FrancophonIA/ELRC3.0 huggingface dataset:
English: The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) (see section 4.2 and section 4.4) through the fistula tracts and use of local anaesthesia is not recommended due to the unknown effect on the injected cells (see section 4.4).
Slovenian: Injiciranje katere koli druge snovi, razen 0,9-odstotne raztopine natrijevega klorida (9 mg/ml), (npr. vodikovega peroksida, metilenskega modrila, raztopin joda ali hipertoničnih raztopin glukoze) (glejte poglavje 4.2 ter poglavje 4.4) v traktih fistule in uporaba lokalne anestezije nista priporočljiva, ker učinek na injicirane celice ni znan (glejte poglavje 4.4).
English: The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) (see section 4.2 and section 4.5) through the fistula tracts is not allowed before, during, or after the injection of Alofisel as these may compromise the viability of the cells and, therefore, may affect the effectiveness of the treatment.
Slovenian: Injiciranje katere koli druge snovi, razen 0,9-odstotne raztopine natrijevega klorida (9 mg/ml), (npr. vodikovega peroksida, metilenskega modrila, raztopin joda ali hipertoničnih raztopin glukoze) (glejte poglavje 4.2 ter poglavje 4.5) v traktih fistule ni dovoljeno pred, med ali po injiciranju zdravila Alofisel, saj lahko to ogrozi viabilnost celic in posledično vpliva na učinkovitost zdravljenja.
English: 2.2 Qualitative and quantitative composition Each vial contains a suspension of 30 million cells (eASC) in 6 mL solution, corresponding to a concentration of 5 million cells/mL.
Slovenian: Ena viala vsebuje suspenzijo 30 milijonov celic (eASC) v 6 ml raztopine, kar ustreza koncentraciji 5 milijonov celic/ml.
English: Darvadstrocel is an expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC).
Slovenian: Darvadstrocel so razmnožene človeške alogenske mezenhimske odrasle matične celice, pridobljene iz maščobnega tkiva (expanded adipose stem cells - eASC).
English: In the ADMIRE-CD study, 63/103 of the eASC-treated patient population were analysed for the presence of donor-specific antibodies (DSA) at baseline and Week 12.
Slovenian: V študiji ADMIRE-CD so v začetku in v 12. tednu analizirali 63/103 populacije bolnikov, ki je prejela eASC glede pojava protiteles proti darovalcu.
English: • stitch up the inner openings of the fistulas.
Slovenian: • zašil notranje odprtine fistul.
English: No association between DSA results and safety or efficacy up to Week 52 was seen in the subset tested.
Slovenian: Po preučitvi podskupine spremljanje do 52. tedna ni bila ugotovljena nobena povezava med pojavnostjo DSA ter varnostjo in učinkovitostjo.
English: Adverse reactions System Organ Class
Slovenian: Neželeni učinki Organski sistem
English: d) Replace the needle with a longer needle, also no thinner than 22G, in order to reach the intended sites of injection.
Slovenian: d) Da boste dosegli želena mesta injiciranja, zamenjajte iglo z daljšo, ki prav tako ne sme biti tanjša od 22G.
English: In Alofisel group, the number of patients who had combined remission at Week 24 and subsequently developed anal abscess/anal fistula by Week 52 was 2.9% (3/103), whereas the number of patients without combined remission at Week 24 who subsequently developed anal abscess/anal fistula by Week 52 was 9.7% (10/103).
Slovenian: V skupini, ki je prejemala zdravilo Alofisel, je bilo število bolnikov, pri katerih je v 24. tednu prišlo do kombinirane remisije ter pri katerih so se naknadno do 52. tedna pojavili analni abscesi/analne fistule, 2,9% (3/103), število bolnikov brez kombinirane remisije v 24. tednu, pri katerih so se naknadno do 52. tedna pojavili analni abscesi/analne fistule, pa je bilo 9,7% (10/103).
English: Each vial contains 6 mL of a suspension of 30 million of darvadstrocel.
Slovenian: Ena viala vsebuje 6 ml suspenzije s 30 milijoni celic darvadstrocela.
English: Description of selected treatment-emergent adverse events (adverse events)
Slovenian: Opis izbranih neželenih učinkov, ki se pojavijo med zdravljenjem
English: Do not store above 25 °C or below 15 °C.
Slovenian: Shranjujte pri temperaturi od 15 °C do 25 °C.
English: Alofisel should be used only after conditioning of the fistulas (see section 4.2).
Slovenian: Pred uporabo zdravila Alofisel je treba obvezno pripraviti fistule (glejte poglavje 4.2).
English: b) Re-suspend the cells by gently tapping the bottom of the vials until a homogeneous suspension is obtained, avoiding bubble formation.
Slovenian: b) Z nežnim trkanjem po dnu vial znova suspendirajte celice, dokler ne dobite homogene suspenzije.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
English: Results of the key secondary endpoints show that the proportion of patients with clinical remission at Week 24 was 55% in the Alofisel group and 42% in the control group (p = 0.052) and the corresponding figures for response were 69% and 55% (p = 0.039).
Slovenian: Rezultati ključnih sekundarnih opazovanih dogodkov kažejo, da je bil v 24. tednu delež bolnikov s klinično remisijo v skupini, ki je prejemala zdravilo Alofisel, 55%, v kontrolni skupini pa 42% (p = 0,052).
English: Preserve the container away from heat and direct light sources and do not refrigerate or freeze.
Slovenian: Vsebnik pri shranjevanju zaščitite pred toploto in neposrednimi viri svetlobe.
English: Lack of de novo DSA generation was observed between Week 12 and Week 52.
Slovenian: Med 12. in 52. tednom so opazili odsotnost nastanka protiteles DSA de novo.
English: The proportion of patients with clinical remission at Week 52 was 59% in the Alofisel group and 41% in the control group (p = 0.012) and corresponding figures for response were 66% and 55% (p = 0.114).
Slovenian: V 52. tednu je bil delež bolnikov s klinično remisijo v skupini, ki je prejemala zdravilo Alofisel, 59%, v kontrolni skupini pa 41% (p = 0,012).
English: Of patients with DSA at Week 12, 7/23 (30%) had cleared DSA by Week 52.
Slovenian: Med bolniki, ki so v 12. tednu imeli protitelesa, specifična za darovalca (donor-specific antibodies - DSA), so pri 7/23 (30%) protitelesa DSA izginila do 52. tedna.
English: • anal fistula
Slovenian: • analna fistula
English: In control group, the number of patients who had combined remission at Week 24 who developed anal abscess/anal fistula by Week 52 was 4.9% (5/102), whereas the number of patients without combined remission at Week 24 who developed anal abscess/anal fistula by Week 52 was 2.9% (3/102).
Slovenian: V kontrolni skupini je bilo število bolnikov, pri katerih je v 24. tednu prišlo do kombinirane remisije ter pri katerih so se do 52. tedna pojavili analni abscesi/analne fistule, 4,9% (5/102), število bolnikov brez kombinirane remisije po 24 tednih, pri katerih so se do 52. tedna pojavili analni abscesi/analne fistule, pa je bilo 2,9% (3/102).
English: Alofisel 5 million cells/mL suspension for injection
Slovenian: Alofisel 5 milijonov celic/ml suspenzija za injiciranje
English: Half of the dose will be injected into the tissue around the inner openings of the fistulas, and half of the dose in the tissue walls along the fistulas.
Slovenian: Polovico odmerka bo injiciral v tkivo okrog notranjih odprtin fistul,
English: What Alofisel contains
Slovenian: Kaj vsebuje zdravilo Alofisel
English: In line with standards for the management of complex perianal fistulas, characterisation of the patient's fistulas is needed prior to treatment.
Slovenian: Pred zdravljenjem je treba določiti značilnosti bolnikovih fistul skladno s standardi za obravnavanje zapletenih perianalnih fistul.
English: There were no patients in Alofisel group with events of proctalgia of severe intensity and 3.9% patients with 4 events in the control group.
Slovenian: V skupini, ki je prejemala zdravilo Alofisel ni bilo dogodkov hude proktalgije, v kontrolni skupini pa so bili 4 taki dogodki (pri 3,9% bolnikov).
English: The active ingredient of Alofisel is darvadstrocel which consists of stem cells which are taken from the fat tissue of a healthy adult donor (so-called allogenic stem cells) and then grown in a laboratory.
Slovenian: Učinkovina v zdravilu Alofisel je darvadstrocel, ki je sestavljen iz matičnih celic, ki so pridobljene iz maščobnegatkivazdravihodraslihdarovalcev(t.i.alogenskihzarodnihcelic)innatogojenev laboratoriju.
English: d) Suture closed the internal openings.
Slovenian: d) Notranje odprtine zaprite s šivi.
English: The active ingredient of Alofisel is darvadstrocel which consists of human stem cells obtained from the fat tissue of a healthy adult donor that are subsequently grown (expanded) in the laboratory and provided at a concentration of 5 million cells per millilitre in vials which each contain 6 millilitres, i.e. 30 million cells per vial.
Slovenian: Te celice se nato gojijo (razmnožujejo) v laboratoriju, na voljo pa so v koncentraciji 5 milijonov celic na mililiter v vialah, ki vsebujejo po 6 mililitrov, t.j.
English: What Alofisel looks like and contents of the pack Alofisel is a suspension for injection.
Slovenian: Zdravilo Alofisel je suspenzija za injiciranje.
English: How to store Alofisel
Slovenian: Shranjevanje zdravila Alofisel
English: How Alofisel is given
Slovenian: Kako se daje zdravilo Alofisel
English: If you get any side effects, talk to your surgeon or doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s kirurgom ali zdravnikom.
English: Keep the product within the outer carton.
Slovenian: Zdravilo shranjujte v zunanji škatli.
English: Up to Week 104, 5 (4.9%) and one (< 1.0%) patients developed 5 and 1 anal fistula serious adverse events in the Alofisel and control groups, respectively.
Slovenian: Do 104. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 5 resnih neželenih dogodkov analne fistule pri 5 (4,9%) bolnikih, v kontrolni skupini pa eden pri enem (< 1,0%) bolniku.
English: Alofisel 5 million cells/mL suspension for injection Darvadstrocel
Slovenian: ALOFISEL 5 milijonov celic/ml suspenzija za injiciranje darvadstrocel injekcija
English: Proctalgia
Slovenian: Proktalgija
English: ALOFISEL 5 million cells/mL suspension for injection Darvadstrocel
Slovenian: Alofisel 5 milijonov celic/ml suspenzija za injiciranje darvadstrocel
English: Up to Week 52, 20 (19.4%) and 14 (13.7%) patients developed 21 and 19 anal abscess adverse events in the Alofisel and control groups, respectively, of which 4 and 5 adverse events in respective groups (3.9% patients in both groups) were of severe intensity.
Slovenian: Do 52. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 21 neželenih dogodkov analnega abscesa pri 20 (19,4%) bolnikih, v kontrolni skupini pa 19 pri 14 (13,7%) bolnikih.
English: Up to Week 52, 11 (10.7%) and 8 (7.8%) patients developed 12 and 8 anal fistula adverse events in the Alofisel and control groups, respectively, none of these being of severe intensity.
Slovenian: Do 52. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 12 neželenih dogodkov analne fistule pri 11 (10,7%) bolnikih, v kontrolni skupini pa 8 pri 8 (7,8%) bolnikih.
English: Up to Week 104, 15 (14.6%) and 8 (7.8%) patients developed 15 and 9 serious adverse events of anal abscess in the Alofisel and control groups, respectively.
Slovenian: Do 104. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 15 resnih neželenih dogodkov analnega abscesa pri 15 (14,6%) bolnikih, v kontrolni skupini pa 9 pri 8 (7,8%) bolnikih.
English: e) Repeat steps (b), (c) and (d) for each of the vials in turn after the cells from one vial have been injected.
Slovenian: Za to boste potrebovali iglo, ki se uporablja na primer za spinalno anestezijo, dolgo približno 90 mm. e) Ko injicirate celice iz ene viale, ponovite korake (b), (c) in (d) za vse ostale viale.
English: Up to Week 52, 15 (14.6%) and 12 (11.8%) patients developed 20 and 17 proctalgia adverse events in the Alofisel and control groups, respectively, none of these events being serious in any group up to Week 104.
Slovenian: Do 52. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 20 neželenih dogodkov proktalgije pri 15 (14,6%) bolnikih, v kontrolni skupini pa 17 pri 12 (11,8%) bolnikih.
English: Each vial contains 6 mL of eASC suspension and is closed with a rubber stopper and a flip-off seal.
Slovenian: Zdravilo Alofisel je na voljo v obliki enega odmerka za zdravljenje, shranjenega v 4 vialah iz stekla vrste I. Ena viala vsebuje 6 ml suspenzije celic eASC, zaprta pa je z gumijastim zamaškom in dvižno zaporko.
English: Warnings and precautions Talk to your doctor or surgeon before youare given Alofisel.
Slovenian: Opozorilainprevidnostniukrepi PredenvamdajozdraviloAlofisel,seposvetujtezzdravnikomalikirurgom.
English: • The other ingredients are:
Slovenian: • Druge sestavine so:
English: The safety and effectiveness in these patients were not evaluated.
Slovenian: Varnosti in učinkovitosti pri teh bolnikih niso ovrednotili.
English: Do not over-exercise and drink plenty of water.
Slovenian: Ne pretiravajte s fizično aktivnostjo in pijte veliko vode.
English: It is especially important to mention the following medicines to your doctor:
Slovenian: Še posebej pomembno je, da zdravniku omenite naslednja zdravila:
English: Close medical supervision and monitoring should continue until the patient recovers.
Slovenian: Zdravniški nadzor in spremljanje je treba nadaljevati, dokler bolnik ne okreva.
English: Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
Slovenian: Samomorilne misli in vedenja so bolj verjetna na začetku zdravljenja.
English: • medicines having an effect on the central nervous system.
Slovenian: • zdravila, ki vplivajo na osrednji živčni sistem.
English: • dementia (loss of memory and other mental abilities) especially if you are elderly.
Slovenian: • demenco (izguba spomina in drugih miselnih sposobnosti), zlasti če ste starejši.
English: Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Slovenian: Ne vozite in ne uporabljajte nobenega orodja ali strojev, dokler ne veste, da to zdravilo na vas ne vpliva negativno.
English: It is not possible to advise on a minimum effective/safe dose in this population.
Slovenian: Pri tej populaciji ni mogoče svetovati glede najmanjšega učinkovitega/varnega odmerka.
English: Dose adjustments due to interactions
Slovenian: Prilagoditve odmerka zaradi interakcij
English: • or had low or high blood pressure.
Slovenian: • ali ste imeli nizek ali visok krvni tlak.
English: Alcohol should be avoided as it can influence how this medicine works.
Slovenian: Izogibati se je treba alkoholu, saj lahko vpliva na delovanje tega zdravila.
English: Remember to take the medicine pack with you so that it is clear what you have taken.
Slovenian: Ne pozabite vzeti ovojnine zdravila s seboj, tako da bo jasno, kaj ste vzeli.
English: The trials included 2,690 patients with the age of 18 years to 65 years.
Slovenian: V preskušanja je bilo vključenih 2690 bolnikov, starih od 18 do 65 let.
English: Results for the (key) secondary outcome parameter and additional endpoints were supportive of the primary endpoint.
Slovenian: Rezultati za (ključni) sekundarni parameter in dodatne parametre so podprli rezultate primarnega parametra.
English: • pain in arms or legs or both,
Slovenian: • bolečine v rokah ali nogah ali v obojem,
English: However, if it is almost time for your next dose, skip the missed dose and continue as usual.
Slovenian: Če pa je že skoraj čas za naslednji odmerek, preskočite pozabljeni odmerek in nadaljujte kot običajno.
English: It does not matter whether you take your medicine with or without food.
Slovenian: Ni pomembno, ali jemljete zdravilo s hrano ali brez nje.
English: These symptoms may occur early during treatment.
Slovenian: Ti simptomi se lahko pojavijo zgodaj med zdravljenjem.
English: There is a chance that the medicine could affect your ability to drive and use machines.
Slovenian: Obstaja možnost, da bi lahko zdravilo vplivalo na vašo sposobnost vožnje in upravljanja strojev.
English: Your medicine will usually be given to you in increasing doses as follows:
Slovenian: Zdravilo vam bo običajno predpisano v čedalje večjih odmerkih, kot sledi:
English: The CGI-S was also assessed in trials 3 and 5 as secondary endpoint.
Slovenian: CGI-S je bil ocenjen tudi v preskušanjih 3 in 5 kot sekundarni kriterij.
English: Thus, DM-3411 is considered not to contribute to the therapeutic effects of brexpiprazole.
Slovenian: Zato se smatra, da DM-3411 ne prispeva k terapevtskim učinkom brekspiprazola.
English: • an electrolyte imbalance (problems with the amount of salts in your blood).
Slovenian: • elektrolitsko neravnovesje (težave s količino soli v krvi).
English: A risk to the new-borns/infants cannot be excluded.
Slovenian: Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
English: Your doctor will consider the benefit of the therapy for you and the benefit of breast-feeding for your baby.
Slovenian: Zdravnik bo upošteval korist zdravljenja za vas in korist dojenja za dojenčka.
English: • withdrawal symptoms in new-born babies if the mother has taken this medicine during pregnancy.
Slovenian: • odtegnitveni simptomi pri novorojenčkih, če je mati jemala zdravilo med nosečnostjo,
English: Generally, these risks are greatest at the beginning of treatment with antipsychotics and during dose escalation.
Slovenian: Na splošno so ta tveganja največja ob začetku zdravljenja z antipsihotiki in med povečanjem odmerka.
English: • have or had a low number of white blood cells in your blood and get a fever or any other sign of infection.
Slovenian: • ste imeli ali imate nizko število belih krvnih celic in ste dobili vročino ali kak drug znak okužbe.
English: Tell your doctor immediately if you have:
Slovenian: Takoj obvestite zdravnika, če imate:
English: • akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
Slovenian: • akatizija (neprijeten občutek notranji nemir in nujna potreba po nenehnem gibanju),
English: At the beginning of treatment the lipid profile should be assessed.
Slovenian: Na začetku zdravljenja je treba oceniti lipidni profil.
English: It should be considered that plasma concentration of brexpiprazole will decline gradually and will be completely washed out in 1 to 2 weeks.
Slovenian: Upoštevati je treba, da se bo koncentracija brekspiprazola v plazmi postopoma zmanjševala in da se bo popolnoma izločil iz telesa v 1 do 2 tednih.
English: • if you are allergic to brexpiprazole or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na brekspiprazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Suicide attempt Suicidal ideation
Slovenian: Poskus samomora Samomorilne misli
English: RXULTI may increase the effect of medicines used to lower the blood pressure.
Slovenian: Zdravilo RXULTI lahko poveča učinek zdravil, ki se uporabljajo za znižanje krvnega tlaka.
English: • are having any thoughts or feelings about hurting yourself or to commit suicide.
Slovenian: • imate kakršne koli misli ali občutke, da bi se želeli samopoškodovati ali storiti samomor.
English: 2500 Valby Denmark
Slovenian: 2500 Valby Danska
English: Purified water
Slovenian: Prečiščena voda
English: Oral use The film-coated tablets can be taken with or without food.
Slovenian: Peroralna uporaba Filmsko obložene tablete se lahko vzame s hrano ali brez nje.
English: The incidence of TEAEs in long-term trials was similar to that of the short-term trials.
Slovenian: Incidenca TEAEs v dolgoročnih preskušanjih je bila podobna kot pri kratkoročnih preskušanjih.
English: Environmental risk assessment (ERA)
Slovenian: Ocena tveganja za okolje
English: The effect of brexpiprazole on blood pressure reduction is attributed to the expected blockade of α1-adrenoceptors in peripheral blood vessels.
Slovenian: Učinek brekspiprazola na znižanje krvnega tlaka se pripisuje pričakovani blokadi α1-adrenoceptorjev v perifernih krvnih žilah.
English: Caution should be exercised when prescribing with other medicinal products.
Slovenian: Pri predpisovanju z drugimi zdravili je potrebna previdnost.
English: Even if you feel better, do not alter or stop your daily dose of RXULTI unless told to do so by your doctor as your symptoms may return.
Slovenian: Tudi če se počutite bolje, ne spreminjajte dnevnega odmerka zdravila RXULTI in ga ne prenehajte jemati, če vam tega ni naročil zdravnik, saj se lahko vaši simptomi vrnejo.
English: It is important that you get your blood checked regularly as this may be fatal.
Slovenian: Pomembno je, da vam redno pregledujejo kri, ker so lahko omenjena stanja usodna.
English: Signs of high blood sugar level are excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak.
Slovenian: Znaki visokega krvnega sladkorja so pretirana žeja, izločanje velikih količin urina, povečanje apetita in občutek oslabelosti.
English: Leukopenia, neutropenia and agranulocytosis
Slovenian: Levkopenija, nevtropenija in agranulocitoza
English: Your doctor will therefore check your weight and your fats in the blood regularly.
Slovenian: Zdravnik bo zato redno preverjal vašo telesno maso in maščobe v krvi.
English: Please inform your doctor if you take any other medicines that are known to prolong the QT interval.
Slovenian: Obvestite zdravnika, če jemljete katero koli drugo zdravilo, za katero je znano, da podaljša interval QT.
English: Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Slovenian: Obvestite zdravnika, če jemljete zdravilo za nadzor krvnega tlaka.
English: Unstructured variance-covariance matrix structure was used.
Slovenian: Uporabljena je bila struktura nestrukturirane variančno-kovariančne matrike.
English: Talk to your doctor about the best way to feed your baby if you are taking RXULTI.
Slovenian: Pogovorite se z zdravnikom o najboljšem načinu hranjenja otroka, če jemljete zdravilo RXULTI.
English: Impulse-control disorders
Slovenian: Motnje nadzora impulzov
English: It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medication was discontinued.
Slovenian: Opozoriti je treba, da so simptomi nadzora impulzov lahko povezani z osnovno motnjo, vendar so v nekaterih primerih poročali, da so se težnje ustavile z zmanjšanjem odmerka ali prekinitvijo zdravljenja z zdravilom.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: • or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Slovenian: • vi ali vaša družina/skrbnik opazite, da se pri vas razvija nagnjenost ali želja po vedenju, ki za vas ni običajno, in se ne morete upreti impulzu, težnji ali skušnjavi po dejanjih, ki bi lahko škodila vam ali drugim.
English: This medicinal product may pose a risk to the environment (see section 5.3).
Slovenian: To zdravilo lahko predstavlja nevarnost za okolje (glejte poglavje 5.3).