FrancophonIA/ELRC3.0 huggingface dataset:
English: •Obligation to conduct post-authorisation measures
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
English: Before starting treatment with Daliresp, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Slovenian: Pred začetkom zdravljenja z zdravilom Daliresp obvestite zdravnika, če imate kakršne koli simptome te vrste ali, če morebiti jemljete še dodatna zdravila, ker lahko katero od teh poveča verjetnost teh neželenih učinkov.
English: • Copies of the patient card to be given to patients or caregivers before they receive Daliresp
Slovenian: • Kopije opozorilne kartice za bolnika, ki naj bi jih bolniki ali skrbniki prejeli pred začetkom jemanja zdravila Daliresp
English: The educational pack should contain the following: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp
Slovenian: Izobraževalno gradivo mora vsebovati naslednje: • Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila Daliresp
English: The need to inform patients about the risks of Daliresp and the precautions for safe use including:
Slovenian: Obveznost informiranja bolnikov o tveganjih zdravila Daliresp in previdnostnih ukrepih za varno uporabo vključujoč:
English: Daliresp is to be used in addition to bronchodilators.
Slovenian: Zdravilo Daliresp se uporablja poleg bronhodilatatorjev.
English: Thus Daliresp eases breathing problems.
Slovenian: Tako zdravilo Daliresp olajša težave z dihanjem.
English: Daliresp has been studied in clinical trials for up to one year.
Slovenian: Klinične študije z zdravilom Daliresp so trajale do enega leta.
English: Other medicines and Daliresp
Slovenian: Druga zdravila in zdravilo Daliresp
English: The fact that Daliresp is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.
Slovenian: Dejstvo, da zdravilo Daliresp ni indicirano za zdravljenje bolnikov s KOPB izven odobrene indikacije, niti ni primerno za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
English: Daliresp should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Slovenian: Zdravila Daliresp se ne sme uvesti oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
English: Hypromellose Macrogol 4000 Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: Obloga hipromeloza makrogol 4000 titanov dioksid (E171) rumeni železov oksid (E172)
English: The potential risk of infections: Dalirespshould not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Slovenian: Potencialno tveganje za okužbe: zdravila Dalirespse ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
English: All patients should be informed about the risks of Daliresp and the precautions for safe use and should be given a patient card before starting Daliresp.
Slovenian: Vse bolnike je treba obvestiti o tveganjih zdravila Daliresp in previdnostnih ukrepih za varno uporabo in jim je treba dati kartico za bolnike pred začetkom jemanja zdravila.
English: In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomized and treated of whom 2,374 were treated with roflumilast.
Slovenian: V dve potrditveni ponovljeni enoletni študiji (M2-124 in M2-125) in dve dodatni šestmesečni študiji (M2-127 in M2-128) je bilo randomiziranih skupno 4.768 bolnikov, od tega jih je bilo 2.374 zdravljenih z roflumilasom.
English: Daliresp is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Slovenian: Zdravilo Daliresp ni namenjeno zdravljenju nenadnih napadov težkega dihanja (akutni bronhospazmi).
English: The effect of Daliresp may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy).
Slovenian: Učinek zdravila Daliresp se lahko zmanjša, če istočasno jemljete rifampicin (antibiotik) ali fenobarbital, karbamazepin ali fenitoin (zdravila, ki so običajno predpisana za zdravljenje epilepsije).
English: 1 What Daliresp is and what it is used for
Slovenian: Kaj je zdravilo Daliresp in za kaj ga uporabljamo
English: The potential cardiac risk: Daliresphas not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Slovenian: Potencialno tveganje za srce: zdravilo Daliresp ni bilo raziskano pri bolnikih s kongestivnim srčnim popuščanjem (NYHA stopnje 3 in 4); za to populacijo ni priporočljiv.
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide.
Slovenian: Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Daliresp in potencialno tveganje za samomor.
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daliresp are provided with an updated Educational pack.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli vsi zdravniki, ki bodo predpisovali zdravilo Daliresp, na razpolago posodobljeno izobraževalno gradivo.
English: 2 What you need to know before you take Daliresp
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Daliresp
English: Daliresp 500 micrograms
Slovenian: Daliresp 500 mikrogramov
English: There is no relevant use of Daliresp in the paediatric population (under 18 years) in the indication COPD.
Slovenian: Uporaba zdravila Daliresp za indikacijo KOPB pri pediatrični populaciji (mlajših od 18 let) ni primerna.
English: If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure.
Slovenian: Če ste vzeli večji odmerek zdravila Daliresp, kot bi smeli Če ste vzeli več tablet kot bi smeli, se lahko pojavijo naslednji simptomi: glavobol, slabost, driska, omotica, udarjanje srca, vrtoglavica, vlažna in hladna koža ter nizek krvni tlak.
English: If you forget to take Daliresp
Slovenian: Če ste pozabili vzeti zdravilo Daliresp
English: You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daliresp may be harmful for the unborn baby.
Slovenian: Ves čas zdravljenja morate uporabljati učinkovito kontracepcijo, saj lahko zdravilo Daliresp škodljivo vpliva na nerojenega otroka.
English: The clinical data with Daliresp in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daliresp should be used with caution in these patients.
Slovenian: Klinični podatki o uporabi zdravila Daliresp pri bolnikih z blago okvaro jeter stopnje Child-Pugh A ne zadostujejo, da bi lahko priporočili prilagoditev odmerka (glejte poglavje 5.2), zato je pri teh bolnikih treba zdravilo Daliresp uporabljati previdno.
English: Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Slovenian: Zdravilo Daliresp je indicirano za vzdrževalno zdravljenje hude oblike kronične obstruktivne pljučne bolezni (KOPB) (FEV1 po bronhodilatatorju manjši od 50 % pričakovane vrednosti), povezane s kroničnim bronhitisom, pri odraslih bolnikih z anamnezo pogostih poslabšanj bolezni kot dopolnilo zdravljenju z bronhodilatatorji.
English: If you stop taking Daliresp
Slovenian: Če ste prenehali jemati zdravilo Daliresp
English: There is a lack of relevant experience with Daliresp under these conditions.
Slovenian: V takšnih primerih ni ustreznih izkušenj z uporabo zdravila Daliresp.
English: Daliresp has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Daliresp nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Daliresp is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Slovenian: Zdravilo Daliresp uporabljamo za vzdrževalno zdravljenje KOPB pri odraslih, ki so v preteklosti imeli pogosta poslabšanja simptomov KOPB in imajo kronični bronhitis.
English: Driving and using machines Daliresp has no influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Daliresp nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Daliresp tablets contain lactose.
Slovenian: Zdravilo Daliresp vsebuje laktozo.
English: What Daliresp is and what it is used for What you need to know before you take Daliresp How to take Daliresp
Slovenian: Kaj je zdravilo Daliresp in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Daliresp Kako jemati zdravilo Daliresp Možni neželeni učinki
English: Daliresp is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Slovenian: Zdravilo Daliresp je kontraindicirano pri bolnikih z zmerno ali hudo okvaro jeter (Child-Pugh B ali C).
English: Daliresp may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Slovenian: Zdravilo Daliresp lahko jemljete skupaj z drugimi zdravili za zdravljenje KOPB, kot so inhalacijski ali peroralni bronhodilatatorji.
English: Rescue medicinal products Daliresp is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Slovenian: Zdravila za prvo pomoč Zdravilo Daliresp ni indicirano kot zdravilo za prvo pomoč pri zdravljenju akutnih bronhospazmov.
English: If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended todiscontinue treatment with Daliresp.
Slovenian: Če bolniki trpijo zaradi novih ali zaradi poslabšanja psihiatričnih simptomov ali če se ugotovi pojav samomorilnih misli ali poskus samomora, je priporočljivo prekiniti zdravljenje z zdravilom Daliresp.
English: Daliresp will not help you in this situation.
Slovenian: Zdravilo Daliresp v takšnih primerih ne pomaga.
English: That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Slovenian: Da zdravilo Daliresp lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na opozorilno kartico za bolnika.
English: What Daliresp contains - The active substance is roflumilast.
Slovenian: Kaj vsebuje zdravilo Daliresp - Zdravilna učinkovina je roflumilast.
English: Daliresp contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Slovenian: Zdravilo Daliresp vsebuje zdravilno učinkovino roflumilast, ki je protivnetno zdravilo, imenovano zaviralec fosfodiesteraze 4.
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Dalirespshould not be initiated or should be stopped in these patients.
Slovenian: Pomanjkanje izkušenj pri bolnikih z okužbo HIV ali aktivnim hepatitisom, z resnimi imunološkimi boleznimi (npr. multiplo sklerozo, eritematoznim lupusom, multifokalno leukoencefalopatijo) ali na zdravljenju z imunosupresivnimi zdravili (razen kratkotrajnega zdravljenja s sistemskimi kortikosteroidi) in zdravila Dalirespse pri teh bolnikih ne sme uvajati oz. ga je treba ukiniti.
English: Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase 4 (PDE4) inhibitory activity.
Slovenian: Za obe spojini, roflumilast in roflumilast N-oksid, je značilno intrinzično inhibitorno delovanje na fosfodiesterazo 4 (PDE4).
English: In a pooled analysis of the one-year studies M2-124 and M2-125, roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 48 ml (pre-bronchodilator FEV1, primary endpoint, p<0.0001), and by 55 ml (post-bronchodilator FEV1, p<0.0001).
Slovenian: V analizi združenih podatkov iz enoletnih študij M28124 in M28125 je roflumilast 500 mikrogramov enkrat na dan pomembno izboljšal pljučno funkcijo v primerjavi s placebom, v povprečju za 48 ml (FEV1 pred bronhodilatatorjem, primarni klinični izid, p < 0,0001) in za 55 ml (FEV1 po bronhodilatatorju, p < 0,0001).
English: Daliresp is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Slovenian: Zdravilo Daliresp ni priporočljivo za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daliresp (see section 4.3).
Slovenian: Bolniki z zmerno ali hudo okvaro jeter stopnje Child-Pugh B ali C zdravila Daliresp ne smejo jemati (glejte poglavje 4.3).
English: Warnings and precautions Talk to your doctor or pharmacist before taking Daliresp
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Daliresp se posvetujte z zdravnikom ali s farmacevtom.
English: Roflumilast is not recommended in women of childbearing potential not using contraception.
Slovenian: Pri bolnicah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, uporaba zdravila roflumilasta ni priporočljiva.
English: Analysis
Slovenian: Analizni model
English: It is important to continue taking Daliresp for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Slovenian: Zaradi vzdrževanja normalnega delovanja pljuč je pomembno, da nadaljujete z jemanjem zdravila Daliresp tako dolgo, kot vam je predpisal zdravnik, tudi če nimate simptomov.
English: 3 How to take Daliresp
Slovenian: Kako jemati zdravilo Daliresp
English: Thus, roflumilast treatment is not recommended in patients receiving strong cytochrome P450 enzyme inducers.
Slovenian: Pri bolnikih, ki se zdravijo z močnimi zaviralci encima citokroma P450, uporaba zdravila roflumilasta tako ni priporočljiva.
English: How to store Daliresp
Slovenian: Shranjevanje zdravila Daliresp
English: Daliresp 500 micrograms tablets roflumilast
Slovenian: Daliresp 500 mikrogramov tablete roflumilast
English: What Daliresp looks like and contents of the pack Daliresp 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Slovenian: Daliresp 500 mikrogramov filmsko obložene tablete so rumene barve, v obliki črke D in imajo na eni strani izbočeno črko “D”.
English: (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Slovenian: Zdravljenje z zdravilom Daliresp ni priporočljivo, če imate eno ali več naslednjih bolezni: - resne bolezni imunskega sistema, kot so okužba s HIV, multipla skleroza (MS), eritematozni lupus (EL) ali progresivna multifokalna levkoencefalopatija (PML), - resne akutne infekcijske bolezni, kot sta tuberkuloza ali akutni hepatitis, - raka (razen bazalnoceličnega karcinom- počasi napredujoča oblika kožnega raka), - resno okvaro srčne funkcije.
English: Daliresp contains Lactose
Slovenian: Zdravilo Daliresp vsebuje laktozo
English: Daliresp 500 micrograms film-coated tablets Roflumilast
Slovenian: Daliresp 500 mikrogramov filmsko obložene tablete roflumilast
English: You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Daliresp.
Slovenian: V prvih tednih zdravljenja z zdravilom Daliresp boste morda imeli drisko, slabost, bolečine v trebuhu ali glavobol.
English: Daliresp 500 micrograms film-coated tablets
Slovenian: Daliresp 500 mikrogramov filmsko obložene tablete
English: Frequency System Organ Class
Slovenian: Zmanjšanje telesne mase
English: Roflumilast
Slovenian: Roflumilast in roflumilast
English: Immune system disorders
Slovenian: Organski sistemi
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') already authorised in the European Union (EU).
Slovenian: To pomeni, da je podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: It can request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Slovenian: V roku 15 dni od prejema uradnega obvestila o negativnem mnenju lahko zahteva ponovno presojo mnenja.
English: The company that applied for authorisation is Marvel Lifesciences Ltd.
Slovenian: Družba, ki je zaprosila za dovoljenje, je Marvel Lifesciences Ltd.
English: Two additional studies in patients with type 1 and type 2 diabetes compared the safety and effectiveness of Solumarv and Humulin S.
Slovenian: Dve dodatni študiji pri bolnikih s sladkorno boleznijo tipa 1 in tipa 2 sta primerjali varnost in učinkovitost zdravil Solumarv in Humulin S.
English: On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorisation for the medicinal product Solumarv, intended for the treatment of diabetes.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je 19. novembra 2015 priporočil zavrnitev dovoljenja za promet z zdravilom Solumarv, namenjenim zdravljenju sladkorne bolezni.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes affected by the Committee's opinion.
Slovenian: Družba je CHMP obvestila, da ni nobenih kliničnih preizkušanj ali programov sočutne uporabe, na katere bi lahko vplivalo mnenje odbora.
English: Diabetes is a condition in which the body does not produce enough insulin to control the level of blood sugar or in which the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen je bolezen, pri kateri telo ne tvori dovolj insulina za uravnavanje ravni sladkorja v krvi ali pri katerem telo insulina ne more učinkovito izrabiti.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 November 2015 EMA/765377/2015 EMEA/H/C/003858
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: The CHMP's main concern was that the company did not define the manufacturing process for Solumarv in sufficient detail.
Slovenian: Glavni zadržek CHMP je bil, da družba ni dovolj podrobno opredelila proizvodnega postopka za zdravilo Solumarv.
English: The company presented results of studies in healthy people designed to show that Solumarv is similar to its reference medicine Humulin S in terms of biological activity and how the body handles the medicine.
Slovenian: Družba je predstavila rezultate študij pri zdravih ljudeh, ki naj bi pokazale, da je zdravilo Solumarv podobno referenčnemu zdravilu Humulin S v smislu biološke aktivnosti in načina, na katerega telo presnavlja zdravilo.
English: It was to be available as a solution for injection.
Slovenian: Na voljo je v obliki raztopine za injiciranje.
English: Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels.
Slovenian: Zdravilo Solumarv naj bi se uporabljalo za zdravljenje bolnikov s sladkorno boleznijo, ki za nadzor ravni sladkorja v krvi potrebujejo insulin.
English: As such, it was not possible to show that Solumarv used in clinical studies was representative of batches intended for the market and that its quality was comparable to Humulin S's.
Slovenian: Tako ni bilo mogoče dokazati, da je bilo zdravilo Solumarv, ki je bilo uporabljeno v kliničnih študijah, reprezentativno za serije, namenjene za promet, in da je bila njegova kvaliteta primerljiva z zdravilom Humulin S.
English: The reference medicine for Solumarv in this application was Humulin S.
Slovenian: Referenčno zdravilo za Solumarv v tej vlogi je bilo zdravilo Humulin S.
English: Refusal of the marketing authorisation for Solumarv (insulin human) EMA/765377/2015
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Solumarv (humani insulin) EMA/861021/2015
English: The CHMP concluded that Solumarv could not be approved as a biosimilar of Humulin S and recommended that it be refused marketing authorisation.
Slovenian: CHMP je zaključil, da zdravila Solumarv ni mogoče odobriti kot biološko podobnega zdravilu Humulin S, in priporočil, da se dovoljenje za promet zavrne.
English: Refusal of the marketing authorisation for Solumarv (insulin human)
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Solumarv (humani insulin)
English: Solumarv is a medicine that contains the active substance human insulin.
Slovenian: Zdravilo Solumarv je zdravilo, ki vsebuje zdravilno učinkovino humani insulin.
English: Solumarv was intended as a replacement for the insulin made by the body.
Slovenian: Zdravilo Solumarv je bilo predvideno kot nadomestilo za insulin, ki nastaja v telesu.
English: Solumarv was developed as a biosimilar medicine.
Slovenian: Zdravilo Solumarv je biološko podobno zdravilo.
English: These differences are also expected to occur in practice;
Slovenian: Te razlike se pričakujejo tudi v praksi;
English: In this way, 13 formulation groups were established.
Slovenian: Na ta način so sestavili 13 formulacijskih skupin.
English: The numbering of the formulation groups is arbitrary.
Slovenian: Številčenje formulacijskih skupin je samovoljno.
English: Formulation Group
Slovenian: Formulacija skupina
English: Not for use in animals producing milk for human consumption.
Slovenian: Ni za uporabo pri živalih za proizvodnjo mleka za prehrano ljudi.
English: 22,23-Dihydroavermectin B1a
Slovenian: 22,23-dihidroavermektin B1a
English: No suitable data
Slovenian: Ni primernih podatkov
English: CEVA SANTE ANIMALE Str. Chindiei, nr. 5
Slovenian: Romunija CEVA SANTE ANIMALE Str. Chindiei, nr. 5
English: The individual withdrawal periods calculated by the CVMP ranged from 21 days to 78 days.
Slovenian: Posamezne karence, ki jih je izračunal CVMP, so znašale od 21 dni do 78 dni.
English: Ceva-Phylaxia Oltóanyagtermelő Zrt.
Slovenian: Madžarska Ceva-Phylaxia Oltóanyagtermelő Zrt.
English: Such an effect has been shown in experimental studies performed by a number of different groups (Lo et al., 19853; Wicks et al., 19934; Lifschitz et al. 19995, Lifschitz et al., 20046).
Slovenian: Takšen učinek je v izkustvenih študijah dokazalo več različnih skupin (Lo et al., 19853; Wicks et al., 19934; Lifschitz et al. 19995, Lifschitz et al., 20046).
English: In fact, a small and pharmacologically insignificant difference in absorbed fraction (e.g. 99.5% versus 99.9%) at a certain time point may imply a significant difference in the amount remaining in the injection site (a factor of 5 in this example).
Slovenian: Dejansko lahko manjša in farmakološko nepomembna razlika v absorbirani frakciji (npr. 99,5 % namesto 99,9 %) na določeni časovni točki povzroči pomembno razliko v količini, ki je preostala na mestu injiciranja (v tem primeru faktor 5).
English: However, the Committee considered that the use of the alternative approach (first time point below the ADI plus safety span) would insufficiently take account of the substantial amount of data (280 data points) available in this particular case.
Slovenian: Vendar je Odbor ugotovil, da z uporabo alternativnega pristopa (prva časovna točka pod ADI z dodatkom varnostnega razpona) ne bi zadostno upoštevali velike količine podatkov (280 podatkovnih točk), razpoložljivih v tem primeru.