FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Bexsero in children up to 10 years of age (seen in more than 1 patient in 10) are eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, arthralgia (joint pain), fever and irritability as well as tenderness, swelling, hardness and redness of the skin at the injection site.
Slovenian: Najpogostejši neželeni učinki zdravila Bexsero pri otrocih, starih do deset let (opaženi pri več kot 1 od 10 bolnikov), so motnje hranjena, zaspanost, neobičajen jok, glavobol, driska, bruhanje, izpuščaj, artralgija (bolečine v sklepih), povišana telesna temperatura in razdražljivost ter občutljivost, oteklina, zatrdlina in pordelost kože na mestu injiciranja.
English: Bexsero is a vaccine used to protect individuals from the age of two months against invasive meningococcal disease caused by one group of the bacterium Neisseria meningitidis (group B).
Slovenian: Zdravilo Bexsero je cepivo, ki se uporablja za zaščito oseb, starih vsaj dva meseca, pred invazivno meningokokno boleznijo, ki jo povzroča bakterija Neisseria meningitidis (skupina B).
English: The most common side effects with Bexsero in adolescents from 11 years of age and adults (seen in more than 1 patient in 10) are headache, nausea (feeling sick) and malaise (feeling unwell), myalgia (muscle pain) and arthralgia as well as pain, swelling, hardness and redness of the skin at the injection site.
Slovenian: Najpogostejši neželeni učinki zdravila Bexsero pri mladostnikih, starejših od 11 let, in odraslih (opaženi pri več kot 1 od 10 bolnikov) so glavobol, navzea (siljenje na bruhanje), slabo počutje, mialgija (bolečine v mišicah) in artralgija (bolečine v sklepih) ter bolečina, oteklina, zatrdlina in pordelost kože na mestu injiciranja.
English: For the full list of side effects and restrictions with Bexsero, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Bexsero glejte navodilo za uporabo.
English: Bexsero contains parts of the bacteria N. meningitidis group B.
Slovenian: Zdravilo Bexsero vsebuje dele bakterije N. meningitidis skupine B.
English: The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. In addition, a single booster dose of Bexsero at 12 months of age produced a stronger immune response in children who had already received Bexsero than the first of two ‘catchup' doses in children of the same age who had not.
Slovenian: Študija je pokazala, da je zdravilo Bexsero učinkovito pri spodbujanju imunskega odziva proti bakteriji N. meningitidis skupine B. Študija je tudi pokazala, da je enkratni poživitveni odmerek zdravila Bexsero pri starosti 12 mesecev povzročil močnejši imunski odziv pri otrocih, ki so zdravilo Bexsero že prejeli, kot prvi od dveh naknadnih odmerkov pri otrocih iste starosti, ki zdravila prej niso prejeli.
English: This study was extended to look at the effects of giving a booster dose of Bexsero at or after 12 months of age to children who had already received Bexsero in early infancy, compared with giving two ‘catch-up' doses to those who had not.
Slovenian: Študija je bila razširjena tako, da so v njej proučevali učinke dajanja poživitvenega odmerka zdravila Bexsero otrokom, ki so to cepivo že prejeli kot dojenčki, pri starosti 12 mesecev ali po dopolnjenih 12 mesecih v primerjavi z dajanjem dveh naknadnih odmerkov otrokom, ki cepiva prej niso prejeli.
English: Two main studies showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. The studies measured the production of protective antibodies which are able to kill the bacteria.
Slovenian: Dve glavni študiji sta pokazali, da je zdravilo Bexsero učinkovito pri spodbujanju imunskega odziva proti bakteriji N. meningitidis skupine B. V študijah so merili tvorbo zaščitnih protiteles, ki lahko uničijo bakterije.
English: How does Bexsero work?
Slovenian: Kako zdravilo Bexsero deluje?
English: How is Bexsero used?
Slovenian: Kako se zdravilo Bexsero uporablja?
English: The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B and that two doses were needed to produce an adequate immune response.
Slovenian: Študija je pokazala, da je zdravilo Bexsero učinkovito pri spodbujanju imunskega odziva proti bakteriji N. meningitidis skupine B in da sta za ustrezen imunski odziv potrebna dva odmerka.
English: Bexsero has been shown to produce a robust immune response to N. meningitidis group B and the risks are acceptable.
Slovenian: Za zdravilo Bexsero je bilo dokazano, da spodbuja izrazit imunski odziv proti bakteriji N. meningitidis skupine B in da so tveganja sprejemljiva.
English: Bexsero contains four proteins which are found on the surfaces of cells of the N. meningitidis group B bacterium.
Slovenian: Zdravilo Bexsero vsebuje štiri beljakovine, ki so prisotne na površini celic bakterije N. meningitidis skupine B. Cepivo je „adsorbirano“.
English: This summary was last updated in 06-2018.
Slovenian: Povzetek je bil nazadnje posodobljen 06-2018.
English: Most patients had previously received other medicines but could not continue with them.
Slovenian: Večina bolnikov je pred tem prejemala druga zdravila, vendar zdravljenja ni mogla nadaljevati.
English: Further information on Xagrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Xagrid so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In the other three studies, between 60 and 82% of patients had a complete response.
Slovenian: V drugih treh študijah je bilo mogoče popoln odziv zaznati pri med 60 in 82 % bolnikov.
English: Xagrid (anagrelide) EMA/326376/2018
Slovenian: Xagrid (anagrelid) EMA/326376/2018
English: Patients were treated with Xagrid for up to five years.
Slovenian: Bolniki so se z zdravilom Xagrid zdravili do pet let.
English: Xagrid (anagrelide)
Slovenian: Xagrid (anagrelid)
English: What measures are being taken to ensure the safe and effective use of Xagrid?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xagrid?
English: The European Medicines Agency decided that Xagrid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Xagrid večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: Xagrid was not compared with any other medicines.
Slovenian: Zdravila Xagrid niso primerjali z nobenim drugim zdravilom.
English: Xagrid is available as capsules (0.5 mg).
Slovenian: Zdravilo Xagrid je na voljo v obliki kapsul (0,5 mg).
English: In the largest study, 67% of the patients with essential thrombocythaemia (628 out of 934), and 66% of those who could not tolerate other treatments or whose condition did not respond to them (480 out of 725) had a complete response to Xagrid.
Slovenian: V najobsežnejši študiji je bil pri 67 % (628 od 934) bolnikov z esencialno trombocitemijo in pri 66 % (480 od 725) tistih, ki drugih zdravljenj niso mogli prenašati ali katerih zdravstveno stanje se nanje ni odzvalo, odziv na zdravilo Xagrid popoln.
English: Treatment should only be started by a doctor who has experience in the treatment of essential thrombocythaemia.
Slovenian: Zdravljenje sme uvesti samo zdravnik, ki ima izkušnje z zdravljenjem esencialne trombocitemije.
English: Xagrid received a marketing authorisation valid throughout the EU on 16 November 2004.
Slovenian: Za zdravilo Xagrid je bilo 16. novembra 2004 izdano dovoljenje za promet, veljavno po vsej EU.
English: Xagrid was originally authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Xagrid je pridobilo prvotno dovoljenje za promet v „izjemnih okoliščinah“.
English: The most common side effect with Xagrid (which may affect more than 1 in 10 people) is headache.
Slovenian: Najpogostejši neželeni učinek zdravila Xagrid (ki se lahko pojavi pri več kot 1 od 10 bolnikov) je glavobol.
English: As for all medicines, data on the use of Xagrid are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xagrid stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xagrid have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xagrid upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The main measure of effectiveness was the number of patients who had a ‘complete response', when platelet counts fell either by at least 50% from the start of treatment or to below 600 million/ml.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bil „odziv popoln“, ko se je število krvnih ploščic zmanjšalo za najmanj 50 % od začetka zdravljenja oziroma pod 600 milijonov na mililiter.
English: Other information about Xagrid
Slovenian: Druge informacije o zdravilu Xagrid
English: The maximum recommended dose of Xagrid is 5 capsules at a time.
Slovenian: Največji priporočeni odmerek zdravila Xagrid je pet kapsul naenkrat.
English: An overview of Xagrid and why it is authorised in the EU
Slovenian: Pregled zdravila Xagrid in zakaj je odobreno v EU
English: The dose can then be increased every week by 1 capsule a day, until the patient's platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the usual level in healthy people).
Slovenian: Priporočeni začetni odmerek je ena kapsula dvakrat na dan. Odmerek se lahko nato povečuje vsak teden za eno kapsulo na dan, dokler število krvnih ploščic pri bolniku ne doseže vrednosti pod 600 milijonov na mililiter, v najboljšem primeru pa med 150 in 400 milijoni na mililiter (raven, ki je običajna pri zdravih ljudeh).
English: Xagrid must not be used in patients with moderate or severe liver or kidney disease.
Slovenian: Zdravila Xagrid ne smejo uporabljati bolniki z zmernimi ali hudimi jetrnimi ali ledvičnimi obolenji.
English: Side effects reported with Xagrid are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Xagrid, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: This is because, as a result of the disease's rarity, it had not been possible to obtain full information about it. As the company has supplied the additional information requested, the ‘exceptional circumstances' ended on 11.07.2018.
Slovenian: Ker je podjetje predložilo zahtevane dodatne podatke, so izjemne okoliščine prenehale veljati 11.07.2018.
English: For more information about using Xagrid, see the package leaflet or contact a doctor or a pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Xagrid glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Xagrid have been shown in studies?
Slovenian: Kakšne koristi zdravila Xagrid so se pokazale v študijah?
English: Why is Xagrid authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Xagrid odobreno v EU?
English: Xagrid was effective in lowering platelet counts in four main studies involving patients with various diseases in which the bone marrow produces too many cells.
Slovenian: Zdravilo Xagrid je bilo učinkovito pri zniževanju števila krvnih ploščic v štirih glavnih študijah, v katere so bili vključeni bolniki z različnimi boleznimi, pri katerih kostni mozeg proizvaja preveč celic.
English: What are the risks associated with Xagrid?
Slovenian: Kakšna tveganja so povezana z zdravilom Xagrid?
English: Xagrid is used when patients do not respond to or do not tolerate their current treatment, and when they are ‘at risk' because of their age (over 60 years), very high platelet counts or previous clotting problems.
Slovenian: Zdravilo Xagrid se uporablja pri bolnikih, ki se ne odzivajo na trenutno zdravljenje ali ga ne prenašajo, ter pri bolnikih, pri katerih obstaja tveganje zaradi starosti (nad 60 let), zelo velikega števila krvnih ploščic ali predhodnih težav s strjevanjem krvi.
English: What is Xagrid and what is it used for?
Slovenian: Kaj je zdravilo Xagrid in za kaj se uporablja?
English: The active substance in Xagrid, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes', which produce platelets.
Slovenian: Učinkovina v zdravilu Xagrid, anagrelid, zavira razvoj in rast celic kostnega mozga, imenovanih „megakariociti“, ki proizvajajo krvne ploščice.
English: Almost 3,000 of the patients in the studies had essential thrombocythaemia, with a platelet count of more than 600 million/ml.
Slovenian: Skoraj 3 000 bolnikov v študijah je imelo esencialno trombocitemijo s številom krvnih ploščic, večjim od 600 milijonov na mililiter.
English: Xagrid is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets in the blood).
Slovenian: Zdravilo Xagrid se uporablja za zmanjšanje števila krvnih ploščic (sestavine v krvi, ki sodeluje pri strjevanju krvi) pri bolnikih z esencialno trombocitemijo (boleznijo, pri kateri je v krvnem obtoku preveč krvnih ploščic).
English: For the full list of all side effects of Xagrid, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Xagrid glejte navodilo za uporabo.
English: In essential thrombocythaemia the bone marrow produces too many platelets.
Slovenian: Pri esencialni trombocitemiji kostni mozeg proizvaja preveč krvnih ploščic.
English: Xagrid contains the active substance anagrelide.
Slovenian: Zdravilo Xagrid vsebuje učinkovino anagrelid.
English: How is Xagrid used?
Slovenian: Kako se zdravilo Xagrid uporablja?
English: Xagrid can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Xagrid je le na recept.
English: How does Xagrid work?
Slovenian: Kako zdravilo Xagrid deluje?
English: The median age was 54 years.
Slovenian: Mediana starost je bila 54 let.
English: A risk to the newborn/infant cannot be excluded.
Slovenian: Tveganja za novorojenca/otroka ne moremo izključiti.
English: Talk to your doctor about the right methods of contraception for you and your partner.
Slovenian: Z zdravnikom se posvetujte o pravih načinih kontracepcije za vas in vašega partnerja.
English: ● and is advanced.
Slovenian: ● in je napredoval.
English: Sensitivity to sunlight
Slovenian: Občutljivost za sončno svetlobo
English: ● The other ingredients are:
Slovenian: ● Druge sestavine zdravila so:
English: Frequency category (all grades)
Slovenian: Kategorija pogostnosti (vse stopnje)
English: Contraception, pregnancy, and breast-feeding - information for women Contraception - information for women
Slovenian: Kontracepcija, nosečnost in dojenje - informacije za ženske Kontracepcija - informacije za ženske
English: Effects of age, body weight, race and gender
Slovenian: Vplivi starosti, telesne mase, rase in spola
English: The majority of these events occurred during the first 3 months of treatment.
Slovenian: Večina teh dogodkov se je pojavila v prvih 3 mesecih zdravljenja.
English: Heart rate and blood pressure should be monitored as clinically indicated.
Slovenian: Srčno frekvenco in krvni tlak je treba kontrolirati, kot je klinično indicirano.
English: The corresponding values for M4 were 217 L/hour and 30.7 hours, respectively.
Slovenian: Ustrezni vrednosti za M4 sta 217 l/uro in 30,7 ure.
English: They must be taken with food (see section 5.2).
Slovenian: Vzeti jih mora s hrano (glejte poglavje 5.2).
English: Within each system organ class, undesirable effects are presented in order of decreasing frequency.
Slovenian: Znotraj posameznega organskega sistema so neželeni učinki navedeni po padajoči pogostnosti.
English: Patients who experience overdose should be closely supervised and general supportive care instituted.
Slovenian: Bolnike, pri katerih pride do prevelikega odmerjanja, je treba skrbno kontrolirati in jim uvesti splošno podporno oskrbo.
English: Dose modification advice is provided in Tables 1 and 2 below.
Slovenian: Smernice za prilagoditev odmerka so prikazane spodaj v preglednicah 1 in 2.
English: ● is ‘ALK-positive' - this means your cancer cells have a fault in a gene that makes an enzyme called
Slovenian: ● je "ALK-pozitiven" - to pomeni, da imajo rakave celice napako v genu, ki proizvaja encim,
English: ● You must take Alecensa with food.
Slovenian: ● Zdravilo Alecensa morate vzeti s hrano.
English: Duration of treatment Treatment with Alecensa should be continued until disease progression or unacceptable toxicity.
Slovenian: Trajanje zdravljenja Zdravljenje z zdravilom Alecensa je treba nadaljevati do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
English: M4 is a substrate of P-gp.
Slovenian: M4 je substrat P-gp.
English: Patients should not take two doses at the same time to make up for a missed dose.
Slovenian: Bolniki ne smejo vzeti dveh odmerkov hkrati, da bi nadomestili izpuščeni odmerek.
English: It is important to take Alecensa twice a day for as long as your doctor prescribes it for you.
Slovenian: Pomembno je, da zdravilo Alecensa jemljete dvakrat na dan toliko časa, kot vam je predpisal zdravnik.
English: Alecensa with food and drink
Slovenian: Zdravilo Alecensa skupaj s hrano in pijačo
English: Abnormal forms of this enzyme (due to fault in the gene that makes it) help encourage cancer cell growth.
Slovenian: Nenormalne oblike tega encima (zaradi napake v genu, ki ga zapisuje) prispevajo k spodbujanju rasti rakavih celic.
English: ● if you are allergic to alectinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: ● če ste alergični na alektinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Thereafter, monitoring should be performed periodically, since events may occur later than 3 months, with more frequent testing in patients who develop aminotransferase and bilirubin elevations.
Slovenian: Kasneje je treba spremljanje izvajati periodično, ker se dogodki lahko pojavijo po več kot 3 mesecih; pri bolnikih, ki se jim pojavi zvišanje aminotransferaz in bilirubina, morajo biti kontrole pogostejše.
English: Extreme body weight (>130 kg)
Slovenian: Močno prekomerna telesna masa (> 130 kg)
English: The majority of patients had no history of smoking (62%).
Slovenian: Večina bolnikov ni imela anamneze kajenja (62 %).
English: ● you may feel tired, weak or short of breath due to a reduction in the number of red blood cells,
Slovenian: ● občutek utrujenosti, šibkosti ali zadihanosti zaradi zmanjšanega števila rdečih krvnih celic
English: This is equivalent to 2.4% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 2,4 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: ● Do not throw away any medicines via wastewater or household waste.
Slovenian: ● Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: NE [NE; NE]
Slovenian: [NO; NO]
English: Primary efficacy parameter
Slovenian: Primarni parameter učinkovitosti
English: Do not open or dissolve the capsules.
Slovenian: Kapsul ne odpirajte in jih ne raztapljajte.
English: Treatment with Alecensa should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z zdravilom Alecensa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: N = 35 [6.9, NE]
Slovenian: n = 35 [6,9; NO]
English: The hard capsules should be swallowed whole, and must not be opened or dissolved.
Slovenian: Trde kapsule mora bolnik pogoltniti cele in jih ne sme odpirati ali raztapljati.
English: Grade 4 (life-threatening consequences, urgent intervention indicated)
Slovenian: Bradikardijaa stopnje 4 (življenjsko ogrožujoče posledice, potrebno je nujno ukrepanje)
English: The majority of patients had no history of smoking (70%).
Slovenian: Večina bolnikov ni imela anamneze kajenja (70 %).
English: Date of latest renewal: 1 December 2017
Slovenian: Datum prve odobritve: 16. februar 2017 Datum zadnjega podaljšanja: 1. december 2017
English: Tell your doctor straight away if you notice any of the following side effects.
Slovenian: Zdravnika takoj obvestite, če opazite katerega od naslednjih neželenih učinkov.
English: The events generally occurred during the first 3 months of treatment, were usually transient and the majority resolved upon dose modification.
Slovenian: Ti učinki so se običajno pojavili v prvih 3 mesecih zdravljenja, po navadi so bili prehodni in večina jih je po prilagoditvi odmerka izzvenela.
English: There are no available data on patients over 80 years of age.
Slovenian: starejše od 80 let, podatkov ni na voljo.
English: The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity), and not a clastogenic effect on chromosomes.
Slovenian: Mehanizem indukcije mikrojeder je bila nenormalna segregacija kromosomov (anevgenost), in ne klastogeni učinek na kromosome.
English: This includes medicines obtained without a prescription, and herbal medicines.
Slovenian: To velja tudi za zdravila, ki ste jih dobili brez recepta, in za zdravila rastlinskega izvora.
English: The ADRs listed in Table 3 are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Slovenian: Neželeni učinki, navedeni v preglednici 3, so prikazani po organskih sistemih in skupinah pogostnosti upoštevaje naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: Median duration of follow-up (months)
Slovenian: Mediano trajanje spremljanja (meseci)
English: Aluminium/aluminium (PA/Alu/PVC/Alu) blisters containing 8 hard capsules.
Slovenian: Aluminijsko/aluminijski (PA/Alu/PVC/Alu) pretisni omoti, ki vsebujejo 8 trdih kapsul.
English: Swallow each capsule whole.
Slovenian: Vsako kapsulo pogoltnite celo.
English: Patients should be advised to report any unexplained muscle pain, tenderness, or weakness.
Slovenian: Bolnikom je treba naročiti, naj poročajo o vseh nepojasnjenih mišičnih bolečinah, občutljivosti ali šibkosti.
English: The geometric mean of the individual elimination half-life estimates for alectinib was 32.5 hours.
Slovenian: Geometrična sredina individualnih ocen eliminacijskega razpolovnega časa za alektinib je 32,5 ure.
English: Secondary efficacy parameters
Slovenian: Sekundarni parametri učinkovitosti
English: multiple sclerosis)
Slovenian: (npr. multiple skleroze),
English: What you need to know before you take Alecensa 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Alecensa 3.
English: The capsules are also available in plastic bottles containing 240 hard capsules.
Slovenian: Kapsule so na voljo tudi v plastenkah, ki vsebujejo 240 trdih kapsul.
English: Take the medicine pack and this leaflet with you.
Slovenian: S seboj vzemite ovojnino zdravila in to navodilo za uporabo.
English: ● severe muscle pain, tenderness, and weakness (myalgia).
Slovenian: ● huda mišična bolečina, občutljivost in šibkost (mialgija).
English: Alecensa has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Alecensa ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: A lower confidence limit for the estimated ORR above the pre-specified threshold of 35% would achieve a statistically significant result.
Slovenian: Za doseganje statistično značilnega rezultata bi morala biti spodnja meja zaupanja ocenjenega ORR višja od vnaprej določene mejne vrednosti 35 %.