme, je treba uvesti nekatere ukrepe za preprečevanje okužb oziroma njihovega prenosa na bolnike.
English: 5 Preparation of Hizentra for infusion
Slovenian: 5 Priprava zdravila Hizentra za infundiranje
English: For safety with respect to transmissible agents, see section 4.4.
Slovenian: Za zaščito pred prenosljivimi povzročitelji glejte poglavje 4.4.
English: • In the case, you will use the manual push infusion technique with a syringe, you may use only one infusion site per syringe.
Slovenian: • V primeru, da boste uporabljali tehniko infundiranja z ročnim potiskanjem z injekcijsko brizgo, smete uporabiti samo eno mesto infundiranja na eno injekcijsko brizgo.
English: Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Slovenian: Humani polispecifični imunoglobulin vsebuje protitelesa IgG, prisotna pri normalni populaciji.
English: To assess the safety and tolerability of higher infusion rates applied via the manual push and pumpassisted administration, 49 PID subjects aged 2 to 75 years were enrolled in an open-label, multicentre, parallel-arm, nonrandomised phase IV HILO (Hizentra Label Optimization) study and treated with Hizentra for at least 12 weeks (11 paediatric patients aged 2 to <18, 35 adult patients aged 18 to 65, and 3 geriatric patients aged >65 years).
Slovenian: Za oceno varnosti in prenosljivosti višjih hitrosti infundiranja, apliciranih z ročnim potiskanjem in s pomočjo infuzijske črpalke, so v odprto, multicentrično, nerandomizirano študijo vzporednih skupin IV. faze HILO (Hizentra Label Optimization) vključili 49 preiskovancev s PID, starih od 2 do 75 let, in jih zdravili z zdravilom Hizentra najmanj 12 tednov (11 pediatričnih bolnikov, starih od 2 do < 18 let, 35 odraslih bolnikov, starih od 18 do 65 let, in 3 geriatrične bolnike, stare > 65 let).
English: A loading dose of at least 0.2 to 0.5 g/kg (1.0 to 2.5 ml/kg) body weight may be required.
Slovenian: Začetni odmerek bo verjetno vsaj 0,2 do 0,5 g/kg (1,0 do 2,5 ml/kg) telesne mase.
English: Your doctor will determine your weekly Hizentra dose.
Slovenian: Zdravnik bo določil, kakšen bo vaš tedenski odmerek zdravila Hizentra.
English: Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec CSL Behring GmbH
English: Paediatric population The same interactions may occur in the paediatric population.
Slovenian: Pediatrična populacija Enaka medsebojna delovanja se lahko pojavijo pri pediatrični populaciji.
English: If the Hizentra pre-filled syringe size does not match the pump requirements, then the contents of the pre-filled syringe can be transferred to another syringe of a size specific for the pump.
Slovenian: Če velikost napolnjene injekcijske brizge zdravila Hizentra ne ustreza zahtevam črpalke, lahko vsebino napolnjene injekcijske brizge prenesete v drugo brizgo takšne velikosti, ki je specifična za črpalko.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped viruses HAV and parvovirus B19.
Slovenian: Uvedeni ukrepi so učinkoviti za viruse z ovojnico, kot so HIV, HBV in HCV, ter za viruse brez ovojnice, HAV in parvovirus B19V.
English: Side effects such as these may occur even when you have previously received human immunoglobulins and tolerated them well.
Slovenian: Podobni neželeni učinki se lahko pojavijo celo, če ste že prejemali humane imunoglobuline in jih dobro prenašali.
English: OUTER BOX (vial)
Slovenian: ŠKATLA (viala)
English: Please note that alcohol swabs, needles and other supplies or equipment are not contained in the pack.
Slovenian: Prosimo upoštevajte, da alkoholni zloženci, igle in druga oprema ali pripomočki niso priloženi pakiranju zdravila.
English: Caution should be exercised in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilization, severely hypovolemic patients, patients with diseases which increase blood viscosity).
Slovenian: Pri bolnikih z obstoječimi dejavniki tveganja za trombotične dogodke (kot je starost, hipertenzija, sladkorna bolezen in žilna bolezen ali trombotične epizode, bolniki s pridobljenimi ali podedovanimi trombofilnimi stanji, dalj časa nepokretni bolniki, hudo hipovolemični bolniki, bolniki z boleznimi, ki zvišujejo viskoznost krvi), je potrebna previdnost).
English: • Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in nalepki na viali poleg oznake EXP.
English: Efficacy of Hizentra has been demonstrated over placebo after switching from intravenous immunoglobulins (IVIG).
Slovenian: Učinkovitost zdravila Hizentra so dokazali v primerjavi s placebom po prehodu z intravenskih imunoglobulinov (i.v.Ig).
English: Alcohol swabs, needles and other supplies or equipment are not contained in the pack.
Slovenian: Alkoholni zloženci, igle in druga oprema ali pripomočki niso priloženi pakiranju zdravila.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (liver inflammation), and for the non-enveloped hepatitis A virus and parvovirus B19.
Slovenian: Ukrepi so učinkoviti proti virusom z ovojnico, kot so virus humane imunske pomanjkljivosti (HIV, virus, ki povzroča AIDS), virusa hepatitisa B in C (vnetje jeter) ter proti virusom brez ovojnice, kot sta virus hepatitisa A in parvovirus B19.
English: Sustained IgG trough levels with a mean concentration of 12.53 g/l were thereby achieved throughout the treatment period.
Slovenian: Vzdrževane najnižje ravni IgG s srednjo koncentracijo 12,53 g/l so bile tako dosežene skozi celotno obdobje zdravljenja.
English: The primary efficacy endpoint was the percentage of subjects who had a CIDP relapse (defined as a ≥ 1 point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline) or were withdrawn for any other reason in the Hizentra treatment period.
Slovenian: Primarni opazovani dogodek učinkovitosti je bil delež preiskovancev s ponovitvijo (relapsom) CIDP (opredeljeno kot povečanje za ≥ 1 točko na prilagojeni lestvici INCAT ([Inflammatory Neuropathy Cause and Treatment - vzrok in zdravljenje vnetne nevropatije] glede na izhodišče) ali preiskovancev, ki so izstopili iz študije iz kateregakoli drugega razloga v času zdravljenja z zdravilom Hizentra.
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration, ATC code: J06BA01.
Slovenian: Farmakoterapevtska skupina: imunoglobulini humanega izvora: polispecifični humani imunoglobulini za ekstravaskularno uporabo, oznaka ATC: J06BA01.
English: The extension study investigated the long-term safety and efficacy of Hizentra maintenance therapy in the two weekly doses, 0.2 g/kg and 0.4 g/kg bw.
Slovenian: V podaljšani študiji so preučevali dolgoročno varnost in učinkovitost vzdrževalnega zdravljenja z zdravilom Hizentra pri dveh tedenskih odmerkih, 0,2 g/kg in 0,4 g/kg telesne mase.
English: Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be switched to Hizentra only under close medical supervision.
Slovenian: Bolniki, ki imajo protitelesa proti IgA, pri katerih je zdravljenje s subkutanimi zdravili IgG edina možnost, je treba prehod na zdravljenje z izdelkom Hizentra strogo nadzorovati.
English: There were no differences in the pharmacokinetics, safety and efficacy profiles as compared with adult subjects.
Slovenian: Razlik v farmakokinetičnih parametrih ter profilu varnosti in učinkovitosti v primerjavi z odraslimi bolniki niso ugotovili.
English: Paediatric population The same warnings and precautions apply to the paediatric population.
Slovenian: Pediatrična populacija Enaka opozorila in previdnostni ukrepi veljajo za pediatrično populacijo.
English: The weekly maintenance doses may be divided into smaller doses and administered as often as required during the week.
Slovenian: Tedenski vzdrževalni odmerki se lahko razdelijo na manjše odmerke in se lahko dajejo tekom tedna tako pogosto, kot je potrebno.
English: Elderly population The same warnings and precautions apply to the elderly population.
Slovenian: Starejša populacija Enaka opozorila in previdnostni ukrepi veljajo za starejšo populacijo.
English: Tell your doctor if you have a history of heart or blood vessel disease or blood clots, have thick blood, or have been immobile for some time.
Slovenian: Zdravniku povejte, če imate bolezni srca ali ožilja ali krvne strdke v anamnezi, zgoščeno kri ali če ste dlje časa nepokretni.
English: Responder: in the pump-assisted group a subject who performed ≥3 valid infusions out of 4 for an infusion parameter; in the manual push group a subject who performed ≥60 % of valid infusions for an infusion parameter.
Slovenian: Odzivnik: v skupini z infundiranjem s pomočjo črpalke: oseba, ki je od 4 opravila ≥ 3 veljavna infundiranja za en parameter infundiranja; v skupini z ročnim potiskanjem: oseba, ki je opravila ≥ 60 % veljavnih infundiranj za en parameter infundiranja.
English: Transfer Hizentra to syringe for infusion - Attach a transfer device or needle to a sterile syringe, using aseptic technique.
Slovenian: Prenesite zdravilo Hizentra v brizgo za infundiranje - Pritrdite pripomoček za prenos ali iglo na sterilno brizgo, ob upoštevanju aseptične tehnike.
English: • you have switched from a different medicine
Slovenian: • ste se pred tem zdravili z drugim zdravilom
English: • you receive human normal immunoglobulin for the first time
Slovenian: • prvič prejemate humani polispecifični imunoglobulin
English: The recommended infusionrate given under section 3“How to use Hizentra” must be closely followed.
Slovenian: Upoštevati je treba priporočeno hitrost infundiranja v poglavju 3 »Kako uporabljati zdravilo Hizentra«.
English: 2 Assemble supplies Place Hizentra and other supplies and equipment needed for the infusion on a clean, flat surface.
Slovenian: 2 Pripravite vse pripomočke Položite zdravilo Hizentra ter druge pripomočke in opremo, potrebne za infundiranje, na čisto, ravno površino.
English: In the case of measles vaccinations the impairment may persist for up to 1 year.
Slovenian: Pri ošpicah lahko zmanjšana učinkovitost cepiva traja do 1leta.
English: Clean the vial stopper - Remove the protective cap from the vial to expose the central portion of the rubber stopper.
Slovenian: Očistite zamašek viale - Odstranite zaščitno zaporko z viale, da razkrijete osrednji del gumijastega zamaška.
English: The amount of product infused into a particular site may vary.
Slovenian: Količina zdravila, infundirana v določeno mesto, se lahko razlikuje.
English: • low immunoglobulin levels (hypogammaglobulinaemia) or absence of immunoglobulins (agammaglobulinaemia) in the blood
Slovenian: • nizke ravni imunoglobulinov (hipogamaglobulinemija) ali odsotnost imunoglobulinov (agamaglobulinemija) v krvi
English: If you notice such signs during the infusion of Hizentra, stop the infusion and go to the nearest hospital immediately.
Slovenian: Če med infundiranjem zdravila Hizentra opazite take znake, takoj prenehajte z infundiranjem in pojdite v najbližjo bolnišnico.
English: Then, insert the needle into the center of the vial stopper and, to avoid foaming, inject air into headspace of the vial (not into the liquid).
Slovenian: Da preprečite penjenje, vbrizgajte zrak v zgornji del viale (ne v tekočino).
English: Due to the study design, the same subject could receive both doses during the study; 72 subjects received doses of 0.4 g/kg and 73 subjects received doses of 0.2 g/kg during the efficacy evaluation period.
Slovenian: Zaradi zasnove študije je lahko isti preskušanec med študijo prejel oba odmerka; 72 preskušancev je v obdobju ovrednotenja učinkovitosti prejelo odmerek 0,4 g/kg in 73 preskušancev odmerek 0,2 g/kg.
English: • combination of low level or absence of immunoglobulins and absence or non-functional immune cells (severe combined immunodeficiency)
Slovenian: •kombinacija nizkih ravni ali odsotnosti imunoglobulinov in odsotnost ali nedelovanje imunskih celic (huda kombinirana imunska pomanjljivost)
English: If using a needle, pull back on the plunger to draw air into the syringe that is comparable to the amount of Hizentra to be withdrawn.
Slovenian: Če uporabljate iglo, povlecite bat nazaj, tako da brizgo napolnite z zrakom do količine, ki je enaka količini zdravila Hizentra, ki se jo bo povleklo iz viale.
English: What Hizentra is and what it is used for What you need to know before you use Hizentra How to use Hizentra
Slovenian: Kaj je zdravilo Hizentra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Hizentra Kako uporabljati zdravilo Hizentra Možni neželeni učinki
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Slovenian: Porazdelitev podrazredov imunoglobulina G je skoraj sorazmerna s porazdelitvijo v naravni človeški plazmi.
English: What Hizentra is and what it is used for
Slovenian: Kaj je zdravilo Hizentra in za kaj ga uporabljamo
English: In a third group, infusion volumes of 25, 40 and 50ml per site were additionally evaluated in pump-assisted administration of weekly Hizentra doses (n=15).
Slovenian: V tretji skupini so količine infundiranega zdravila 25, 40 in 50 ml na mesto infundiranja dodatno ovrednotili pri apliciranju tedenskih odmerkov zdravila Hizentra s pomočjo infuzijske črpalke (n=15).
English: Ask your healthcare professional how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: 172 adults with definite or probable CIDP who were previously treated with and responded to IVIg were randomised to weekly 0.2 g/kg bw Hizentra, weekly 0.4 g/kg bw Hizentra or placebo groups, and followed for a subsequent 24 weeks.
Slovenian: 172 odraslih s potrjeno ali verjetno CIDP, ki so bili predhodno zdravljeni z in so se odzivali na i.v.Ig, so randomizirali na tedensko uporabo zdravila Hizentra v odmerku 0,2 g/kg TM, tedensko uporabo zdravila Hizentra v odmerku 0,4 g/kg TM ali na skupino s placebom, in jih spremljali naslednjih 24 tednov.
English: System Organ Class (SOC, MedDRA)
Slovenian: Klasifikacija po organskih sistemih (MedDRA)
English: For dosing every two weeks, your doctor will double the weekly Hizentra dose.
Slovenian: Za odmerjanje na vsaka dva tedna bo vaš zdravnik podvojil tedenski odmerek zdravila Hizentra.
English: In the efficacy scores (INCAT score, mean grip strength, and Medical Research Council sum score), subjects in both Hizentra dose groups remained stable while subjects in the placebo group deteriorated.
Slovenian: Glede na oceno učinkovitosti (ocena po lestvici INCAT, povprečna moč stiska, in skupna ocena MRC (Medical Research Council) je stanje preiskovancev v obeh skupinah, ki sta dobivali odmerka zdravila Hizentra, ostalo stabilno, medtem ko se je pri preiskovancih v skupini s placebom poslabšalo.
English: If Hizentra is accidentally administered into a blood vessel, patients could develop shock.
Slovenian: Če se zdravilo Hizentra po nesreči da v žilo, se lahko pri bolniku razvije šok.
English: (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000),
Slovenian: Pogostnost na bolnika ali na infuzijo je bila ocenjena glede na naslednja merila: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: • You may use an unlimited number of sites simultaneously.
Slovenian: • Hkrati se lahko uporabi neomejeno število mest injiciranja.
English: The difference observed between the 0.2 g/kg bw and the 0.4 g/kg bw Hizentra groups did not reach statistical significance.
Slovenian: Razlika, ki so jo opazili med odmerkoma zdravila Hizentra 0,2 g/kg TM in 0,4 g/kg TM, ni bila statistično pomembna.
English: If you notice such signs during the infusion of Hizentra, stop the infusion and contact your doctor or go to the nearest hospital immediately.
Slovenian: Če med infundiranjem zdravila Hizentra opazite take znake, takoj prenehajte z infundiranjem in se posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
English: The initial subcutaneous dose may be a 1:1 conversion from the previous IVIG dose (calculated as weekly dose).
Slovenian: Začetni subkutani odmerek je lahko pretvorba v razmerju 1:1 enot glede na prej uporabljani odmerek i.v.Ig (izračunan kot tedenski odmerek).
English: ADR frequency category per infusion
Slovenian: Kategorija pogostnosti NUZ na infuzijo
English: 30 ml/hour/site 60 ml/hour/site 120 ml/hour/site
Slovenian: 30 ml/uro/mesto 60 ml/uro/mesto 120 ml/uro/mesto
English: Example a 1g/kg IVIG dose given every 3 weeks would convert into a 0.33g/kg weekly Hizentra dose.
Slovenian: Primer: odmerek i.v.Ig 1 g/kg, dan vsake 3 tedne, bi pretvorili v tedenski odmerek zdravila Hizentra 0,33 g/kg.
English: Down-titrating patients in the extension study who completed the PATH study on either dose from 0.4 g/kg to 0.2 g/kg bw dose was possible in 67.9 % of subjects (19/28 patients) without occurrence of relapse; all of the 9 relapsers recovered within 4 weeks after treatment with 0.4 g/kg bw dose.
Slovenian: Titriranje odmerkov navzdol pri bolnikih v podaljšani študiji, ki so zaključili študijo PATH bodisi z odmerkom 0,4 g/kg bodisi 0,2 g/kg telesne mase, je bilo možno pri 67,9 % preskušancev (19/28 bolnikov) brez pojava relapsa; pri vseh 9 bolnikih, pri katerih se je pojavil relaps, se je stanje izboljšalo v 4 tednih po zdravljenju z odmerkom 0,4 g/kg telesne mase.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Prime the tubing to eliminate all remaining air.
Slovenian: Iz cevke odstranite ves preostali zrak.
English: ADR frequency category per patient
Slovenian: Kategorija pogostnosti NUZ na bolnika
English: Tell your doctor or healthcare professional prior to treatment if you have experienced an intolerance against one of these components earlier.
Slovenian: Pred zdravljenjem zdravniku ali zdravstvenemu delavcu povejte, če ste imeli v preteklosti preobčutljivost na katero od teh sestavin.
English: Following subcutaneous administration of Hizentra, peak serum levels are achieved after approximately 2 days.
Slovenian: Absorpcija in porazdelitev Po subkutanem dajanju zdravila Hizentra se najvišje serumske ravni dosežejo po približno 2 dneh.
English: The medicinal product should be brought to room or body temperature before use.
Slovenian: Zdravilo je treba pred uporabo segreti na sobno ali telesno temperaturo.
English: Side effects observed in post-marketing are of unknown frequency:
Slovenian: Neželeni učinki, ki so bili opaženi po prihodu zdravila na trg, so neznane pogostnosti:
English: • Do not use this medicine after the expiry date which is stated on the outer carton and the pre filled syringe label after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in nalepki na napolnjeni injekcijski brizgi poleg oznake EXP.
English: Treatment of low immunoglobulin levels and recurrent bacterial infections in patients with multiple myeloma (MM), another kind of blood cancer.
Slovenian: Zdravljenje nizkih ravni imunoglobulinov in ponavljajočih se bakterijskih okužb pri bolnikih z multiplim mielomom, drugo vrsto krvnega raka.
English: Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
Slovenian: Redko lahko humani polispecifični imunoglobulin sproži padec krvnega tlaka z anafilaktično reakcijo, tudi pri bolnikih, ki so prenašali predhodno zdravljenje s humanim polispecifičnim imunoglobulinom.
English: For dosing every two weeks, double the weekly Hizentra dose.
Slovenian: Za odmerjanje vsake 2 tedna podvojite tedenski odmerek zdravila Hizentra.
English: If you use more Hizentra than you should If you think you have had too much Hizentra, speak to your doctor as soon as possible.
Slovenian: Če ste uporabili večji odmerek zdravila Hizentra, kot bi smeli Če mislite, da ste uporabili preveč zdravila Hizentra, se čim prej posvetujte z zdravnikom.
English: 5, 10 or 20 ml of solution in a vial (type I glass) and 50 ml of solution in a vial (type II glass), with a stopper (halobutyl), a cap (aluminium crimp) and a flip off disc (plastic).
Slovenian: 5, 10 ali 20 ml raztopine v viali (steklo tipa I) in 50 ml raztopine v viali (steklo tipa II) z zamaškom (halobutilnim), zaporko (z aluminijastim navojem) in snemljivim pokrovčkom (plastičnim).
English: These simulations further suggested that comparable serum IgG trough levels can be achieved when the weekly maintenance dose of Hizentra is administered in proportional amounts more frequently than once a week (e.g. 2 times per week, 3 times per week, 5 times per week or daily).
Slovenian: Te simulacije nadalje nakazujejo, da je mogoče doseči primerljive najnižje ravni IgG v serumu z dajanjem tedenskih vzdrževalnih odmerkov zdravila Hizentra v sorazmernih količinah pogosteje kot enkrat na teden (npr. 2-krat na teden, 3-krat na teden, 5-krat na teden ali vsakodnevno).
English: • Abnormal result of a blood test that may indicate impaired liver and kidney function
Slovenian: • nenormalni rezultati krvnih preiskav lahko kažejo na oslabljeno delovanje jeter in ledvic
English: ► In isolated cases, you may experience pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body, sudden confusion, or trouble speaking or understanding could be signs of a blood clot.
Slovenian: ► V posamičnih primerih se lahko pojavijo boleče in/ali otekle roke ali noge s toploto na prizadetem predelu, obarvanje rok ali nog, nerazložena zasoplost, bolečine v prsnem košu ali nelagodje, ki se z globokim dihanjem slabša, nerazložen hiter utrip, omrtvelost ali šibkost po eni strani telesa, nenadna zmedenost ali težave pri govorjenju ali razumevanju so lahko znak krvnega strdka.