FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use Orgalutran if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section6); if you are hypersensitive to gonadotrophin releasing hormone (GnRH) ora GnRH analogue; if you have a moderate or severe kidney or liver disease; if you are pregnant or breast-feeding.
Slovenian: Ne uporabljajte zdravila Orgalutran - če ste alergični na ganireliks ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste preobčutljivi na gonadotropin sproščujoči hormon (GnRH) ali katerega od analogov
English: The active substance ganirelix (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring gonadotrophin releasing hormone (GnRH).
Slovenian: Učinkovina ganireliks (INN) je sintetični dekapeptid z močnim antagonističnim delovanjem za naravni gonadotropin sproščujoči hormon (GnRH).
English: The needle cover contains dry natural rubber/latex which comes into contact with the needle and may cause allergic reactions.
Slovenian: Pokrovček igle vsebuje suho naravno gumo/lateks, ki pride v stik z iglo in lahko povzroči alergijske reakcije.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH VOJNINAH
English: Hypersensitivity reactions (including rash, facial swelling, dyspnoea, anaphylaxis (including anaphylactic shock), angioedema and urticaria) Worsening of a pre-existing eczema
Slovenian: Bolezni imunskega sistema zelo redki preobčutljivostne reakcije (vključno z izpuščajem, otekanjem obraza, dispnejo, anafilaksijo (vključno z anafilaktičnim šokom), angioedemom in urtikarijo) poslabšanje že obstoječega ekcema
English: Supplied in cartons containing 1 or 5 pre-filled syringes.
Slovenian: Pakirano v škatlah z 1 ali 5 napolnjenimi injekcijskimi brizgami.
English: Do not use if the solution contains particles or is not clear.
Slovenian: Če raztopina vsebuje delce ali če ni bistra, je ne smete uporabiti.
English: How to use Orgalutran
Slovenian: Kako uporabljati zdravilo Orgalutran
English: Orgalutran contains sodium Orgalutran contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo Orgalutran vsebuje manj kot 1 mmol (23 mg) natrija na injekcijo, kar v bistvu pomeni ‘brez natrija'.
English: Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation.
Slovenian: Ganireliks se uporablja za preprečevanje prezgodnjih vrhov sproščanja luteinizirajočega hormona (LH), ki bi lahko sicer nastali pri teh ženskah med stimulacijo jajčnikov.
English: Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG).
Slovenian: Končno zorenje foliklov se lahko sproži z dodajanjem humanega horionskega gonadotropina (hCG).
English: Orgalutran is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Slovenian: Zdravilo Orgalutran je indicirano za preprečevanje prezgodnjih vrhov sproščanja luteinizirajočega hormona (LH) pri ženskah, ki se zdravijo z nadzorovano hiperstimulacijo jajčnikov (COH - controlled ovarian hyperstimulation) pri postopkih oploditve z biomedicinsko pomočjo (ART - assisted reproduction techniques).
English: The pH may have been adjusted with sodium hydroxide and acetic acid.
Slovenian: pH (merilo kislosti) je lahko uravnan z natrijevim hidroksidom in ocetno kislino.
English: Vary the injection site with each injection.
Slovenian: Pri vsakem injiciranju zamenjajte mesto injiciranja.
English: Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland.
Slovenian: Zdravilo Orgalutran je antagonist GnRH, ki vpliva na hipotalamo-hipofizno-gonadno os s kompetitivno vezavo na receptorje GnRH v hipofizi.
English: Orgalutran should be administered subcutaneously, preferably in the upper leg.
Slovenian: Zdravilo Orgalutran je treba injicirati subkutano, najbolje v stegno.
English: The needle cover contains dry natural rubber/latex which comes into contact with the needle.
Slovenian: Pokrovček igle vsebuje suho naravno gumo/lateks, ki pride v stik z iglo.
English: In clinical studies Orgalutran was used with recombinant follicle stimulating hormone (FSH) or corifollitropin alfa, a follicle stimulant with a long duration of action.
Slovenian: V kliničnih študijah se je zdravilo Orgalutran uporabljalo z rekombinantnim folikle stimulirajočim hormonom (FSH) ali s korifolitropinom alfa, dolgo delujočim stimulatorjem foliklov.
English: Pinch up a large area of skin between finger and thumb.
Slovenian: S palcem in kazalcem privzdignite večji predel kože.
English: PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/0.5 mL
Slovenian: BESEDILO NA NAPOLNJENIH INJEKCIJSKIH BRIZGAH zdravila Orgalutran 0,25 mg/0,5 ml
English: Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
Slovenian: United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
English: Very Common Local skin reaction at the site of injection (predominantly redness, with or without swelling)
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti lokalne kožne reakcije na mestu injiciranja (predvsem pordelost z ali brez otekline)
English: Worsening of a pre-existing rash (eczema) has been reported in one subject after the first Orgalutran dose.
Slovenian: • koprivnica (urtikarija) - poslabšanje že obstoječega izpuščaja (ekcema), o katerem so poročali pri eni osebi po prejetem prvem odmerku zdravila Orgalutran.
English: What Orgalutran contains
Slovenian: Zdravilo Orgalutran vsebuje natrij
English: Orgalutran contains the active substance ganirelix and belongs to a group of medicines called “antigonadotrophin-releasing hormones” which act against the actions of the natural gonadotrophin releasing hormone (GnRH).
Slovenian: Zdravilo Orgalutran vsebuje učinkovino ganireliks in spada v skupino antagonistov gonadotropin sproščujočih hormonov, ki delujejo tako, da nasprotujejo delovanju naravnega gonadotropin sproščujočega hormona (GnRH).
English: Orgalutran inhibits the action of GnRH, resulting in suppression of the release of especially LH.
Slovenian: Zdravilo Orgalutran zavira delovanje GnRH, kar povzroči zaviranje sproščanja predvsem luteinizirajočega hormona (LH).
English: Therefore, when injecting Orgalutran in the morning treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation.
Slovenian: Zato morate pri injiciranju zdravila Orgalutran zjutraj z zdravljenjem z njim nadaljevati ves čas terapije z gonadotropini, vključno z dnem sproženja ovulacije.
English: Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes.
Slovenian: Ganireliks se uporablja pri ženskah, ki se zdravijo z nadzorovano hiperstimulacijo jajčnikov pri postopkih oploditve z biomedicinsko pomočjo.
English: Therefore, when injecting Orgalutran in the morning, treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation.
Slovenian: Če torej injicirate zdravilo Orgalutran zjutraj, nadaljujte z zdravljenjem z njim ves čas zdravljenja z gonadotropinom, vključno z dnem, ko se sproži ovulacija.
English: Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased.
Slovenian: Ker imajo neplodne ženske v postopku oploditve z biomedicinsko pomočjo, posebno pri zunajtelesni oploditvi (IVF), pogosto prizadete jajcevode, je pri njih povečana pogostnost zunajmaternične nosečnosti, zato je zgodnja ultrazvočna preiskava, ki potrjuje maternično nosečnost, zelo pomembna.
English: Multiple births or birth defects
Slovenian: Večplodna nosečnost ali prirojene nepravilnosti
English: The incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions.
Slovenian: Pogostnost pojavljanja prirojenih nepravilnosti v razvoju raznih delov telesa po postopku oploditve z biomedicinsko pomočjo je lahko rahlo večja kot po spontanih zanositvah.
English: The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions.
Slovenian: Pri postopkih oploditve z biomedicinsko pomočjo (ART) je lahko pogostnost prirojenih deformacij večja kot po spontani zanositvi.
English: Cases of hypersensitivity reactions (both generalised and local), have been reportedwith Orgalutran, as early as with the first dose, during post-marketing surveillance.
Slovenian: V obdobju trženja zdravila Orgalutran so poročali o primerih preobčutljivostnih reakcij (generaliziranih in lokalnih) že pri prvem odmerku.
English: MSD France
Slovenian: MSD France Tél.
English: The efficacy and safety of Orgalutran has not been established in women weighing less than 50 kg or more than 90 kg.
Slovenian: Učinkovitost in varnost zdravila Orgalutran nista bili dokazani pri ženskah s telesno maso manjšo od 50 kg ali večjo od 90 kg. Vprašajte zdravnika za nadaljnje informacije.
English: How to store Orgalutran
Slovenian: Shranjevanje zdravila Orgalutran
English: These events have included anaphylaxis (including anaphylactic shock), angioedema and urticaria.
Slovenian: Ti primeri so vključevali anafilaksijo (vključno z anafilaktičnim šokom), angioedem in urtikarijo (glejte poglavje 4.8).
English: Cases have been reported, as early as with the first dose, among patients administered Orgalutran.
Slovenian: O teh primerih so poročali pri bolnikih že po prejetem prvem odmerku zdravila Orgalutran.
English: Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques (ART).
Slovenian: Zdravilo Orgalutran se uporablja med nadzorovano stimulacijo jajčnikov pri postopkih oploditve z biomedicinsko pomočjo (ART - assisted reproduction techniques).
English: Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 mL aqueous solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 0,25 mg ganireliksa v 0,5 ml vodne raztopine.
English: Injection site
Slovenian: Mesto injiciranja
English: Orgalutran 0.25 mg/0.5 mL solution for injection
Slovenian: Orgalutran 0,25 mg/0,5 ml raztopina za injiciranje
English: Each pre-filled syringe is affixed with a needle closed by a needle cover of dry natural rubber/latex which comes into contact with the needle.
Slovenian: Vsaka napolnjena injekcijska brizga ima pritrjeno iglo, pokrito z zaščitnim pokrovčkom iz suhe naravne gume/lateksa, ki pride v stik z iglo (glejte poglavje 4.4).
English: Orgalutran 0.25 mg/0.5 mL solution for injection Ganirelix
Slovenian: Orgalutran 0,25 mg/0,5 ml raztopina za injiciranje ganireliks
English: The active substance is ganirelix (0.25 mg in 0.5 mL solution).
Slovenian: Kaj vsebuje zdravilo Orgalutran - Učinkovina je ganireliks (0,25 mg v 0,5 ml raztopine).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Orgalutran
Slovenian: Pred začetkom uporabe zdravila Orgalutran se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro
English: The injection site should be varied to prevent lipoatrophy.
Slovenian: Mesto injiciranja spreminjajte, da preprečite atrofijo maščevja.
English: Uncommon: may affect up to 1 in 100 women Headache
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnic - glavobol, - slabost, - slabo počutje.
English: Orgalutran and FSH should be administered approximately at the same time.
Slovenian: Zdravilo Orgalutran in FSH je treba aplicirati približno ob istem času, vendar zdravil ne smete mešati v isti brizgi in morate uporabiti različni injekcijski mesti.
English: Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation.
Slovenian: Med stimulacijo jajčnikov ali po njej se lahko pojavi sindrom hiperstimulacije jajčnikov (OHSS - Ovarian hyperstimulation syndrome).
English: Orgalutran is used to prevent premature LH surges in women undergoing COH.
Slovenian: Orgalutran se uporablja za preprečevanje prezgodnjih vrhov sproščanja LH pri ženskah, ki se zdravijo z nadzorovano hiperstimulacijo jajčnikov (COH).
English: Orgalutran is used for
Slovenian: Zdravilo Orgalutran uporabljamo
English: Clear and colourless aqueous solution.
Slovenian: raztopina za injiciranje bistra in brezbarvna vodna raztopina
English: D-hArg(Et2)
Slovenian: (Et2)
English: Nervous system disorders
Slovenian: Injiciranje raztopine
English: Hepatic impairment
Slovenian: Bolezni živčevja občasni glavobol
English: Therefore, the use of Orgalutran is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
Slovenian: Ni izkušenj z uporabo zdravila Orgalutran pri bolnicah z okvaro jeter, ker so le-te izključili iz kliničnih študij, zato je uporaba zdravila Orgalutran kontraindicirana pri bolnicah z zmerno ali hudo okvaro jeter (glejte poglavje 4.3).
English: Therefore, the use of Orgalutran is contraindicated in patients with moderate or severe renal impairment (see section 4.3).
Slovenian: Ni izkušenj z uporabo zdravila Orgalutran pri bolnicah z okvaro ledvic, ker so le-te izključili iz kliničnih študij, zato je uporaba zdravila Orgalutran kontraindicirana pri bolnicah z zmerno ali hudo okvaro ledvic (glejte poglavje 4.3).
English: Uncommon Headache
Slovenian: občasni slabo počutje
English: Faeces only contain metabolites.
Slovenian: V blatu se pojavijo le presnovki.
English: However, the preparations should not be mixed and different injection sites are to be used.
Slovenian: Zdravilo Orgalutran in FSH je treba injicirati ob približno istem času, vendar teh zdravil ne smemo mešati med seboj in moramo uporabiti različna mesta injiciranja.
English: The pH (a measurement of the acidity) may have been adjusted with sodium hydroxide and acetic acid.
Slovenian: 6.1 Seznam pomožnih snovi ocetna kislina manitol voda za injekcije pH je lahko uravnan z natrijevim hidroksidom in ocetno kislino.
English: Approximately half of the patients in each group were male.
Slovenian: Približno polovica bolnikov v obeh skupinah je bila moških.
English: Older people/Sex/Race
Slovenian: Starejše osebe/spol/rasa
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2015
Slovenian: Datum prve odobritve: 20. november 2015
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1056/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1056/001
English: The safety and efficacy of Praxbind in children below the age of 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Praxbind pri otrocih, starih do 18 let, še nista bili dokazani.
English: Your doctor or nurse will give you this medicine by injection or infusion into a vein.
Slovenian: Zdravnik ali medicinska sestra vam bo to zdravilo dala v veno z injekcijo ali infuzijo.
English: In single cases the transient proteinuria persisted for more than 24 hours.
Slovenian: V posameznih primerih je prehodna proteinurija trajala več kot 24 ur.
English: • In life-threatening or uncontrolled bleeding.
Slovenian: • pri življenjsko nevarnih ali nenadzorovanih krvavitvah.
English: The highest single dose of Praxbind studied in healthy subjects was 8 g. No safety signals have been identified in this group.
Slovenian: Največji enkratni odmerek zdravila Praxbind pri zdravih preizkušancih je bil 8 g. V tej skupini niso zasledili nobenih varnostnih signalov.
English: • The enclosed package leaflet contains additional information for healthcare professionals
Slovenian: • Priloženo navodilo za uporabo vsebuje dodatne informacije za zdravstveno osebje.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba zabeležiti ime in številko serije uporabljenega zdravila.
English: Each pack contains two vials.
Slovenian: Eno pakiranje vsebuje dve viali.
English: A maximum daily dose has not been investigated.
Slovenian: Največjega dnevnega odmerka niso proučevali.
English: The median age was 78 years and the median creatinine clearance was 52.6 mL/min.
Slovenian: Mediana starosti je bila 78 let in mediana kreatininskega očistka je bila 52,6 ml/min.
English: 61.5% of patients in Group A and 62.4% of patients in Group B had been treated with dabigatran 110 mg twice daily.
Slovenian: 61,5 % bolnikov iz skupine A in 62,4 % bolnikov iz skupine B je bilo zdravljenih z dabigatranom 110 mg dvakrat dnevno.
English: • For emergency surgery/urgent procedures
Slovenian: • za nujne operacije/nujne posege;
English: Handling instructions:
Slovenian: Navodila za ravnanje:
English: This medicine is for hospital use only.
Slovenian: To zdravilo je samo za bolnišnično uporabo.
English: In this case, the substance sorbitol contained in this medicine may cause serious adverse reactions.
Slovenian: V tem primeru lahko snov sorbitol, ki jo to zdravilo vsebuje, povzroči resne neželene učinke.
English: Of the total 503 patients, 101 patients died; each of these deaths could be attributed either as a complication of the index event or associated with co-morbidities.
Slovenian: Od skupno 503 bolnikov jih je umrlo 101; vsako izmed teh smrti lahko pripišemo bodisi komplikaciji zdravljenega dogodka ali povezanosti s sočasnimi obolenji.
English: Therefore, preclinical results do not suggest a risk to fertility or embryo-fetal development.
Slovenian: Zato predklinični rezultati ne kažejo na tveganje za plodnost ali embrio-fetalni razvoj.
English: Reproductive and developmental toxicity studies have not been performed, given the nature and the intended clinical use of the medicinal product.
Slovenian: Študij toksičnosti za razmnoževanje in razvoj niso izvedli zaradi narave in nameravane klinične uporabe zdravila.
English: All pigs survived at idarucizumab doses of approximately 2.5 and 5 g. Without idarucizumab, the mortality in the anticoagulated group was 100 %.
Slovenian: Vsi prašiči so preživeli odmerke idarucizumaba po približno 2,5 in 5 g. Brez idarucizumaba je smrtnost v antikoagulirani skupini znašala 100 %.
English: Read all of this leaflet carefully, because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Pharmacotherapeutic group: all other therapeutic products, antidotes, ATC code: V03AB37
Slovenian: Farmakoterapevtska skupina: druga zdravila, antidoti, oznaka ATC: V03AB37
English: Urinary protein testing
Slovenian: Preiskave urina na prisotnost beljakovin
English: All of these pathways involve biodegradation of the antibody to smaller molecules, i.e. small peptides or amino acids, which are then reabsorbed and incorporated in the general protein synthesis.
Slovenian: Vse poti vključujejo biodegradacijo protitelesa v manjše molekule, tj. manjše peptide ali aminokisline, ki se potem reabsorbirajo in vgradijo v splošno sintezo proteinov.
English: It is unlikely that Praxbind will influence the effect of other medicines or that other medicines will influence Praxbind.
Slovenian: Ni verjetno, da bi zdravilo Praxbind vplivalo na učinek drugih zdravil ali da bi druga zdravila vplivala na učinek zdravila Praxbind.
English: Restoration of haemostasis was achieved in 80.3% of evaluable patients who had serious bleeding and normal haemostasis was observed in 93.4% of patients who required an urgent procedure.
Slovenian: Ponovna vzpostavitev hemostaze je bila dosežena pri 80,3 % pregledanih bolnikih, ki so imeli resne krvavitve, normalna hemostaza pa je bila opažena pri 93,4 % bolnikih, ki so potrebovali nujni poseg.
English: The remaining part of the dose is assumed to be eliminated via protein catabolism, mainly in the kidney.
Slovenian: Predvidevajo, da se preostali odmerek izloči s proteinskim katabolizmom, pretežno v ledvicah.
English: Praxbind does not affect any functions in the body as such, so your doctor may decide to give you this medicine, if the expected benefits outweigh any potential risks.
Slovenian: Zdravilo Praxbind ne vpliva na delovanje funkcij telesa kot takega, zato se lahko vaš zdravnik odloči, da ga pri vas uporabi, če so pričakovane koristi večje od možnih tveganj.
English: A key secondary endpoint was the restoration of haemostasis.
Slovenian: Ključni sekundarni opazovani dogodek je bil ponovna vzpostavitev hemostaze.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Za čas in pogoje shranjevanja zdravila, ki se ga ne porabi takoj, je odgovoren uporabnik.
English: In these studies the doses of idarucizumab ranged from 20 mg to 8 g and the infusion times ranged from 5 minutes to 1 hour.
Slovenian: V teh študijah je bil razpon odmerkov idarucizumaba od 20 mg do 8 g in razpon časa infundiranja od 5 minut do 1 ure.
English: Thrombotic events were reported in 34 patients (23 out of the 34 patients were not on antithrombotic therapy at the time of the event) and in each of these cases, the thrombotic event could be attributed to the underlying medical condition of the patient.
Slovenian: O trombotičnih dogodkih so poročali pri 34 bolnikih (23 od 34 bolnikov v času dogodka ni prejemalo antitrombotične terapije) in pri vsakem izmed teh primerov so trombotični dogodek lahko pripisali osnovni bolnikovi bolezni.
English: Safety pharmacology studies have demonstrated no effects on the respiratory, central nervous or cardiovascular system.
Slovenian: Študije farmakološke varnosti niso pokazale učinkov na dihala, osrednje živčevje ali na srčnožilni sistem.
English: Dabigatran exerts pronounced effects on parameters of the endogenous thrombin potential (ETP).
Slovenian: Dabigatran ima izrazite učinke na parametre endogenega trombinskega potenciala (ETP).
English: Praxbind may be used during pregnancy, if the expected clinical benefit outweighs the potential risks.
Slovenian: Uporaba zdravila Praxbind je med nosečnostjo mogoča, če je pričakovana klinična korist večja od možnih tveganj.
English: A value above the normal range may reflect residual active dabigatran or other clinical conditions e.g., presence of other drugs or transfusion coagulopathy.
Slovenian: Vrednost nad normalnim območjem lahko kaže na preostali aktiven dabigatran ali druga klinična stanja, npr. prisotnost drugih zdravil ali transfuzijske koagulopatije.
English: RE-VERSE AD included data for 503 patients: 301 patients with serious bleeding (Group A) and 202 patients requiring an urgent procedure/surgery (Group B).
Slovenian: Študija RE-VERSE AD je vključevala podatke 503 bolnikov: 301 bolnika z resnimi krvavitvami (skupina A) in 202 bolnika, ki so potrebovali nujen poseg/operacijo (skupina B).
English: This is equivalent to 2.5 % of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enakovredno 2,5 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: The investigated population consisted of healthy subjects and subjects exhibiting specific population characteristics covering age, body weight, race, sex and renal impairment.
Slovenian: Proučevano populacijo so sestavljali zdravi preizkušanci in tisti s specifičnimi populacijskimi značilnostmi: starost, telesna masa, rasa, spol in ledvična okvara.
English: All nine patients were redosed within 6 days after the first idarucizumab dose.
Slovenian: Vseh devet bolnikov je ponovno prejelo odmerek v 6 dneh po prvem odmerku idarucizumaba.
English: In rare cases you may still have too much dabigatran in your blood after a first dose of Praxbind and your doctor may decide to give you a second 5 g dose in specific situations.
Slovenian: V redkih primerih imate morda po prvem odmerku zdravila Praxbind še vedno preveč dabigatrana v krvi in se bo vaš zdravnik v določenih okoliščinah morda odločil za ponovni 5 g odmerek.