natgillin/translations-raw huggingface dataset:
Oral administration of dimethyl fumarate to female rats at 25, 100, and 250 mg/kg/day prior to and during mating, and continuing to Day 7 of gestation, induced reduction in the number of estrous stages per 14 days and increased the number of animals with prolonged diestrus at the highest dose tested (11 times the recommended dose on an AUC basis). 
Peroralno dajanje dimetilfumarata podganjim samicam v odmerkih 25, 100 in 250 mg/kg/dan pred parjenjem in med njim ter nadaljevanje do 7. dne brejosti je povzročilo zmanjšanje števila estrusnih stopenj na 14 dni in zvišanje števila živali s podaljšanjem diestrusa pri najvišjem testiranem odmerku (11-kratnik priporočenega odmerka na osnovi AUC).
Contents of the pack and other information 
Shranjevanje zdravila Tecfidera Vsebina pakiranja in dodatne informacije
Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys. 
Po ponavljajočem se peroralnem dajanju dimetilfumarata mišim, podganam, psom in opicam so opazili spremembe na ledvicah.
In the majority of patients who experienced flushing, it was mild or moderate in severity. 
Pri večini bolnikov, pri katerih so se prebavni dogodki pojavljali, so bili blagi ali zmerni.
Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided within an hour of taking Tecfidera, as alcohol may lead to increased frequency of gastrointestinal adverse reactions. 
se je treba eno uro pred jemanjem in eno uro po jemanju zdravila Tecfidera izogibati, ker alkohol lahko zviša pogostnost neželenih učinkov na prebavila.
The apparent volume of distribution following oral administration of 240 mg dimethyl fumarate varies between 60 L and 90 L. Human plasma protein binding of monomethyl fumarate generally ranges between 27% and 40%. 
Porazdelitev Navidezni volumen porazdelitve po peroralni uporabi 240 mg dimetilfumarata je med 60 l in 90 l.
Patients should be instructed to discontinue Tecfidera and seek immediate medical care if they experience signs or symptoms of anaphylaxis. 
Bolnike je treba poučiti, naj v primeru pojava znakov ali simptomov anafilaksije prenehajo jemati zdravilo Tecfidera in poiščejo takojšnjo medicinsko pomoč.
Data from preclinical studies do not suggest that dimethyl fumarate would be associated with an increased risk of reduced fertility (see section 5.3). 
da bi bil dimetilfumarat povezan s povečanim tveganjem za zmanjšano plodnost (glejte poglavje 5.3).
In the testes, degeneration of the seminiferous epithelium was seen in rats and dogs. 
V modih so pri podganah in psih ugotovili degeneracijo seminifernega epitelija.
The benefit/risk in patients with lymphocyte counts ≥0.5 x 109/L and <0.8 x 109/L for more than six months should be assessed. 
Pri bolnikih, pri katerih je število limfocitov več kot šest mesecev ≥ 0,5 x 109/l in < 0,8 x 109/l, je treba oceniti razmerje med koristjo in tveganjem.
Tecfidera 240 mg: Each capsule contains 240 mg of dimethyl fumarate. 
Tecfidera 240 mg: ena kapsula vsebuje 240 mg dimetilfumarata.
If you forget or miss a dose, do not take a double dose. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Oral administration of dimethyl fumarate at 25, 75, and 150 mg/kg/day to pregnant rabbits during organogenesis had no effect on embryo-fetal development and resulted in reduced maternal body weight at 7 times the recommended dose and increased abortion at 16 times the recommended dose, on an AUC basis. 
Peroralno dajanje dimetilfumarata pri odmerkih 25, 75 in 150 mg/kg/dan brejim kunčicam med organogenezo ni vplivalo na razvoj zarodka/ploda in je pri 7-kratniku priporočenega odmerka na podlagi AUC povzročilo zmanjšanje telesne mase kunčice in pri 16-kratniku priporočenega odmerka na podlagi AUC povečanje abortusov.
Levels of 1,25-dihydroxyvitamin D decreased in Tecfidera treated patients relative to placebo (median percentage decrease from baseline at 2 years of 25% versus 15%, respectively) and levels of parathyroid hormone (PTH) increased in Tecfidera treated patients relative to placebo (median percentage increase from baseline at 2 years of 29% versus 15%, respectively). 
2 letih 25 % v primerjavi s 15 %), ravni paratiroidnega hormona (PTH) pa so se pri bolnikih, zdravljenih z zdravilom Tecfidera, v primerjavi z bolniki, ki so prejemali placebo, zvišale (mediana odstotka zvišanja od izhodišča pri 2 letih 29 % v primerjavi s 15 %).
Tecfidera 120 mg: Each capsule contains 120 mg of dimethyl fumarate. 
Tecfidera 120 mg: ena kapsula vsebuje 120 mg dimetilfumarata.
The active substance is dimethyl fumarate. 
Učinkovina je dimetilfumarat.
Consumption of more than a small quantity (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, e.g. spirits) should be avoided within an hour of taking Tecfidera, as alcohol can interact with this medicine. 
Zaužitju močnih alkoholnih pijač (več kot 30 vol. % alkohola, npr. žganja) v količinah, ki niso majhne
Dimethyl fumarate exposure increases in an approximately dose proportional manner with single and multiple doses in the 120 mg to 360 mg dose range studied. 
Linearnost Pri preučevanih enkratnih in večkratnih odmerkih razpona odmerka 120 mg in 360 mg se izpostavljenost dimetilfumaratu veča približno sorazmerno z odmerkom.
If JCV testing is undertaken, it should be considered that the influence of lymphopenia on the accuracy of anti-JCV antibody test has not been studied in dimethyl fumarate treated patients. 
zdravljenih z dimetilfumaratom, vpliv limfopenije na točnost testa za določanje protiteles proti virusu JC ni raziskan.
14 gastro-resistant hard capsules 
14 gastrorezistentnih trdih kapsul
- liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin) 
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - vnetje jeter in zvišanje ravni jetrnih encimov (ALT ali AST v kombinaciji z bilirubinom)
Cases of anaphylaxis/anaphylactoid reaction have been reported following Tecfidera administration in the post-marketing setting. 
V obdobju trženja zdravila so poročali o primerih anafilaksije/anafilaktoidne reakcije po uporabi zdravila Tecfidera.
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. 
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.
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). 
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).
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). 
Sočasno zdravljenje z nefrotoksičnimi zdravili (kot so aminoglikozidi, diuretiki, nesteroidna protivnetna zdravila ali litij) lahko poveča možnost neželenih učinkov na ledvice (npr. proteinurija,
These may affect up to 1 in 100 people: - Allergic reactions (hypersensitivity) - reduction in blood platelets 
- alergijske reakcije (preobčutljivost) - zmanjšanje števila trombocitov
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. 
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.
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. 
Simptomi lahko vključujejo novo nastalo ali poslabšano oslabelost ene strani telesa, okornost, spremembe vida,
Herpes zoster infections have been reported with Tecfidera use. 
Pri uporabi zdravila Tecfidera so poročali o okužbah s herpesom zostrom.
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 
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
Methacrylic acid - methyl methacrylate copolymer (1:1) Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% Simeticone 
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
Severe active gastrointestinal disease 
Huda aktivna bolezen prebavil
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 
- beljakovine (albumin) v seču - zvišanje ravni jetrnih encimov (ALT, AST) v krvi
Grade 2 and 3 lymphopenia prevailed in subjects with concurrent lymphocytopenia. 
Pri preiskovancih s sočasno limfocitopenijo je prevladovala limfopenija 2. in 3. stopnje.
Pharmacodynamic effects 
Farmakodinamični učinki Učinki na imunski sistem
Accumulation of parent drug or monomethyl fumarate does not occur with multiple doses of dimethyl fumarate at the therapeutic regimen. 
Pri več odmerkih dimetilfumarata pri terapevtskem režimu ne pride do kopičenje izhodne učinkovine ali monometil fumarata.
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. 
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.
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. 
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.
In clinical trials, 34% of Tecfidera treated patients experienced flushing. 
V kliničnih preskušanjih je 34 % bolnikov, zdravljenih z zdravilom Tecfidera, doživelo vročinsko oblivanje, pri večini bolnikov je bilo blago ali zmerno.
Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate 
Ena gastrorezistentna trda kapsula vsebuje 240 mg dimetilfumarata.
Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules 
Tecfidera 120 mg gastrorezistentne trde kapsule Tecfidera 240 mg gastrorezistentne trde kapsule
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. 
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).
Side effects which may show up in your blood or urine tests low levels of white blood cells (lymphopenia, leucopenia) in the blood. 
- nizke ravni belih krvničk (limfopenija, levkopenija) v krvi.
Common White blood cell count decreased Common 1 Adverse reactions derived only during post marketing experience 
1Neželeni učinki, ugotovljeni samo pri izkušnjah iz obdobja trženja.
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. 
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.
Cases of herpes zoster have occurred with Tecfidera. 
V povezavi z zdravilom Tecfidera so se pojavili primeri herpesa zostra.
The forestomach in rodents does not have a human counterpart. 
Za predželodec pri glodavcih pri ljudeh ni ustreznega organa.
Nervous system disorders 
- prebavne motnje
Tecfidera 120mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate. 
Tecfidera 120 mg gastrorezistentne trde kapsule Ena gastrorezistentna trda kapsula vsebuje 120 mg dimetilfumarata.
Starting dose 120 mg twice a day. 
120 mg dvakrat na dan.
Elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN, were not observed in placebo-controlled studies. 
Zvišanja transaminaz na ≥ 3-kratno ULN s sočasnim zvišanjem celotnega bilirubina na > 2
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. 
16 % uporabljenega odmerka, ocene farmakokinetike pri posameznikih z okvaro ledvic niso izvedli.
Severe renal and hepatic impairment 
Huda okvara ledvic in jeter
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). 
Dolgotrajne (> 4 tednov) neprekinjene uporabe acetilsalicilne kisline niso raziskovali (glejte poglavji 4.4 in 4.8).
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. 
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.
Tecfidera 240mg gastro-resistant hard capsules 
Tecfidera 240 mg gastrorezistentne trde kapsule
In the MRI cohort 36% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 1.4). 
lezije Gd+ ob izhodišču (povprečno število lezij Gd+ 1,4).
Taking into account the PRAC Assessment Report on the PSUR(s) for dimethyl fumarate (multiple sclerosis), the scientific conclusions of CHMP are as follows: 
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
The incidence of the adverse reactions below are expressed according to the following categories: 
Zaradi zasnove študije je bila zelo aktivna bolezen opredeljena kot sledi:
Hypoxia1 
neznana hipoksija1
Gastrointestinal disorders 
- vnetje črevesne obloge (gastroenteritis)
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate 
Ena gastrorezistentna trda kapsula vsebuje 120 mg dimetilfumarata.
How to store Tecfidera 
Shranjevanje zdravila Tecfidera
Effects on the immune system In preclinical and clinical studies, dimethyl fumarate demonstrated anti-inflammatory and immunomodulatory properties. 
Dimetilfumarat je v predkliničnih in kliničnih študijah pokazal protivnetne in imunomodulacijske lastnosti.
Tecfidera 120 mg gastro-resistant hard capsules dimethyl fumarate 
Tecfidera 120 mg gastrorezistentne trde kapsule dimetilfumarat
Tecfidera was evaluated in a prospective open-label, uncontrolled study in 22 paediatric patients with 
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) .
Tecfidera 120mg gastro-resistant hard capsules 
Tecfidera 120 mg gastrorezistentne trde kapsule
The benefit of breast-feeding for the child and the benefit of therapy for the woman should be taken into account. 
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.
Croscarmellose sodium 
Število limfocitov
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema limfopenija pogosti levkopenija pogosti trombocitopenija občasni
In Study 2, patients had the following median baseline characteristics: age 37 years, disease duration 6.0 years, EDSS score 2.5. 
V študiji 2 so imeli bolniki naslednje mediane vrednosti za izhodiščne karakteristike: starost 37 let,
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) 
- hudo bolezen ledvic, - hudo bolezen jeter, - bolezen želodca ali črevesja,
Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate 
Tecfidera 240 mg gastrorezistentne trde kapsule dimetilfumarat
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) 
- pekoč občutek - vročinski oblivi, občutek vročine - srbeča koža (pruritus) - izpuščaj - rožnate ali rdeče lise na koži (eritem)
You should inform your doctor immediately if you suspect you have any symptoms of shingles. 
Če sumite, da imate kakršne koli simptome pasovca, o tem takoj obvestite zdravnika.
Renal tubular hyperplasia was observed in rats with life time dosing (2-year study). 
Pri podganah so pri vseživljenjskem dajanju opazili hiperplazijo ledvičnih tubulov
Dyspnoea1 
neznana dispneja1
Package leaflet: Information for the patient Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate 
Tecfidera 120 mg gastrorezistentne trde kapsule Tecfidera 240 mg gastrorezistentne trde kapsule dimetilfumarat (dimethylis fumaras)
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. 
Tecfidera 240 mg gastrorezistentne trde kapsule Ena gastrorezistentna trda kapsula vsebuje 240 mg dimetilfumarata.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS HEAT SEALED BLISTER CARD 
Splošne težave in spremembe na mestu aplikacije občutek vročine pogosti
In the MRI cohort 45% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 2.4). 
lezije Gd+ ob izhodišču (povprečno število lezij Gd+ 2,4).
Progressive Multifocal Leukoencephalopathy (PML) 
Progresivna multifokalna levkoencefalopatija (PML) V primeru zmerne do hude dolgotrajne limfopenije so se pri uporabi dimetilfumarata in drugih zdravil,
Dimethyl fumarate is not quantifiable in plasma following oral administration of Tecfidera. 
Po peroralni uporabi zdravila Tecfidera dimetilfumarata v plazmi ni mogoče določiti.
Gelatin 
ČET
Hepatic impairment 
Klinični opazovani dogodkia
Sat. 
odmerka.
Capsule shell 
Delovanje jeter
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. 
(MS), vendar pa literatura navaja, da so bolnice s psoriazo, ki se dolgotrajno zdravijo z estri fumarne kisline, izpostavljene izrazitejšemu tveganju.
Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed. 
V 1 mesecu je treba ponovno preiti na priporočeni vzdrževalni odmerek
Pregnancy and breast-feeding 
- bruhanje - slaba prebava (dispepsija)
Key elements to be included in the educational material: 
Ključni elementi, ki morajo biti vključeni v izobraževalnem gradivu:
• Acute coronary syndrome (including myocardial infarction) within the last 30 days 
• Akutni koronarni sindrom (vključno z miokardnim infarktom) v zadnjih 30 dneh.
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: 
Države članice morajo zagotoviti, da so vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, opisani spodaj, implementirani:
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. 
Število vial s koncentratom zdravila BRINAVESS, potrebnih za pripravo ustrezne količine raztopine za zdravljenje posameznega bolnika, je odvisno od mase bolnika in velikosti viale.
Appropriate measures to manage and minimize the risks, including the need for close monitoring during and after administration of BRINAVESS. 
Ustrezni ukrepi za obvladovanje in zmanjševanje tveganja, vključno s potrebo po natančnem nadzorovanju med uporabo zdravila BRINAVESS in po njej.
Patient selection criteria, including contraindications, special warnings and precautions for use and information about patient populations with limited information from clinical trials. 
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.
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: 
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:
Educational material for Healthcare Professionals Summary of Product Characteristics, Package Leaflet and Labelling 
Izobraževalno gradivo za zdravstveno osebje Povzetek glavnih značilnosti zdravila, navodilo za uporabo, ovojnina
• Patients with severe aortic stenosis, patients with systolic blood pressure <100 mm Hg, and patients with heart failure class NYHA III and NYHA IV. 
• 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.