FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na sugamadeks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The bolus injection should be given rapidly, within 10 seconds, into an existing intravenous line (see section 6.6).
Slovenian: Bolusno injekcijo je treba dati hitro, v 10 sekundah, v že nastavljeno intravensko linijo (glejte poglavje 6.6).
English: • Light anaesthesia - you may start to come out of deep sleep, so need more anaesthesia.
Slovenian: • Blaga anestezija - lahko se boste začeli zbujati iz globokega spanca in boste potrebovali več anestetika.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki poleg oznake ‘EXP'.
English: • fusidic acid (an antibiotic).
Slovenian: • fusidno kislino (antibiotik).
English: These limited mean aPTT and PT(INR) prolongations were of short duration (≤ 30 minutes).
Slovenian: To manjše povprečno podaljšanje aPTT in PT(INR) je bilo kratkotrajno (≤ 30 minut).
English: Allergic reactions were reported more commonly in healthy, conscious volunteers
Slovenian: O alergijskih reakcijah so pogosteje poročali pri zdravih prostovoljcih pri zavesti.
English: A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.
Slovenian: Odmerek 16 mg/kg se lahko uporabi pri odraslih, kadar je potrebno nujno okrevanje iz mišične relaksacije.
English: Excretion via faeces or expired air was less than 0.02% of the dose.
Slovenian: Izločanje zdravila z blatom ali izdihanim zrakom je znašalo manj kot 0,02 % odmerka.
English: • on coumarin derivates and at an INR above 3.5;
Slovenian: • ki jemljejo kumarinske derivate in imajo pri tem vrednost INR nad 3,5;
English: Hormonal contraceptives:
Slovenian: Hormonski kontraceptivi:
English: Animal studies to evaluate fertility do not reveal harmful effects.
Slovenian: Študije pri živalih za oceno plodnosti pa niso pokazale škodljivih učinkov.
English: Limited data does not indicate differences in pharmacokinetic parameters in Black or African Americans.
Slovenian: Maloštevilni podatki ne kažejo razlik v farmakokinetičnih parametrih pri ameriških črncih oziroma Američanih afriškega izvora.
English: Pharmacotherapeutic group: all other therapeutic products, antidotes, ATC code: V03AB35
Slovenian: Farmakoterapevtska skupina: Druga zdravila, antidoti, oznaka ATC: V03AB35
English: • toremifene (used to treat breast cancer).
Slovenian: • toremifen (ki ga uporabljamo za zdravljenje raka dojk),
English: Manufacturer • N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Slovenian: Organon, Kloosterstraat 6, 5349 AB Oss, Nizozemska
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden boste dobili zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: NL-5340 BH Oss The Netherlands
Slovenian: NL-5340 BH Oss Nizozemska
English: • Decreased blood pressure due to the surgical procedure
Slovenian: • Znižan krvni tlak zaradi kirurškega posega.
English: Selected patient characteristics
Slovenian: Izbrane značilnosti bolnika
English: The following information is intended for healthcare professionals only: For detailed information refer to the Summary of Product Characteristics of BRIDION.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Za podrobne informacije glejte Povzetek glavnih značilnosti zdravila BRIDION.
English: • with pre-existing coagulopathies;
Slovenian: • ki že imajo koagulopatijo;
English: • Return of muscle relaxation after the operation
Slovenian: • Ponoven pojav mišične relaksacije po operaciji.
English: Some medicines reduce the effect of Bridion → It is especially important that you tell your anaesthetist if you have recently taken:
Slovenian: Nekatera zdravila zmanjšajo učinek zdravila Bridion → Izredno pomembno je, da anesteziologu poveste, če ste pred kratkim jemali:
English: In patients receiving routine post-operative prophylactic anticoagulation this pharmacodynamic interaction is not clinically relevant.
Slovenian: Pri bolnikih, ki v času po operaciji prejemajo rutinsko preventivno antikoagulantno terapijo, ta farmakodinamična interakcija ni klinično pomembna.
English: Severe allergic or allergic-like reactions can be life threatening.
Slovenian: Hude alergijske ali alergijskim podobne reakcije so lahko smrtno nevarne.
English: Term newborn infants and infants:
Slovenian: Donošeni novorojenčki in dojenčki:
English: In these studies a clear dose-response relationship was observed.
Slovenian: V teh študijah so opazili jasno odvisnost odziva od odmerka zdravila.
English: Based on these data, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following:
Slovenian: Na podlagi teh podatkov ni pričakovati nikakršnih klinično pomembnih farmakodinamskih interakcij z drugimi zdravili, z naslednjimi izjemami:
English: For oestrogens, the effect is expected to be lower.
Slovenian: Pri estrogenskih kontraceptivih naj bi bil ta učinek manjši.
English: Bridion can affect hormonal contraceptives
Slovenian: Zdravilo Bridion lahko vpliva na hormonske kontraceptive
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/plodu, plod ali postnatalni razvoj.
English: Interference with laboratory tests:
Slovenian: Motnje laboratorijskih preiskav:
English: If more than 2.4 mL solution needs to be administered, this should be taken into consideration by patients on a controlled sodium diet.
Slovenian: Če morate bolniku dati več kot 2,4 ml raztopine, je treba to upoštevati predvsem pri bolnikih na dieti z nadzorovano količino natrija.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja razredčenega zdravila glejte poglavje 6.3.
English: • if you have diseases which are known to give an increased risk of bleeding (disturbances of blood clotting) or anticoagulation medication.
Slovenian: • če imate bolezni, za katere je znano, da povečajo tveganje za krvavitve (motnje strjevanja krvi),
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če zdravilo ni uporabljeno takoj, je za čas shranjevanja med uporabo in pogoje shranjevanja zdravila pred uporabo odgovoren sam uporabnik, in naj čas normalno ne bi presegel 24 ur pri temperaturi med 2 °C in 8 °C, razen če je redčenje potekalo v nadzorovanih in validiranih aseptičnih pogojih.
English: It is given as a single injection through an intravenous line.
Slovenian: Zdravilo se daje v obliki enkratne injekcije skozi intravensko linijo.
English: The dose of Bridion for children is 2 mg/kg (children and adolescents between 2-17 years old).
Slovenian: Odmerek zdravila Bridion za otroke je 2 mg/kg (otroci in mladostniki stari 2 - 17 let).
English: Bridion may affect other medicines or be affected by them.
Slovenian: Zdravilo Bridion lahko vpliva na druga zdravila in druga zdravila lahko vplivajo nanj.
English: Studies in patients with hepatic impairment have not been conducted.
Slovenian: Študije pri bolnikih z jetrno okvaro niso bile opravljene.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih posodobitvah RMP.
English: Based upon clinical studies, sugammadex concentrations in plasma are reduced by up to 70% after a 3 to 6-hour dialysis session.
Slovenian: Na podlagi kliničnih študij so ugotovili, da se koncentracija sugamadeksa v plazmi zmanjša za do 70 % po 3 do 6 urah dialize.
English: In a study in healthy Japanese and Caucasian subjects no clinically relevant differences in pharmacokinetic parameters were observed.
Slovenian: V študiji pri zdravih Japoncih in belcih niso opazili nikakršnih klinično pomembnih razlik v farmakokinetičnih parametrih zdravila.
English: Marked bradycardia:
Slovenian: Izrazita bradikardija:
English: Patients on a controlled sodium diet:
Slovenian: Bolniki na dieti z nadzorovano količino natrija:
English: It can be used in adults whenever rocuronium bromide or vecuronium bromide is used and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for a moderate level of relaxation.
Slovenian: Lahko se uporablja pri odraslih, kadar koli je uporabljen rokuronijev bromid ali vekuronijev bromid, in pri otrocih in mladostnikih (starih od 2 do 17 let), kadar je rokuronijev bromid uporabljen za zmerno stopnjo mišične sprostitve.
English: Two open label studies compared the efficacy and safety of sugammadex in surgical patients with and without severe renal impairment.
Slovenian: V dveh odprtih študijah so primerjali učinkovitost in varnost sugamadeksa pri kirurških bolnikih z ali brez hude ledvične okvare.
English: Clinicians should be aware that the recovery of the T4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation.
Slovenian: Zdravniki se morajo zavedati, da bo zato povrnitev razmerja T4/T1 na 0,9 lahko zakasnjena pri bolnikih, ki bodo na dan operacije prejeli tudi toremifen.
English: Preclinical studies in young adult and mature rats demonstrate that sugammadex does not adversely affect tooth colour or bone quality, bone structure, or bone metabolism.
Slovenian: Predklinične študije na mladih odraslih in odraslih podganah so pokazale, da sugamadeks nima negativnega vpliva na barvo ali kakovost zob, strukturo ali metabolizem kosti.
English: Clearance (mL/min)
Slovenian: Očistek (ml/min)
English: In clinical trials of surgical patients these reactions were reported uncommonly and for post-marketing reports the frequency is unknown.
Slovenian: V kliničnih preskušanjih pri kirurških bolnikih so o teh reakcijah poročali občasno, v okviru postmarketinških izkušenj pa je njihova pogostnost neznana.
English: If there is a medical need to give sugammadex to these patients the anaesthesiologist needs to decide if the benefits outweigh the possible risk of bleeding complications taking into consideration the patients history of bleeding episodes and type of surgery scheduled.
Slovenian: Če obstaja medicinska potreba po dajanju sugamadeksa tem bolnikom, mora anesteziolog presoditi, ali koristi njegove uporabe odtehtajo morebitno tveganje za hemoragične zaplete, ob upoštevanju bolnikove anamneze o krvavitvah in vrste načrtovanega kirurškega posega.
English: The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available.
Slovenian: Uporabe sugamadeksa pri donošenih novorojenčkih in pri dojenčkih torej ne priporočamo, dokler ne bo na voljo več podatkov.
English: Bridion is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier.
Slovenian: Zdravilo Bridion uporabljamo za pospešitev okrevanja vaših mišic po operaciji, da bi lahko prej samostojno zadihali.
English: Adverse reactions (Preferred terms)
Slovenian: Neželeni učinki (priporočeni izrazi)
English: Studies in patients with severe renal impairment do not provide sufficient safety information to support the use of sugammadex in these patients (see also section 5.1).
Slovenian: S študijami, izvedenimi pri bolnikih s hudo ledvično okvaro, ni bilo pridobljenih dovolj podatkov glede varnosti v podporo uporabi sugamadeksa pri teh bolnikih (glejte tudi poglavje 5.1).
English: The data for the paediatric population are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2).
Slovenian: Podatkov za pediatrično populacijo je malo (samo ena študija za prekinitev z rokuronijem povzročene blokade pri ponovnem pojavu T2).
English: • Severe slowing of the heart and slowing of the heart up to cardiac arrest may occur when
Slovenian: • Huda upočasnitev srca in upočasnitev srca vse do srčnega zastoja se lahko pojavita pri uporabi zdravila Bridion.
English: • Bridion can make hormonal contraceptives - including the ‘Pill', vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone.
Slovenian: • Zdravilo Bridion lahko zmanjša učinkovitost hormonskih kontraceptivov - vključno s "tabletkami", vaginalnim obročkom, implantati (vsadki) ali hormonskimi znotrajmaterničnimi sistemi (IUS), - ker zmanjšuje količino hormona progestogena, ki ga dobite.
English: Severe hypersensitivity reactions can be fatal.
Slovenian: Hude preobčutljivostne reakcije so lahko smrtno nevarne.
English: The observed steady-state volume of distribution of sugammadex is approximately 11 to 14 litres in adult patients with normal renal function (based on conventional, non-compartmental pharmacokinetic analysis).
Slovenian: Opaženi porazdelitveni volumen sugamadeksa v stanju dinamičnega ravnovesja znaša približno 11 do 14 litrov pri odraslih bolnikih z normalnim delovanjem ledvic (na podlagi konvencionalne, neprostorne farmakokinetične analize).
English: For re-administration of sugammadex see section 4.2.
Slovenian: Za navodila o ponovni uporabi sugamadeksa glejte poglavje 4.2.
English: There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and term newborn infants (less than 30 days) have not been studied.
Slovenian: Izkušenj z uporabo sugamadeksa pri dojenčkih (starih od 30 dni do 2 let) je malo, pri donošenih novorojenčkih (starih manj kot 30 dni) pa njegove uporabe niso proučevali.
English: The safety of sugammadex has been evaluated in 3,519 unique subjects across a pooled phase I-III safety database.
Slovenian: Varnost sugamadeksa so ovrednotili pri 3.519 posameznikih na podlagi združene podatkovne baze o varnosti zdravila iz študij faz I-III.
English: N.V. Organon Kloosterstraat 6 P.O.
Slovenian: Organon Kloosterstraat 6 P.O. Box 20
English: • Allergic (drug hypersensitivity) reactions - such as a rash, red skin, swelling of your tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, sometimes resulting in a serious decrease of blood pressure.
Slovenian: • Alergijske (preobčutljivostne) reakcije na zdravilo, kot na primer izpuščaj, pordela koža, otekanje jezika in/ali žrela, kratka sapa, spremembe krvnega tlaka ali frekvence srca, ki včasih vodijo do resnega znižanja krvnega tlaka.
English: As with all patients with a history of pulmonary complications the physician should be aware of the possible occurrence of bronchospasm.
Slovenian: Kot pri vseh bolnikih z anamnezo o pljučnih zapletih se mora tudi tu zdravnik zavedati možnosti za pojav bronhospazma.
English: If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg.
Slovenian: Če je potreben krajši čas, mora biti odmerek rokuronija za novo živčnomišično blokado 1,2 mg/kg.
English: What Bridion looks like and contents of the pack Bridion is a clear and colourless to slightly yellow solution for injection.
Slovenian: Izgled zdravila Bridion in vsebina pakiranja Bridion je bistra in brezbarvna do rahlo rumena raztopina za injiciranje.
English: Oral absorption of cyclodextrins in general is low and no effect on the suckling child is anticipated following a single dose to the breast-feeding woman.
Slovenian: Peroralna absorpcija ciklodekstrinov je na splošno majhna, zato ni pričakovati nobenega učinka na dojenčka po dajanju enkratnega odmerka zdravila doječim materam.
English: The use of lower than recommended doses may lead to an increased risk of recurrence of neuromuscular blockade after initial reversal and is not recommended (see section 4.2 and section 4.8).
Slovenian: Uporaba odmerkov, ki so manjši od priporočenih, lahko vodi do povečanega tveganja za ponovitev živčnomišične blokade po prvotni prekinitvi in ni priporočljiva (glejte poglavji 4.2 in 4.8).
English: Clinicians should be prepared for the possibility of drug hypersensitivity reactions (including anaphylactic reactions) and take the necessary precautions (see section 4.8).
Slovenian: Zdravnik mora biti pripravljen na možnost pojava preobčutljivostnih reakcij na zdravilo (vključno z anafilaktičnimi reakcijami) in mora uvesti potrebne previdnostne ukrepe (glejte poglavje 4.8).
English: What Bridion is and what it is used for
Slovenian: Kaj je zdravilo Bridion in za kaj ga uporabljamo
English: Pregnancy and breast-feeding → Tell your anaesthetist if you are pregnant or might be pregnant or if you are breast-feeding.
Slovenian: Nosečnost in dojenje → Povejte anesteziologu, če ste noseči ali bi lahko bili noseči, ali če dojite.
English: What Bridion is and what it is used for What you need to know before Bridion is given How Bridion is given
Slovenian: Kaj je zdravilo Bridion in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Bridion Kako se daje zdravilo Bridion Možni neželeni učinki
English: For sugammadex no clinical data on exposed pregnancies are available.
Slovenian: Za sugamadeks ni na voljo kliničnih podatkov za nosečnice, ki so bile izpostavljene zdravilu.
English: It is not known whether sugammadex can pass into breast milk.
Slovenian: Ni znano, ali sugamadeks lahko prehaja v materino mleko.
English: Population pharmacokinetic analysis of adult and elderly patients showed no clinically relevant relationship of clearance and volume of distribution with body weight.
Slovenian: Analiza populacijske farmakokinetike pri odraslih bolnikih in pri starostnikih ni pokazala nikakršne klinično pomembne odvisnosti očistka in porazdelitvenega volumna od telesne mase.
English: Total exposure to sugammadex was prolonged, leading to 17-fold higher exposure in patients with severe renal impairment.
Slovenian: Skupna izpostavljenost sugamadeksu je bila podaljšana, kar je povzročilo 17-krat večjo izpostavljenost pri bolnikih s hudo ledvično okvaro.
English: Recovery from blockade was modestly longer for patients with severe renal impairment relative to patients without renal impairment.
Slovenian: Okrevanje po blokadi je bilo malo daljše pri bolnikih s hudo ledvično okvaro, kot pri bolnikih brez ledvične okvare.
English: Re-administration of sugammadex:
Slovenian: Ponovna uporaba sugamadeksa:
English: The usual dose is 2-4 mg per kg body weight.
Slovenian: Običajen odmerek zdravila je od 2 do 4 mg na kg telesne mase.
English: Sugammadex can be removed using haemodialysis with a high flux filter, but not with a low flux filter.
Slovenian: Sugamadeks se lahko odstrani s hemodializo s filtrom z velikim pretokom, ne pa s filtrom z majhnim pretokom.
English: If sugammadex is administered to these patients monitoring of haemostasis and coagulation parameters is recommended.
Slovenian: Če tem bolnikom predpišete sugamadeks, je priporočljivo spremljanje hemostaze in parametrov koagulacije.
English: • Airway difficulties that may include coughing or moving as if you are waking or taking a breath
Slovenian: • Težave v dihalnih poteh, ki lahko vključujejo kašljanje ali premikanje kot pri prebujanju ali vdihu.
English: If such a situation is observed, the clinician is advised to consider the re-administration of the medicinal product, the administration of a therapeutically equivalent medicinal product (preferably from a different chemical class) and/or nonpharmacological interventions as appropriate.
Slovenian: Če opazite tak primer, svetujemo, da razmislite o ponovni uporabi zdravila, uporabi terapevtsko enakovrednega zdravila (najbolje iz druge kemijske skupine) in/ali nefarmakoloških ukrepih, odvisno od primera.
English: - The other ingredients are water for injections, hydrochloric acid 3.7% and/or sodium hydroxide.
Slovenian: - Druge sestavine zdravila so voda za injekcije, klorovodikova kislina 3,7 % ali/in natrijev hidroksid.
English: Renal function Creatinine clearance (mL/min)
Slovenian: Delovanje ledvic Očistek kreatinina (ml/min)
English: The interaction between 4 mg/kg sugammadex and a progestogen was predicted to lead to a decrease in progestogen exposure (34% of AUC) similar to the decrease seen when a daily dose of an oral contraceptive is taken 12 hours too late, which might lead to a reduction in effectiveness.
Slovenian: Napovedali so, da interakcije med sugamadeksom v odmerku 4 mg/kg in progestogenom vodijo do zmanjšane izpostavljenosti progestogenu (34 % vrednosti AUC), kar je podobno zmanjšanju v primerih, ko bolnica vzame svoj dnevni odmerek peroralnega kontraceptiva 12 ur prepozno, kar povzroči zmanjšanje učinkovitosti.
English: • Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of lung problems
Slovenian: • Težko dihanje zaradi krča mišic v dihalnih poteh (bronhospazem), ki se pojavlja pri bolnikih, ki so imeli v preteklosti težave s pljuči.
English: What you need to know before Bridion is given
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Bridion
English: In situations when potential displacement interactions can be anticipated, patients should be carefully monitored for signs of recurrence of neuromuscular blockade (approximately up to 15 minutes) after parenteral administration of another medicinal product occurring within a period of 7.5 hours after sugammadex administration.
Slovenian: V primerih, kjer lahko pričakujete morebitne interakcije zaradi izpodrivanja zdravila, je treba bolnike natančno opazovati glede znakov ponovitve živčnomišične blokade (približno do 15 minut) po parenteralni uporabi drugega zdravila v roku 7,5 ur po uporabi sugamadeksa.
English: → If you are using other hormonal contraceptives (for example a vaginal ring, implant or IUS) you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the advice in the package leaflet.
Slovenian: → Če uporabljate druga hormonska kontracepcijska sredstva (na primer vaginalni obroček, vsadek ali znotrajmaternični sistem), morate v naslednjih 7 dneh dodatno uporabljati katero od nehormonskih kontracepcijskih metod (na primer kondom) in upoštevati nasvete iz navodila za uporabo.
English: Other medicines and Bridion → Tell your anaesthetist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Bridion → Obvestite anesteziologa, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Bridion has no known influence on the ability to drive and use machines.
Slovenian: Zdravilo Bridion nima znanega vpliva na sposobnost vožnje in upravljanja s stroji.
English: Pulmonary patients:
Slovenian: Pljučni bolniki:
English: If more Bridion is given to you than recommended As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Bridion.
Slovenian: Če ste prejeli večji odmerek zdravila Bridion, kot je priporočljivo Ker bo anesteziolog natančno nadziral vaše stanje, je malo verjetno, da bi prejeli preveč zdravila Bridion, in tudi če se to zgodi, verjetno ne bo povzročilo nikakršnih težav.
English: Therefore the administration of a bolus dose of sugammadex is considered to be equivalent to one missed daily dose of oral contraceptive steroids (either combined or progestogen only).
Slovenian: Uporaba bolusnega odmerka sugamadeksa torej šteje za enakovredno enemu izpuščenemu dnevnemu odmerku peroralnega kontracepcijskega steroida (kombiniranega ali izključno progestogenskega).