FrancophonIA/ELRC3.0 huggingface dataset:
English: However, in humans, no such effect has been observed even after repeat administration at the daily dose of 10 mg.
Slovenian: Ne glede na to pa ti učinki pri človeku niso bili opaženi niti po ponavljajočem se jemanju 10-miligramskih dnevnih odmerkov.
English: Single doses up to 200 mg have been used in women without safety concern.
Slovenian: Enkratne odmerke do 200 mg so prejemale ženske brez zdravstvenih težav.
English: There is more information about contraception at the end of this leaflet.
Slovenian: Več informacij o kontracepciji je na voljo na koncu tega navodila za uporabo.
English: Some medicines may prevent ellaOne from working effectively.
Slovenian: Nekatera zdravila lahko preprečijo, da zdravilo ellaOne deluje učinkovito.
English: In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of ellaOne (73 women enrolled twice and 9 enrolled three times).
Slovenian: V študiji III. faze je 82 žensk sodelovalo več kot enkrat in je zato prejelo več kot en odmerek zdravila ellaOne (73 žensk se je v študijo vključilo dvakrat in 9 žensk trikrat).
English: If ovulation has already occurred, it is no longer effective.
Slovenian: Če je ovulacija že nastopila, zdravilo ni več učinkovito.
English: This medicine will not affect your future fertility.
Slovenian: To zdravilo ne bo vplivalo na vašo plodnost v prihodnosti.
English: The patient should be informed not to drive or use machines if they are experiencing such symptoms (see section 4.8).
Slovenian: Uporabnico je treba obvestiti, da ne sme voziti ali upravljati strojev, če opazi takšne simptome (glejte razdelek 4.8).
English: - You can take the tablet at any time of the day either before, during or after a meal.
Slovenian: - Tableto lahko vzamete kadar koli čez dan, pred ali med obrokom ali po njem.
English: Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: 1 tablet.
Slovenian: 1 tableta
English: 1: Brache et al, Contraception 2013 §: defined as presence of unruptured dominant follicle five days after late follicular-phase treatment *: compared to levonorgestrel
Slovenian: 1: Brache et al, Contraception 2013 §: opredeljena kot prisotnost nerazpočenega dominantnega folikla pet dni po jemanju zdravila v pozni folikularni fazi *: v primerjavi z levonorgestrelom
English: Among the women who received ellaOne in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.
Slovenian: Od vseh žensk, ki so prejemale zdravilo ellaOne v študiji III. faze, jih je le 0,4 % poročalo o močni krvavitvi v času med dvema menstruacijama.
English: There is some evidence that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.
Slovenian: Obstaja nekaj dokazov, da se lahko učinkovitost tega zdravila zmanjša s povečano telesno maso ali indeksom telesne mase (ITM), vendar so ti podatki omejeni in nedokončni.
English: In a majority of cases (88.2%), this bleeding was reported as spotting.
Slovenian: V večini primerov (88,2 %) je bila krvavitev zelo šibka.
English: - If you are using one of the medicines that may prevent ellaOne from working properly (see section 2 “What you need to know before you take ellaOne”) or if you have used one of these medicines in the past 4 weeks, ellaOne may work less effectively for you.
Slovenian: - Če uporabljate eno od zdravil, ki lahko prepreči pravilno delovanje zdravila ellaOne (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo ellaOne«) ali če ste uporabili eno od teh zdravil v zadnjih 4 tednih, lahko zdravilo ellaOne pri vas deluje manj učinkovito.
English: Sharing your information may help women in the future understand the safety or risks of ellaOne during a pregnancy.
Slovenian: S sporočanjem podatkov lahko pomagate ženskam v prihodnosti razumeti varnost ali tveganja, povezana z uporabo zdravila ellaOne med nosečnostjo.
English: Randomised controlled trial
Slovenian: Randomizirano kontrolirano preskušanje
English: Ulipristal acetate is not a substrate for either OATP1B1 or OATP1B3.
Slovenian: Ulipristalacetat ni substrat za OATP1B1 ali OATP1B3.
English: LABORATOIRE HRA PHARMA
Slovenian: Malta Laboratoire HRA Pharma
English: Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if a woman has stopped taking an enzyme inducer in the past 4 weeks.
Slovenian: Indukcija encimov pojema postopoma, učinki na plazemske koncentracije ulipristalacetata pa se lahko pojavijo, tudi če je ženska prenehala jemati induktor encimov v preteklih 4 tednih.
English: Carcinogenicity studies (in rats and mice) showed that ulipristal acetate is not carcinogenic.
Slovenian: Študije kancerogenosti (na podganah in miših) so pokazale, da ulipristalacetat ni kancerogen.
English: As a result, this medicine works by postponing ovulation.
Slovenian: To zdravilo torej deluje tako, da odloži ovulacijo.
English: After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected.
Slovenian: Po zaužitju tablete lahko menstruacija včasih nastopi nekaj dni prej ali pozneje od predvidenega datuma.
English: This is because the sperm can survive up to 5 days in your body after intercourse.
Slovenian: Semenčice lahko namreč preživijo v vašem telesu tudi do 5 dni po spolnem odnosu.
English: 59452 Lys-Lez-Lannoy France
Slovenian: 59452 Lys-Lez-Lannoy
English: The delay was greater than 20 days in 4 % of the women.
Slovenian: Ta zamuda je bila pri 4 % žensk večja od 20 dni.
English: ellaOne tablet
Slovenian: ellaOne tableta
English: 92320 CHATILLON France
Slovenian: 92320 CHATILLON
English: As with any pregnancy, the possibility of an ectopic pregnancy should be considered.
Slovenian: Kot pri vsaki nosečnosti je treba upoštevati možnost zunajmaternične nosečnosti.
English: A post-marketing observational study evaluating efficacy and safety of ellaOne in adolescents aged 17 and younger showed no difference in the safety and efficacy profile compared to adult women aged 18 and older.
Slovenian: Opazovalna študija v obdobju trženja, v kateri so ocenili učinkovitost in varnost zdravila ellaOne pri mladostnicah, starih 17 let in mlajših, ni pokazala razlik v profilu varnosti in učinkovitosti v primerjavi z odraslimi ženskami, starimi 18 let in več.
English: When the data from the two trials were combined via meta- analysis, the risk of pregnancy with ulipristal acetate was significantly reduced compared to levonorgestrel (p=0.046).
Slovenian: Ko so primerjali podatke iz obeh preskušanj z meta-analizo se je izkazalo, da je bila rizičnost nosečnosti pri uporabi ulipristalacetata signifikantno znižana v primerjavi z uporabo levonorgestrela (p=0,046).
English: The effect of breast-feeding your baby in the week after taking this medicine is not known.
Slovenian: Učinek dojenja v tednu po uporabi tega zdravila ni znan.
English: If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register your pregnancy in an official registry.
Slovenian: Če zanosite kljub uporabi zdravila ellaOne, prosite zdravnika, naj zapiše vašo nosečnost v uradni register.
English: It has minimal affinity to the androgen receptor and no affinity for the human estrogen or mineralocorticoid receptors.
Slovenian: Ima minimalno afiniteto za androgenski receptor in nobene afinitete za estrogenske ali mineralokortikoidne receptorje pri človeku.
English: If you have taken emergency contraception and you do not use a regular contraceptive method (or do not have a contraceptive method that suits you), talk to your doctor or family planning clinic for advice.
Slovenian: Če ste vzeli nujno kontracepcijo in ne uporabljate redne kontracepcijske metode (ali nimate kontracepcijske metode, ki bi vam ustrezala), se posvetujte s svojim zdravnikom ali kliniko za načrtovanje družine.
English: It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy.
Slovenian: Pomembno je vedeti, da pojav krvavitve iz maternice ne izključuje zunajmaternične nosečnosti.
English: Information from reproductive toxicity studies is limited due to the absence of exposure measurement in these studies.
Slovenian: Podatki iz študij vpliva na sposobnost razmnoževanja so omejeni zaradi pomanjkanja meritev izpostavljenosti v teh študijah.
English: Nevertheless it is important that any pregnancy in a woman who has taken ellaOne be reported to www.hra-pregnancy-registry.com.
Slovenian: Kljub temu pa je pomembno poročati o vsaki nosečnosti pri ženski, ki je vzela zdravilo ellaOne, na spletnem mestu www.hra-pregnancyregistry.com.
English: BMI (kg/m2)
Slovenian: ITM (kg/m2)
English: Vaginal Ring
Slovenian: Vaginalni obroček
English: At doses which were low enough to maintain gestation in the animal species, no teratogenic effects were observed.
Slovenian: Pri odmerkih za živali, ki so bili dovolj majhni, da so dopuščali gestacijo, niso opazili teratogenih učinkov.
English: If you have used any of the medicines listed below during the last 4 weeks, ellaOne may be less suitable for you.
Slovenian: Če ste v zadnjih 4 tednih uporabili katero od spodaj naštetih zdravil, je zdravilo ellaOne morda manj primerno za vas.
English: Ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg) and in monkeys.
Slovenian: Ulipristalacetat ima letalni učinek na zarodek pri podganah, kuncih (pri ponavljajočih se odmerkih, ki presegajo 1 mg/kg) in opicah.
English: By taking them both together, you might make this medicine less effective.
Slovenian: Sočasna uporaba lahko povzroči, da bo to zdravilo manj učinkovito.
English: The purpose of this web-based registry is to collect safety information from women who have taken ellaOne during pregnancy or who become pregnant after ellaOne intake.
Slovenian: Namen tega spletnega registra je zbiranje podatkov o varnosti pri ženskah, ki so vzele zdravilo ellaOne med nosečnostjo ali ki zanosijo po zaužitju zdravila ellaOne.
English: This medicine is suitable for any woman of childbearing age, including adolescents.
Slovenian: To zdravilo je primerno za vse ženske v rodni dobi, vključno z mladostnicami.
English: Therefore, ellaOne is still recommended for all women regardless of their weight or BMI.
Slovenian: Zdravilo ellaOne se zato še vedno priporoča pri vseh ženskah, ne glede na telesno maso ali ITM.
English: Pregnancy rate 0.00% 1.23% 1.29% 2.57%
Slovenian: Delež nosečnosti 0,00 % 1,23 % 1,29 % 2,57 % Interval zaupanja 0,00-2,84
English: Odds ratio [95% CI] of pregnancy risk, ulipristal acetate vs levonorgestrel2
Slovenian: Kvocient tveganja [95% CI] za nosečnosti, ulipristalacetat versus levonorgestrel2
English: MORE ABOUT REGULAR CONTRACEPTION
Slovenian: VEČ O REDNI KONTRACEPCIJI
English: Use in women with severe asthma treated by oral glucocorticoid is not recommended.
Slovenian: Uporabe pri ženskah s hudo astmo, ki se zdravijo s peroralnimi glukokortikoidi, se ne priporoča.
English: In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected.
Slovenian: Pri približno 7% žensk se je menstruacijski ciklus začel več kot 7 dni pred predvidenim datumom.
English: The timing of ovulation cannot be predicted and therefore the tablet should be taken as soon as possible after unprotected intercourse.
Slovenian: Časa ovulacije ni mogoče predvideti, zato je treba vzeti tableto čim prej po nezaščitenem spolnem odnosu.
English: Post-marketing experience: the adverse reactions spontaneously reported in post-marketing experience were similar in nature and frequency to the safety profile described during the phase III program.
Slovenian: Izkušnje v obdobju trženja: neželeni učinki, o katerih so ženske spontano poročale v obdobju trženja, so bili po naravi in pogostnosti podobni varnostnemu profilu, opisanemu med III. fazo programa.
English: If you do not have a regular method of contraception, talk to your doctor or healthcare professional to choose one that is suitable for you.
Slovenian: Če nimate redne kontracepcijske metode, se posvetujte s svojim zdravnikom ali drugim zdravstvenim delavcem in izberite eno, ki je primerna za vas.
English: Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see section 4.2).
Slovenian: Mladostnice: varnostni profil pri ženskah, starih manj kot 18 let, v študijah in v obdobju trženja, je podoben varnostnemu profilu pri odraslih v III. fazi programa (glejte poglavje 4.2).
English: Special populations Renal impairment
Slovenian: Posebne populacije Okvara ledvic
English: Such high doses were well-tolerated; however, these women had a shortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and in some women, the duration of bleeding was prolonged, although not excessive in amount (spotting).
Slovenian: Tako visoke odmerke so dobro prenesle; vendar pa so poročale o skrajšanem menstruacijskem ciklusu (do menstrualne krvavitve je prišlo 2-3 dni bolj zgodaj kot je bilo pričakovano), pri nekaterih ženskah pa je bilo tudi trajanje krvavitve podaljšano, ni pa bila krvavitev bolj obilna (šibka krvavitev).
English: E-mail: info-ella@hra-pharma.com
Slovenian: E-pošta: info-ella@hra-pharma.com
English: In any case, women should be advised to adopt a regular method of contraception.
Slovenian: Ženskam je treba v vsakem primeru svetovati uporabo redne kontracepcije.
English: Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a Cu-IUD.
Slovenian: Vaš zdravnik vam lahko predpiše drugo vrsto (nehormonske) nujne kontracepcije, tj. Cu-IUD.
English: Most findings in general toxicity studies were related to its mechanism of action as a modulator of progesterone and glucocorticoid receptors, with antiprogesterone activity observed at exposures similar to therapeutic levels.
Slovenian: Večina ugotovitev iz splošnih študij toksičnosti se je nanašala na mehanizem delovanja kot modulator progesteronskih in glukokortikoidnih receptorjev, pri čemer je bilo antiprogesteronsko delovanje opaženo pri izpostavljenosti, podobni terapevtskim odmerkom.
English: Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines.
Slovenian: Obvestite farmacevta, zdravnika ali drugega zdravstvenega delavca, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, vključno z zdravili, ki so na voljo brez recepta, ali zdravili rastlinskega izvora.
English: It should in no instance replace a regular contraceptive method.
Slovenian: V nobenem primeru ne sme nadomestiti redne kontracepcije.
English: Limited human data regarding pregnancy exposure to ellaOne do not suggest any safety concern.
Slovenian: Omejeni podatki, pridobljeni pri ljudeh glede izpostavljenosti zdravilu ellaOne med nosečnostjo, ne kažejo nobenih varnostnih zadržkov.
English: Emergency contraception will not affect your fertility.
Slovenian: Nujna kontracepcija ne bo vplivala na vašo plodnost.
English: The majority of women (74.6%) in the phase III studies had their next menstrual period at the expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses.
Slovenian: Večina žensk (74,6 %) je v študiji III. faze dobila naslednjo menstruacijo ob predvidenem času ali v obdobju ± 7 dni, 6,8 % žensk je dobilo menstruacijo več kot 7 dni pred predvidenim datumom, pri 18,5 % pa je menstruacija zamujala več kot 7 dni po predvidenem datumu.
English: Although no teratogenic potential has been observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Slovenian: Čeprav niso opazili nobenega teratogenega potenciala, študije na živalih niso zadostne za oceno vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Emergency contraception does not protect against sexually transmitted infections
Slovenian: Nujna kontracepcija ne ščiti pred spolno prenosljivimi okužbami.
English: If you have used certain other medicines in the last 4 weeks, in particular for epilepsy, tuberculosis, HIV infection or herbal medicines containing St. John´s wort (see leaflet), ellaOne may work less effectively.
Slovenian: Če ste v zadnjih 4 tednih jemali določena druga zdravila, zlasti za zdravljenje epilepsije, tuberkuloze, za zdravljenje okužbe z virusom HIV ali zdravila rastlinskega izvora, ki vsebujejo šentjanževko (glejte navodilo), je lahko zdravilo ellaOne manj učinkovito.
English: If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy.
Slovenian: Če zanosite kljub uporabi tega zdravila, ni dokazov, da bo zdravilo vplivalo na nosečnost.
English: If vomiting occurs within 3 hours of the tablet intake, another tablet should be taken.
Slovenian: Če se v 3 urah po zaužitju tablete pojavi bruhanje, je treba vzeti še eno tableto.
English: After taking this medicine, some women experience dizziness, drowsiness, blurred vision and/or loss of concentration (see section 4).
Slovenian: Po uporabi tega zdravila se pri nekaterih ženskah pojavijo omotica, zaspanost, zamegljen vid in/ali poslabšanje koncentracije (glejte poglavje 4).
English: ellaOne does not work if you are already pregnant.
Slovenian: Zdravilo ellaOne ne deluje, če ste že noseči.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Ženske z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Influenza
Slovenian: - gripa
English: USEFUL INFORMATION ABOUT CONTRACEPTION MORE ABOUT EMERGENCY CONTRACEPTION
Slovenian: UPORABNE INFORMACIJE O KONTRACEPCIJI VEČ O NUJNI KONTRACEPCIJI
English: This is especially important if you have severe abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside the womb, tubal surgery or long term (chronic) genital infection.
Slovenian: To je še posebej pomembno, če imate hude bolečine v trebuhu ali krvavitev ali če ste v preteklosti že imeli zunajmaternično nosečnost, operacijo jajcevodov ali dolgotrajno (kronično) okužbo spolovil.
English: Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting), feeling sick (nausea) are also possible signs of pregnancy.
Slovenian: Nekateri simptomi, kot so občutljive dojke in bolečine v trebuhu, bruhanje, slabost s siljenjem na bruhanje (navzea), so tudi možni znaki nosečnosti.
English: After taking the tablet, it is normal for your next period to be a few days late.
Slovenian: Po jemanju tablete je normalno, če naslednja menstruacija nastopi nekaj dni prepozno.
English: In the absence of specific studies, ulipristal acetate is not recommended.
Slovenian: Zaradi pomanjkanja specifičnih študij se uporaba ulipristalacetata ne priporoča.
English: When used for emergency contraception the mechanism of action is inhibition or delay of ovulation via suppression of the luteinising hormone (LH) surge.
Slovenian: Kadar se uporablja za nujno kontracepcijo, je mehanizem delovanja zaviranje ali odlaganje ovulacije, ki poteka prek zaviranja zvišanja ravni luteinizirajočega hormona (LH).
English: Emergency contraception can delay ovulation within a given menstrual cycle, but it will not stop you from becoming pregnant if you have unprotected sex again.
Slovenian: Nujna kontracepcija lahko odloži ovulacijo v danem menstrualnem ciklusu, vendar ne bo preprečila zanositve, če boste ponovno imeli nezaščiten spolni odnos.
English: During this time it is recommended to express and discard the breast milk in order to stimulate lactation.
Slovenian: V tem času je priporočljivo materino mleko iztisniti in zavreči, da se tako stimulira laktacija.
English: If you are already pregnant it will not interrupt an existing pregnancy.
Slovenian: Če ste že noseči, ne bo prekinilo obstoječe nosečnosti.
English: Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any of the medicines stated above.
Slovenian: Pogovorite se s svojim zdravnikom ali farmacevtom preden uporabite zdravilo ellaOne, če uporabljate (ali ste pred kratkim uporabljali) katero izmed zgoraj naštetih zdravil.
English: P-glycoprotein (P-gp) substrates
Slovenian: Substrati P-glikoproteina (P-gp)
English: Similar results were obtained for the active mono-demethylated metabolite.
Slovenian: Podobni rezultati so bili pridobljeni tudi za aktivni monodemetilirani presnovek.
English: Adverse reactions listed below are classified according to frequency and system organ class 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 <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Spodaj našteti neželeni učinki so razvrščeni glede na pogostnost in organske sisteme v naslednji obliki: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Potential for ulipristal acetate to affect other medicinal products
Slovenian: Možnost vpliva ulipristalacetata na druga zdravila
English: For the full list of excipients, see section 6.1
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Excipients with known effect Each tablet contains 237 mg of lactose (as monohydrate).
Slovenian: Pomožne snovi z znanim učinkom Ena tableta vsebuje 237 mg laktoze (monohidrat).
English: As for any pregnancy, your doctor may want to check that the pregnancy is not outside the womb.
Slovenian: Kot pri vsaki nosečnosti bo zdravnik morda želel preveriti, ali je nosečnost zunajmaternična.
English: In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed.
Slovenian: Če naslednja menstruacija zamuja več kot 7 dni, če je menstruacija nenormalnega značaja, če se pojavijo simptomi, ki kažejo na nosečnost, ali v primeru dvoma je treba opraviti test nosečnosti.
English: Although the use of ulipristal acetate for emergency contraception does not contraindicate the continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (see section 4.5).
Slovenian: Čeprav uporaba ulipristalacetata za nujno kontracepcijo ne kontraindicira nadaljnje uporabe redne hormonske kontracepcije, lahko zdravilo ellaOne zmanjša njeno kontracepcijsko delovanje (glejte poglavje 4.5).
English: A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days.
Slovenian: Pri manjšemu deležu žensk (8,7 %) se je v času med dvema menstruacijama pojavila krvavitev, ki je trajala povprečno 2,4 dneva.
English: In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations.
Slovenian: Podatki in vitro kažejo, da ulipristalacetat in njegov aktivni presnovek v klinično pomembnih koncentracijah nista pomembna zaviralca encimov CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 in 3A4.
English: The mono-demethylated metabolite is pharmacologically active.
Slovenian: Monodemetiliran presnovek je farmakološko aktiven.
English: If you take more ellaOne than you should
Slovenian: Če ste vzeli večji odmerek zdravila ellaOne, kot bi smeli
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Normal
Slovenian: Normalen