FrancophonIA/ELRC3.0 huggingface dataset:
English: However, due to Tecfidera immunomodulatory properties (see section 5.1), if a patient develops a serious infection, suspending treatment with Tecfidera should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Slovenian: premisliti o začasni prekinitvi zdravljenja z zdravilom Tecfidera in pred ponovno uvedbo zdravljenja spet oceniti koristi in tveganja, če se pri bolniku razvije resna okužba.
English: There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or <0.5x109/L (see Section 4.8).
Slovenian: Pri bolnikih s številom limfocitov < 0,8 x 109/l ali < 0,5 x 109/l niso opazili zvišanja incidence resnih okužb (glejte poglavje 4.8).
English: Concurrent therapy with nephrotoxic medicinal products (such as aminoglycosides, diuretics, nonsteroidal anti-inflammatory drugs or lithium) may increase the potential of renal adverse reactions (e.g. proteinuria see section 4.8) in patients taking Tecfidera (see section 4.4 Blood/laboratory tests).
Slovenian: Sočasno zdravljenje z nefrotoksičnimi zdravili (kot so aminoglikozidi, diuretiki, nesteroidna protivnetna zdravila ali litij) lahko poveča možnost neželenih učinkov na ledvice (npr. proteinurija,
English: These may affect up to 1 in 100 people: - Allergic reactions (hypersensitivity) - reduction in blood platelets
Slovenian: - alergijske reakcije (preobčutljivost) - zmanjšanje števila trombocitov
English: Flushing and gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing and gastrointestinal events, these events may continue to occur intermittently throughout treatment with Tecfidera.
Slovenian: Vročinsko oblivanje in prebavni dogodki so se pojavili na začetku zdravljenja (v glavnem so se pojavili v prvem mesecu), pri čemer se lahko pri bolnikih, pri katerih se pojavi vročinsko oblivanje in prebavni dogodki, ti dogodki občasno pojavljajo ves čas zdravljenja z zdravilom Tecfidera.
English: Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes lasting for more than several days.
Slovenian: Simptomi lahko vključujejo novo nastalo ali poslabšano oslabelost ene strani telesa, okornost, spremembe vida,
English: Herpes zoster infections have been reported with Tecfidera use.
Slovenian: Pri uporabi zdravila Tecfidera so poročali o okužbah s herpesom zostrom.
English: No. subjects Mean (median) number of new or newly enlarging T2 lesions over 2 years Lesion mean ratio (95% CI) Mean (median) number of Gd lesions at 2 years Odds ratio (95% CI) Mean (median) number of new T1 hypointense lesions over 2 years Lesion mean ratio (95% CI) aAll analyses of clinical endpoints were intent-to-treat; bMRI analysis used MRI cohort *P-value < 0.05; **P-value < 0.01; ***P-value < 0.0001; #not statistically significant
Slovenian: aVse analize kliničnih opazovanih dogodkov so bile z namenom zdravljenja; bv analizi MRS je bila uporabljena skupina MRS *vrednost P < 0,05; **vrednost P < 0,01; ***vrednost P < 0,0001; #ni statistično značilno
English: Methacrylic acid - methyl methacrylate copolymer (1:1) Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% Simeticone
Slovenian: mikrokristalna celuloza premrežen natrijev karmelozat smukec brezvoden koloidni silicijev dioksid magnezijev stearat trietil citrat metakrilna kislina - metil metakrilat kopolimer (1:1) metakrilna kislina - etil akrilat kopolimer (1:1) disperzija 30 % simetikon natrijev lavrilsulfat polisorbat 80
English: Severe active gastrointestinal disease
Slovenian: Huda aktivna bolezen prebavil
English: If you have a serious infection (such as pneumonia), talk to your doctor immediately proteins (albumin) in urine increase in levels of liver enzymes (ALT, AST) in the blood
Slovenian: - beljakovine (albumin) v seču - zvišanje ravni jetrnih encimov (ALT, AST) v krvi
English: Leucopenia
Slovenian: Limfopenija
English: Grade 2 and 3 lymphopenia prevailed in subjects with concurrent lymphocytopenia.
Slovenian: Pri preiskovancih s sočasno limfocitopenijo je prevladovala limfopenija 2. in 3. stopnje.
English: Pharmacodynamic effects
Slovenian: Farmakodinamični učinki Učinki na imunski sistem
English: Accumulation of parent drug or monomethyl fumarate does not occur with multiple doses of dimethyl fumarate at the therapeutic regimen.
Slovenian: Pri več odmerkih dimetilfumarata pri terapevtskem režimu ne pride do kopičenje izhodne učinkovine ali monometil fumarata.
English: Administration of dimethyl fumarate at oral doses of 25, 100, and 250 mg/kg/day to pregnant rats during the period of organogenesis resulted in maternal adverse effects at 4 times the recommended dose on an AUC basis, and low fetal weight and delayed ossification (metatarsals and hindlimb phalanges) at 11 times the recommended dose on an AUC basis.
Slovenian: Dajanje dimetilfumarata v peroralnih odmerkih 25, 100 in 250 mg/kg/dan brejim podganam v obdobju organogeneze je povzročilo neželene učinke za mater pri 4-kratniku priporočenega odmerka na podlagi AUC, nizko telesno maso plodov in zapoznelo okostenitev (stopalnic in prstnic zadnjih tac) pri 11-kratniku priporočenega odmerka na podlagi AUC.
English: Flushing events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing, these events may continue to occur intermittently throughout treatment with Tecfidera.
Slovenian: Prebavni dogodki so se pojavili na začetku zdravljenja (v glavnem so se pojavili v prvem mesecu), pri čemer se lahko pri bolnikih, pri katerih se pojavijo prebavni dogodki, ti dogodki občasno pojavljajo ves čas zdravljenja z zdravilom Tecfidera.
English: In clinical trials, 34% of Tecfidera treated patients experienced flushing.
Slovenian: V kliničnih preskušanjih je 34 % bolnikov, zdravljenih z zdravilom Tecfidera, doživelo vročinsko oblivanje, pri večini bolnikov je bilo blago ali zmerno.
English: Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate
Slovenian: Ena gastrorezistentna trda kapsula vsebuje 240 mg dimetilfumarata.
English: Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules
Slovenian: Tecfidera 120 mg gastrorezistentne trde kapsule Tecfidera 240 mg gastrorezistentne trde kapsule
English: Increase of liver enzymes and cases of drug-induced liver injury (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN), have been reported in post marketing experience following Tecfidera administration, which resolved upon treatment discontinuation.
Slovenian: Po uporabi zdravila Tecfidera so pri izkušnjah v obdobju trženja poročali o zvišanju jetrnih encimov in primerih z zdravilom povzročene okvare jeter (zvišanje transaminaz na ≥ 3-kratno ULN s sočasnim zvišanjem celotnega bilirubina na > 2-kratno ULN).
English: Side effects which may show up in your blood or urine tests low levels of white blood cells (lymphopenia, leucopenia) in the blood.
Slovenian: - nizke ravni belih krvničk (limfopenija, levkopenija) v krvi.
English: Common White blood cell count decreased Common 1 Adverse reactions derived only during post marketing experience
Slovenian: 1Neželeni učinki, ugotovljeni samo pri izkušnjah iz obdobja trženja.
English: Oral administration of dimethyl fumarate at 25, 100, and 250 mg/kg/day to rats during pregnancy and lactation resulted in lower body weights in the F1 offspring, and delays in sexual maturation in F1 males at 11 times the recommended dose on an AUC basis.
Slovenian: Peroralno dajanje dimetilfumarata pri odmerku 25, 100 in 250 mg/kg/dan podganam med brejostjo in laktacijo je pri 11-kratniku priporočenega odmerka na podlagi AUC povzročilo nižjo telesno maso F1 potomcev in zapoznelo spolno zrelost F1 samcev.
English: Cases of herpes zoster have occurred with Tecfidera.
Slovenian: V povezavi z zdravilom Tecfidera so se pojavili primeri herpesa zostra.
English: The forestomach in rodents does not have a human counterpart.
Slovenian: Za predželodec pri glodavcih pri ljudeh ni ustreznega organa.
English: Nervous system disorders
Slovenian: - prebavne motnje
English: Tecfidera 120mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
Slovenian: Tecfidera 120 mg gastrorezistentne trde kapsule Ena gastrorezistentna trda kapsula vsebuje 120 mg dimetilfumarata.
English: Starting dose 120 mg twice a day.
Slovenian: 120 mg dvakrat na dan.
English: Elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN, were not observed in placebo-controlled studies.
Slovenian: Zvišanja transaminaz na ≥ 3-kratno ULN s sočasnim zvišanjem celotnega bilirubina na > 2
English: Since the renal pathway is a secondary route of elimination for dimethyl fumarate accounting for less than 16% of the dose administered, evaluation of pharmacokinetics in individuals with renal impairment was not conducted.
Slovenian: 16 % uporabljenega odmerka, ocene farmakokinetike pri posameznikih z okvaro ledvic niso izvedli.
English: Severe renal and hepatic impairment
Slovenian: Huda okvara ledvic in jeter
English: Potential risks associated with acetylsalicylic acid therapy should be considered prior to co-administration with Tecfidera in patients with Relapsing Remitting MS. Long term (> 4 weeks) continuous use of acetylsalicylic acid has not been studied (see sections 4.4 and 4.8).
Slovenian: Dolgotrajne (> 4 tednov) neprekinjene uporabe acetilsalicilne kisline niso raziskovali (glejte poglavji 4.4 in 4.8).
English: Nonclinical studies in rodent, rabbits, and monkeys were conducted with a dimethyl fumarate suspension (dimethyl fumarate in 0.8% hydroxypropyl methylcellulose) administered by oral gavage.
Slovenian: Toksikologija Z dimetilfumaratom v obliki suspenzije (dimetilfumaratom v 0,8 % hidroksipropil metilcelulozi) so izvedli predklinične študije pri glodavcih, kuncih in opicah, ki so jim suspenzijo dajali s peroralno gavažo.
English: Tecfidera 240mg gastro-resistant hard capsules
Slovenian: Tecfidera 240 mg gastrorezistentne trde kapsule
English: In the MRI cohort 36% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 1.4).
Slovenian: lezije Gd+ ob izhodišču (povprečno število lezij Gd+ 1,4).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for dimethyl fumarate (multiple sclerosis), the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za dimetilfumarat (multipla skleroza) je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke: Pri nobenem primeru niso izrecno poročali o Fanconijevem sindromu pri indikaciji multiple skleroze
English: The incidence of the adverse reactions below are expressed according to the following categories:
Slovenian: Zaradi zasnove študije je bila zelo aktivna bolezen opredeljena kot sledi:
English: Hypoxia1
Slovenian: neznana hipoksija1
English: Gastrointestinal disorders
Slovenian: - vnetje črevesne obloge (gastroenteritis)
English: Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Slovenian: Ena gastrorezistentna trda kapsula vsebuje 120 mg dimetilfumarata.
English: How to store Tecfidera
Slovenian: Shranjevanje zdravila Tecfidera
English: Effects on the immune system In preclinical and clinical studies, dimethyl fumarate demonstrated anti-inflammatory and immunomodulatory properties.
Slovenian: Dimetilfumarat je v predkliničnih in kliničnih študijah pokazal protivnetne in imunomodulacijske lastnosti.
English: Tecfidera 120 mg gastro-resistant hard capsules dimethyl fumarate
Slovenian: Tecfidera 120 mg gastrorezistentne trde kapsule dimetilfumarat
English: Tecfidera was evaluated in a prospective open-label, uncontrolled study in 22 paediatric patients with
Slovenian: Zdravilo Tecfidera so ocenili v prospektivni odprti nekontrolirani študiji pri 22 pediatričnih bolnikih z RRMS, starih od 13 do 17 let (4 bolniki so bili stari ≤14 let) .
English: Tecfidera 120mg gastro-resistant hard capsules
Slovenian: Tecfidera 120 mg gastrorezistentne trde kapsule
English: The benefit of breast-feeding for the child and the benefit of therapy for the woman should be taken into account.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Tecfidera, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Croscarmellose sodium
Slovenian: Število limfocitov
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema limfopenija pogosti levkopenija pogosti trombocitopenija občasni
English: In Study 2, patients had the following median baseline characteristics: age 37 years, disease duration 6.0 years, EDSS score 2.5.
Slovenian: V študiji 2 so imeli bolniki naslednje mediane vrednosti za izhodiščne karakteristike: starost 37 let,
English: Talk to your doctor before taking Tecfidera if you have: - severe kidney disease - severe liver disease - a disease of the stomach or bowel - a serious infection (such as pneumonia)
Slovenian: - hudo bolezen ledvic, - hudo bolezen jeter, - bolezen želodca ali črevesja,
English: Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Slovenian: Tecfidera 240 mg gastrorezistentne trde kapsule dimetilfumarat
English: These may affect up to 1 in 10 people: - inflammation of the lining of the intestines (gastroenteritis) - being sick (vomiting) - indigestion (dyspepsia) - inflammation of the lining of the stomach (gastritis) - gastrointestinal disorder - burning sensation - hot flush, feeling hot - itchy skin (pruritus) - rash - pink or red blotches on the skin (erythema)
Slovenian: - pekoč občutek - vročinski oblivi, občutek vročine - srbeča koža (pruritus) - izpuščaj - rožnate ali rdeče lise na koži (eritem)
English: You should inform your doctor immediately if you suspect you have any symptoms of shingles.
Slovenian: Če sumite, da imate kakršne koli simptome pasovca, o tem takoj obvestite zdravnika.
English: Renal tubular hyperplasia was observed in rats with life time dosing (2-year study).
Slovenian: Pri podganah so pri vseživljenjskem dajanju opazili hiperplazijo ledvičnih tubulov
English: Dyspnoea1
Slovenian: neznana dispneja1
English: Package leaflet: Information for the patient Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Slovenian: Tecfidera 120 mg gastrorezistentne trde kapsule Tecfidera 240 mg gastrorezistentne trde kapsule dimetilfumarat (dimethylis fumaras)
English: Tecfidera 240mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate For the full list of excipients, see section 6.1.
Slovenian: Tecfidera 240 mg gastrorezistentne trde kapsule Ena gastrorezistentna trda kapsula vsebuje 240 mg dimetilfumarata.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS HEAT SEALED BLISTER CARD
Slovenian: Splošne težave in spremembe na mestu aplikacije občutek vročine pogosti
English: In the MRI cohort 45% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 2.4).
Slovenian: lezije Gd+ ob izhodišču (povprečno število lezij Gd+ 2,4).
English: Progressive Multifocal Leukoencephalopathy (PML)
Slovenian: Progresivna multifokalna levkoencefalopatija (PML) V primeru zmerne do hude dolgotrajne limfopenije so se pri uporabi dimetilfumarata in drugih zdravil,
English: Dimethyl fumarate is not quantifiable in plasma following oral administration of Tecfidera.
Slovenian: Po peroralni uporabi zdravila Tecfidera dimetilfumarata v plazmi ni mogoče določiti.
English: Gelatin
Slovenian: ČET
English: Hepatic impairment
Slovenian: Klinični opazovani dogodkia
English: Sat.
Slovenian: odmerka.
English: Capsule shell
Slovenian: Delovanje jeter
English: There was no case explicitly reporting Fanconi syndrome in the Multiple Sclerosis (MS) indication; however, it has been reported in literature that that female patients with psoriasis treated long-term with fumaric acid esters seem to be at particular risk.
Slovenian: (MS), vendar pa literatura navaja, da so bolnice s psoriazo, ki se dolgotrajno zdravijo z estri fumarne kisline, izpostavljene izrazitejšemu tveganju.
English: Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.
Slovenian: V 1 mesecu je treba ponovno preiti na priporočeni vzdrževalni odmerek
English: Pregnancy and breast-feeding
Slovenian: - bruhanje - slaba prebava (dispepsija)
English: Key elements to be included in the educational material:
Slovenian: Ključni elementi, ki morajo biti vključeni v izobraževalnem gradivu:
English: • Acute coronary syndrome (including myocardial infarction) within the last 30 days
Slovenian: • Akutni koronarni sindrom (vključno z miokardnim infarktom) v zadnjih 30 dneh.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da so vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, opisani spodaj, implementirani:
English: The number of vials of BRINAVESS concentrate required to prepare the appropriate quantity of solution for the treatment of an individual patient will depend on the patient's weight, and the vial size.
Slovenian: Število vial s koncentratom zdravila BRINAVESS, potrebnih za pripravo ustrezne količine raztopine za zdravljenje posameznega bolnika, je odvisno od mase bolnika in velikosti viale.
English: Appropriate measures to manage and minimize the risks, including the need for close monitoring during and after administration of BRINAVESS.
Slovenian: Ustrezni ukrepi za obvladovanje in zmanjševanje tveganja, vključno s potrebo po natančnem nadzorovanju med uporabo zdravila BRINAVESS in po njej.
English: Patient selection criteria, including contraindications, special warnings and precautions for use and information about patient populations with limited information from clinical trials.
Slovenian: Kriteriji za izbiro bolnika, vključno s kontraindikacijami, posebnimi opozorili in previdnostnimi ukrepi ter podatki o populacijah bolnikov, za katere je na voljo malo podatkov iz kliničnih študij.
English: The Marketing Authorisation Holder shall ensure that all Healthcare Professionals (HCP) involved in the administration of BRINAVESS are provided with a healthcare professional information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da vsi zdravstveni delavci, vključeni pri uporabi zdravila BRINAVESS, dobijo paket z informacijami za zdravstveno osebje, ki vsebuje naslednje:
English: Educational material for Healthcare Professionals Summary of Product Characteristics, Package Leaflet and Labelling
Slovenian: Izobraževalno gradivo za zdravstveno osebje Povzetek glavnih značilnosti zdravila, navodilo za uporabo, ovojnina
English: • Patients with severe aortic stenosis, patients with systolic blood pressure <100 mm Hg, and patients with heart failure class NYHA III and NYHA IV.
Slovenian: • Bolniki s hudo aortno stenozo, bolniki s sistoličnim krvnim tlakom < 100 mm Hg in bolniki s srčnim popuščanjem v razredu NYHA III ali NYHA IV.
English: Risk of atrial flutter may be increased in patients receiving class I AADs.
Slovenian: Tveganje za atrijsko undulacijo je lahko pri bolnikih, ki prejemajo antiaritmike skupine I, povečano.
English: BRINAVESS may be available in different vial sizes [available vial sizes to be inserted locally].
Slovenian: Zdravilo BRINAVESS je lahko na voljo v vialah različnih velikosti [velikosti vial, ki so na voljo, vstavi država članica].
English: Only a well-qualified healthcare professional should administer BRINAVESS and should frequently monitor the patient for the duration of the infusion and for at least 15 minutes after the completion of the infusion for signs and symptoms of a sudden decrease in blood pressure or heart rate (see section 4.4).
Slovenian: Zdravilo BRINAVESS lahko da samo dobro usposobljeno zdravstveno osebje, ki mora pri bolniku med infundiranjem in še vsaj 15 minut po zaključku infundiranja pogosto preveriti, če ima znake in simptome nenadnega znižanja krvnega tlaka ali srčne frekvence (glejte poglavje 4.4).
English: Instructions on dose calculation, preparation of the solution for infusion, and method of administration.
Slovenian: Navodila za izračun odmerka, pripravo raztopine za infundiranje in način uporabe.
English: BRINAVESS should be administered by intravenous infusion in a monitored clinical setting appropriate for cardioversion.
Slovenian: Zdravilo BRINAVESS je treba dati v intravenski infuziji v okolju, primernem za kardioverzijo.
English: - Alert HCP on BRINAVESS contraindications:
Slovenian: - Opozorilo za zdravstveno osebje glede kontraindikacij za zdravilo BRINAVESS:
English: - Alert HCP about BRINAVESS special warnings and precautions in patients with, clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis, previously documented LVEF ≤ 35%, advanced hepatic impairment.
Slovenian: - Opozorilo za zdravstveno osebje glede posebnih opozoril in previdnostnih ukrepov za zdravilo BRINAVESS pri bolnikih s klinično pomembno stenozo zaklopk, hipertrofično obstruktivno kardiomiopatijo, restriktivno kardiomiopatijo ali konstriktivnim perikarditisom, predhodno dokumentiranim iztisnim deležem levega prekata (LVEF) ≤ 35 %, z napredovalo okvaro jeter.
English: • Resumption or initiation of oral-maintenance antiarrhythmic therapy can be considered 2 hours after BRINAVESS administration.
Slovenian: • Ponoven začetek ali uvedba peroralnega vzdrževalnega antiaritmičnega zdravljenja pride v poštev 2 uri po uporabi zdravila BRINAVESS.
English: • Patients with prolonged QT at baseline (uncorrected > 440 msec), or severe bradycardia, sinus node dysfunction or second degree and third degree heart block in the absence of a pacemaker.
Slovenian: • Bolniki z izhodiščnim podaljšanjem QT (nekorigirani QT > 440 msec) ali s hudo bradikardijo, disfunkcijo sinusnega vozla ali srčnim blokom 2. ali 3. stopnje brez srčnega spodbujevalnika.
English: - Alert HCP about the need of precautions when using BRINAVESS in haemodynamically stable patients with congestive heart failure NYHA I and NYHA II and the need to monitor patients with valvular heart disease closely.
Slovenian: - Opozorilo za zdravstveno osebje, da je pri uporabi zdravila BRINAVESS pri hemodinamsko stabilnih bolnikih s kongestivnim srčnim popuščanjem v razredih NYHA I in II potrebna previdnost ter da je treba bolnike z boleznijo srčnih zaklopk natančno nadzorovati.
English: • Use of intravenous rhythm control anti-arrhythmics (class I and class III) within 4 hours prior, as well as in the first 4 hours after, to BRINAVESS administration.
Slovenian: • Uporaba intravenskih antiaritmikov za kontrolo srčnega ritma (skupine I in III) v 4 urah pred uporabo in prve 4 ure po uporabi zdravila BRINAVESS.
English: • BRINAVESS should be used with caution in patients on oral AADs (class I and III), due to limited experience.
Slovenian: • Zdravilo BRINAVESS je treba pri bolnikih, ki prejemajo peroralne antiaritmike (skupine I in III), zaradi pomanjkanja izkušenj uporabljati previdno.
English: • BRINAVESS can not be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant, due to lack of data.
Slovenian: • Zdravila BRINAVESS zaradi pomanjkanja podatkov ne moremo priporočiti za bolnike, ki so 4-24 ur pred vernakalantom prejeli intravenski antiaritmik (skupine I in III).
English: - Alert HCP for use of AADs (anti-arrhythmic drugs) prior to or after BRINAVESS.
Slovenian: - Opozorilo za zdravstveno osebje glede uporabe antiaritmikov pred uporabo zdravila BRINAVESS in po njej.