FrancophonIA/ELRC3.0 huggingface dataset:
English: Gentle pressing of the occlusive dressing at the area of contact with the adhesive barrier will ensure adherence between the occlusive film and the barrier and achieve complete containment of NexoBrid on the treatment area.
Slovenian: Z nežnim pritiskom na okluzivno oblogo na predelu stika z adhezivno pregrado je mogoče zagotoviti prileganje okluzivnega filma in pregrade in doseči, da ostane vso zdravilo NexoBrid znotraj zdravljenega predela.
English: Accidental eye exposure must be avoided.
Slovenian: Nezgodno izpostavitev očes morate preprečiti.
English: • Pain management must be used as commonly practiced for an extensive dressing change; it should be initiated at least 15 minutes prior to NexoBrid application.
Slovenian: • Pri obsežni menjavi oblog morate uporabiti običajen način obvladovanja bolečine, ki ga je treba bolniku dati vsaj 15 minut pred nanosom zdravila NexoBrid.
English: In the patients with indications of higher absorption, dose-normalised (per gram of NexoBrid) AUClast ranged from 4500-9820 ngh/ml per gram of NexoBrid.
Slovenian: Pri bolnikih z nakazano višjo absorpcijo je bil AUClast, normaliziran na odmerek (na gram zdravila NexoBrid), v razponu 4.500-9.820 ngh/ml na gram zdravila NexoBrid.
English: Removal of topically applied antibacterial medicinal products before NexoBrid application
Slovenian: Odstranite vseh topikalno nanesenih antibakterijskih zdravil pred nanosom zdravila NexoBrid
English: Concentrate of proteolytic enzymes enriched in bromelain: 0.09 g/g (or 5 g/55 g gel) after mixing.
Slovenian: Koncentrat proteolitičnih encimov, obogatenih z bromelainom: 0,09 g/g (ali 5 g/55 g gela) po mešanju.
English: • NexoBrid will be applied to a wound area that is clean, blister free, and moist.
Slovenian: • Zdravilo NexoBrid vam bo zdravnik nanesel na predel rane, ki je čist, brez mehurjev in vlažen.
English: NexoBrid is provided as a powder and gel for gel (powder in a vial (5 g) and gel in a bottle (50 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel.
Slovenian: Zdravilo NexoBrid je na voljo v obliki praška in gela za gel (prašek v viali (5 g) in gel v steklenički (50 g)), velikost pakiranja 1 (pakiranje vsebuje eno vialo s praškom in eno stekleničko z gelom).
English: e.g. urinary tract infections, viral infections) were reported more frequently in the NexoBrid group (0.147 events per patient) than in the group treated according to SOC (0.079 events per patient).
Slovenian: V kliničnih študijah 2. faze in 3. faze so o splošnih okužbah (nepovezano z rano, npr. okužbe sečil, virusne okužbe) pogosteje poročali v skupini, zdravljeni z zdravilom NexoBrid (0,147 dogodka na bolnika), kot v skupini, zdravljeni s standardno nego (0,079 dogodka na bolnika).
English: NexoBrid application
Slovenian: dermalna uporaba
English: SOC (Number of wounds)
Slovenian: Standardna nega (število ran)
English: • The NexoBrid powder vial must be opened by carefully tearing off the aluminium cap and removing the rubber stopper.
Slovenian: • Vialo s praškom zdravila NexoBrid morate previdno odpreti, tako da odtrgate aluminijasto zaporko in odstranite gumijasti zamašek.
English: An increase in heart rate (including tachycardia), reduction of platelet aggregation and plasma fibrinogen levels and a moderate increase in partial thromboplastin and prothrombin times have been reported in the literature as possible effects following oral administration of bromelain.
Slovenian: Kot o možnih neželenih učinkih po peroralnem dajanju bromelaina so v literaturi poročali o hitrejšem bitju srca (vključno s tahikardijo), zmanjšani agregaciji trombocitov in ravni fibrinogenov v plazmi ter zmernem povečanju delnega tromboplastinskega in protrombinskega časa.
English: % of wounds requiring surgery % of wound area excised or dermabraded
Slovenian: Število ran % ran, ki jih je treba operirati % predela ran z ekscizijo ali dermabrazijo
English: Concentrate of proteolytic enzymes enriched in bromelain: 0.09 g/g (or 2 g/22 g gel) after mixing.
Slovenian: Koncentrat proteolitičnih encimov, obogatenih z bromelainom: 0,09 g (ali 2 g/22 g gela) po mešanju.
English: 5 g powder in a vial (glass type II) sealed with a rubber (bromobutyl), stopper and covered with a cap (aluminium), and 50 g gel in a bottle (borosilicate, glass type I), sealed with a rubber stopper and covered with a screw cap (tamper-proof polypropylene).
Slovenian: 5 g praška v viali (steklo tipa II), zamašeni z gumijastim (bromobutilnim) zamaškom, prekriti z zaporko (aluminij), in 50 g gela v steklenički (borosilikat iz stekla tipa I), zamašeni z gumijastim zamaškom in prekriti z varnostno navojno zaporko (polipropilen, ki se poškoduje ob odpiranju).
English: 2 g powder in a vial (glass type II) sealed with a rubber (bromobutyl), stopper and covered with a cap (aluminium), and 20 g gel in a bottle (borosilicate, glass type I), sealed with a rubber stopper and covered with a screw cap (tamper-proof polypropylene).
Slovenian: 2 g praška v viali (steklo tipa II), zamašeni z gumijastim (bromobutilnim) zamaškom, prekriti z zaporko (aluminij), in 20 g gela v steklenički (borosilikat iz stekla tipa I), zamašeni z gumijastim zamaškom in prekriti z varnostno navojno zaporko (polipropilen, ki se poškoduje ob odpiranju).
English: Mixed wounds (with partial and full-thickness area) requiring excision/dermabrasion (surgery) NexoBrid
Slovenian: Mešane rane (z dermalnimi in subdermalnimi predeli), ki potrebujejo ekscizijo/dermabrazijo (operativni poseg)
English: NexoBrid 2 g powder and gel for gel
Slovenian: NexoBrid 2 g prašek in gel za gel
English: There is no information on the use of NexoBrid in patients with hepatic impairment.
Slovenian: Ni podatkov o uporabi zdravila NexoBrid pri bolnikih z okvaro jeter.
English: Examples of such medicines are: - amiodarone (used to treat certain forms of irregular heartbeat), - amodiaquine and chloroquine (used to treat malaria and some forms of inflammation), - fluvastatin (used to treat high cholesterol), - pioglitazone, rosiglitazone, repaglinide, tolbutamide and glipizide (used to treat diabetes), - paclitaxel and sorafenib (used to treat cancer), - torasemide (used to increase urine flow), - ibuprofen ( used to treat fever, pain and some forms of inflammation), - losartan (used to treat high blood pressure), - celecoxib (used to treat some forms of inflammation), - warfarin (used to reduce blood coagulation), and - phenytoin (used to treat epilepsy).
Slovenian: - torazemid (uporablja se za povečanje izločanja urina), - ibuprofen (uporablja se za zdravljenje povišane telesne temperature, bolečine in nekaterih oblik vnetja), - losartan (uporablja se za zdravljenje visokega krvnega tlaka), - celekoksib (uporablja se za zdravljenje nekaterih vrst vnetja), - varfarin (uporablja se za zmanjšanje strjevanja krvi) in - fenitoin (uporablja se za zdravljenje epilepsije).
English: In the other patients, dose-normalised AUClast ranged from 887-3930 ngh/ml per gram of NexoBrid.
Slovenian: Pri ostalih bolnikih je bil razpon AUClast, normaliziran na odmerek, od 8873.930 ng/ml na gram zdravila NexoBrid.
English: • Appropriate preventive analgesia medicinal products must be administered.
Slovenian: • Bolniku morate dati ustrezen analgetik.
English: Carbomer 980 disodium phosphate anhydrous Sodium hydroxide Water for injections
Slovenian: Gel karbomer 980 brezvodni natrijev hidrogenfosfat natrijev hidroksid voda za injekcije
English: Posology 2 g NexoBrid powder in 20 g gel is applied to a burn wound area of 100 cm
Slovenian: Zdravilo NexoBrid 2 g prašek, vmešan v 20 g gel se nanese na predel opeklinske rane površine 100 cm
English: NexoBrid should be applied to a clean, keratin-free (blisters removed), and moist wound area.
Slovenian: Zdravilo NexoBrid se nanese na čist in vlažen predel ranjene kože, na katerem ni keratina (mehurji so odstranjeni).
English: All topically applied antibacterial medicinal products must be removed before applying NexoBrid.
Slovenian: Pred nanosom zdravila NexoBrid je treba odstraniti vsa topikalno nanesena antibakterijska zdravila.
English: The other ingredients are: for the powder: ammonium sulphate and acetic acid and for the gel carbomer 980, disodium phosphate anhydrous, sodium hydroxide, and water for injections.
Slovenian: Druge sestavine so: prašek: amonijev sulfat in ocetna kislina; gel: karbomer 980, brezvodni natrijev hidrogenfosfat, natrijev hidroksid, voda za injekcije.
English: This endpoint can only be evaluated for deep partial-thickness wounds without full-thickness areas because full-thickness burns always require grafting.
Slovenian: Ta opazovani dogodek je bil ocenjen le za globoke dermalne opekline, saj je treba pri subdermalnih opeklinah vedno uporabiti presadek.
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 30.0%, 5.6% and 1.1% of patients, respectively.
Slovenian: V skupini z zdravilom NexoBrid je bil pojav pri 30,0 % bolnikov ocenjen kot blag, pri 5,6 % kot zmeren in pri 1,1 % kot hud.
English: • Sterile isotonic sodium chloride 9 mg/ml (0.9%) solution must be sprinkled on the burn wound.
Slovenian: • Na opeklinsko rano morate nakapati sterilno izotonično 0,9-odstotno raztopino natrijevega klorida (9 mg/ml).
English: • NexoBrid powder is then transferred into the corresponding gel bottle.
Slovenian: • Prašek zdravila NexoBrid nato prenesite v ustrezno stekleničko z gelom.
English: Mixed wounds (deep partial and full thickness) Non-autografted mixed wounds
Slovenian: Mešane rane (dermalne in subdermalne) Mešane rane brez avtotransplantata
English: One vial contains 5 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 5 g/55 g gel).
Slovenian: Ena viala vsebuje 5 g koncentrata proteolitičnih encimov, obogatenih z bromelainom, kar po mešanju ustreza 0,09 g/g koncentrata proteolitičnih encimov, obogatenih z bromelainom (ali 5 g/55 g gela).
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 0.9%, 0.9%, and 1.8% of patients, respectively.
Slovenian: V skupini z zdravilom NexoBrid so bili dogodki pri 0,9 % ocenjeni kot blagi, pri 0,9 % kot zmerni in 1,8 % kot hudi.
English: In studies implementing routine antibacterial soaking of the treatment area before and after NexoBrid application (see section 4.2) pyrexia or hyperthermia was reported in 19.1% of patients treated with NexoBrid and in 15.8% of the control patients treated according standard of care.
Slovenian: V študijah, kjer so rutinsko uporabljali protibakterijsko namakanje zdravljenega predela pred nanosom zdravila NexoBrid in po njem (glejte poglavje 4.2) pri 19,1 bolniku zdravljenem z zdravilom NexoBrid in pri 15,8 % bolnikov iz kontrolne skupine, zdravljenih s standardno nego, poročali o pireksiji ali hipertermiji.
English: One vial contains 2 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 2 g/22 g gel).
Slovenian: Ena viala vsebuje 2 g koncentrata proteolitičnih encimov, obogatenih z bromelainom, kar po mešanju ustreza 0,09 g/g koncentrata proteolitičnih encimov, obogatenih z bromelainom (ali 2 g/22 g gela).
English: Deep partial-thickness wounds requiring excision/dermabrasion (surgery) Number of wounds % of wounds requiring surgery % of wound area excised or dermabraded
Slovenian: Zdravilo NexoBrid Standardna nega vrednost p Globoke dermalne opekline, ki potrebujejo ekscizijo/dermabrazijo (operativni poseg) Število ran % ran, ki jih je treba operirati % predela ran z ekscizijo ali dermabrazijo
English: NexoBrid 5 g powder and gel for gel
Slovenian: NexoBrid 5 g prašek in gel za gel
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 9.1%, 9.1%, and 0% of patients, respectively.
Slovenian: V skupini z zdravilom NexoBrid je bil pojav pri 9,1 % bolnikov ocenjen kot blag, 9,1 % kot zmeren in 0 % kot hud.
English: • The dressed wound must be covered with a loose, thick fluffy dressing, held in place with a bandage.
Slovenian: • Rano z oblogo morate prekriti z ohlapno, debelo in kosmičavo oblogo ter jo pritrditi z ovojem.
English: An aseptic technique must be used when mixing the powder with the gel.
Slovenian: Pri mešanju praška z gelom morate uporabiti aseptično tehniko.
English: • NexoBrid powder and gel must be mixed thoroughly until a uniform, slightly tan to slightly brown mixture is obtained.
Slovenian: • Zdravilo NexoBrid prašek in gel morate dobro premešati, da dobite enakomerno, rahlo svetlorjavo do rjavkasto mešanico.
English: Wound complication*
Slovenian: zapleti z rano*
English: In case of skin exposure, rinse NexoBrid off with water.
Slovenian: V primeru izpostavljenosti kože izpirajte zdravilo NexoBrid z vodo.
English: • Before a permanent skin cover or temporary skin substitute is applied to a freshly enzymatically debrided area, a soaking wet-to-dry dressing must be applied.
Slovenian: • Pred nanosom trajnega kožnega presadka ali začasnega kožnega nadomestka na sveže encimsko očiščeno rano morate rano prekriti z oblogo, ki je na rano mokra in navzven suha.
English: In case of eye exposure, irrigate exposed eyes with copious amounts of water for at least 15 minutes.
Slovenian: Če pride do izpostavitve, izpostavljene oči vsaj 15 minut izpirajte z veliko vode.
English: What NexoBrid looks like and contents of the pack NexoBrid is provided as a powder and gel for gel (powder in a vial (2 g) and gel in a bottle (20 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel)
Slovenian: Zdravilo NexoBrid je na voljo v obliki praška in gela za gel (prašek v viali (2 g) in gel v steklenički (20 g)), velikost pakiranja 1 (pakiranje vsebuje eno vialo s praškom in eno stekleničko z gelom).
English: • A total wound area of not more than 15% TBSA can be treated by NexoBrid.
Slovenian: • V enem postopku se lahko zdravilo NexoBrid nanese na največ 15 % CPT.
English: NexoBrid 2 g powder and gel for gel Concentrate of proteolytic enzymes enriched in bromelain
Slovenian: NexoBrid 2 g prašek in gel za gel koncentrat proteolitičnih encimov, obogatenih z bromelainom
English: What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 2 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Slovenian: Kaj vsebuje zdravilo NexoBrid - Zdravilna učinkovina (v prašku v viali) je koncentrat proteolitičnih encimov, obogatenih z bromelainom: 2 g, kar po mešanju ustreza 0,09 g/g koncentrata proteolitičnih encimov, obogatenih z bromelainom.
English: What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 5 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Slovenian: Kaj vsebuje zdravilo NexoBrid - Zdravilna učinkovina (v prašku v viali) je koncentrat proteolitičnih encimov, obogatenih z bromelainom: 5 g, kar po mešanju ustreza 0,09 g/g koncentrata proteolitičnih encimov, obogatenih z bromelainom.
English: Excipients: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Slovenian: Pomožne snovi: karbomer 980, brezvodni natrijev hidrogenfosfat, natrijev hidroksid, voda za injekcije.
English: NexoBrid 5 g powder and gel for gel Concentrate of proteolytic enzymes enriched in bromelain
Slovenian: NexoBrid 5 g prašek in gel za gel koncentrat proteolitičnih encimov, obogatenih z bromelainom
English: Excipients for the gel: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Slovenian: Pomožne snovi za gel: karbomer 980, brezvodni natrijev hidrogenfosfat, natrijev hidroksid, voda za injekcije.
English: There have been reports of serious allergic reactions including anaphylaxis (with manifestations such as rash, erythema, hypotension, tachycardia) in patients undergoing debridement with NexoBrid.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom NexoBrid, obstajajo poročila o resnih alergijskih reakcijah, vključno z anafilakso (ki se kažejo z izpuščajem, eritemom, hipotenzijo, tahikardijo).
English: General principles of proper burn wound care must be adhered to when using NexoBrid.
Slovenian: Pri uporabi zdravila NexoBrid upoštevajte splošna načela pravilnega čiščenja opeklinskih ran.
English: • Before NexoBrid application, a dressing soaked with an antibacterial solution will be applied for 2 hours.
Slovenian: • Pred nanosom zdravila NexoBrid vam bodo na rano za 2 uri položili oblogo, namočeno v antibakterijsko raztopino.
English: Wound complications
Slovenian: Okvara ledvic
English: Full Thickness wounds
Slovenian: Subdermalne rane
English: NexoBrid is not recommended for use on: - penetrating burn wounds where foreign materials (e.g. implants, pacemakers, and shunts) and/ or vital structures (e.g. larger vessels, eyes) are or could become exposed during debridement.
Slovenian: Zdravilo NexoBrid se ne priporoča za uporabo pri: - prodirajočih opeklinskih ranah z izpostavitvijo ali možno izpostavitvijo tujkov (npr. vsadkov, spodbujevalnikov in šantov) in/ali vitalnih struktur (npr. velikih žil, oči) med čiščenjem, - kemičnih opeklinskih ranah, - ranah, kontaminiranih z radioaktivnimi ali drugimi nevarnimi snovmi, da se preprečijo nepredvidljive reakcije z zdravilom in zaradi večjega tveganja širjenja nevarnih snovi.
English: • All topically applied antibacterial medicinal products must be removed before applying NexoBrid.
Slovenian: • Pred nanosom zdravila NexoBrid morate odstraniti vsa topikalno nanesena antibakterijska zdravila.
English: Topically applied medicinal products (such as silver sulfadiazine or povidone-iodine) at the wound site must be removed and the wound cleansed prior to NexoBrid application.
Slovenian: Pred nanosom zdravila NexoBrid je treba topikalno nanesena zdravila (kot sta srebrov sulfadiazin ali povidon-jod) z rane odstraniti in rano očistiti.
English: % wound area autografted 55.5% (n=48)
Slovenian: 55,5 % (n = 48)
English: • A dressing soaked with an antibacterial solution must be applied for an additional 2 hours.
Slovenian: • Na rano morate za še 2 uri položiti oblogo, namočeno z antibakterijsko raztopino.
English: Autografted mixed wounds
Slovenian: % avtotransplantiranega predela rane
English: There is limited information on the use of NexoBrid on facial burn wounds.
Slovenian: Podatkov o uporabi zdravila NexoBrid pri opeklinskih ranah na obrazu je malo.
English: OUTER CARTON
Slovenian: ZUNANJA ŠKATLA
English: In case of skin contact, rinse NexoBrid off with water.
Slovenian: V primeru, da je zdravilo prišlo v stik s kožo, izpirajte zdravilo NexoBrid z vodo.
English: • Dressing soaked with an antibacterial solution must be applied for 2 hours.
Slovenian: • Na rano morate za 2 uri položiti oblogo, namočeno z antibakterijsko raztopino.
English: - Keep this leaflet.
Slovenian: Shranjujte pokončno.
English: Aseptic technique must be used when mixing NexoBrid powder with the gel.
Slovenian: Pri mešanju zdravila NexoBrid prašek z gelom morate uporabiti aseptično tehniko.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING UNITS
Slovenian: Izhodiščne značilnosti vseh mešanih opeklin
English: Wound Type
Slovenian: Vrsta rane
English: Size: % mean TBSA Depth: Superficial (%TBSA) DPT (% TBSA) FT (% TBSA) Incidence of autograft
Slovenian: Velikost: % povprečje CPT 7,43 Globina: Površinske (% CPT) Globoke dermalne (% CPT) 3,85 Subdermalne (% CPT) Incidenca avtotransplantata 70,8 % (34/48)
English: NexoBrid should not be applied to more than 15% Total Body Surface Area (TBSA) (see also section 4.4, Coagulopathy).
Slovenian: Zdravilo NexoBrid 2 g praška v 20 g gela se nanese na predel opeklinske rane površine 100 cm V enem postopku nanašanja zdravila NexoBrid ne nanesite na več kot 15 % celotne površine telesa (CPT) (glejte tudi poglavje 4.4, Koagulopatija).
English: Concentrate of proteolytic enzymes enriched in bromelain
Slovenian: NexoBrid 5 g prašek koncentrat proteolitičnih encimov, obogateni z bromelainom
English: Based on:
Slovenian: Na podlagi:
English: Scientific conclusions and grounds for refusal and suspension presented by the European Medicines Agency
Slovenian: Znanstveni zaključki ter podlaga za zavrnitev in začasni umik, ki jih je predstavila Evropska agencija za zdravila
English: • the rapporteur's and co-rapporteur's assessment reports
Slovenian: • poročil poročevalca in soporočevalca o oceni zdravila,
English: Isotretinoin Ranbaxy 10 mg & 20 mg, capsules (soft) was authorised in the reference member state (UK) under Article 10 of Directive 2001/83/EC and the application was submitted in the concerned member states (France and Spain) under the mutual recognition procedure.
Slovenian: Zdravilo Isotretinoin Ranbaxy 10 mg in 20 mg, kapsule (mehke) je bilo odobreno v referenčni državi članici (Združenem kraljestvu) v skladu s členom 10 Direktive 2001/83/ES, vloga pa je bila predložena v zadevnih državah članicah (Franciji in Španiji) v skladu s postopkom z medsebojnim priznavanjem.
English: However, the results failed to show that the Isotretinoin Ranbaxy generic is bioequivalent to the originator product in real conditions of use (fed conditions), as the 90% confidence intervals (CI) fell outside the predefined interval of 80-125%, which constitutes a risk to public health.
Slovenian: Rezultati so pokazali, da generično zdravilo Isotretinoin Ranbaxy ni biološko enakovredno originatorskemu zdravilu v dejanskih pogojih uporabe (jemanje s hrano), saj je 90 % intervalov zaupanja bilo zunaj predhodno določenega intervala 80 %-125 %, kar predstavlja tveganje za javno zdravje.
English: At the time of the initial authorisation, bioequivalence was shown under fasting conditions (study No 237/00).
Slovenian: V času prvotne odobritve je bila dokazana biološka enakovrednost pri jemanju zdravila na tešče (študija št. 237/00).
English: Therefore, the Committee adopted an opinion recommending the refusal of the marketing authorisations in the concerned member states and the suspension of the marketing authorisations in the reference member state, subject to the conditions outlined in annex III of the Opinion.
Slovenian: Odbor je zato sprejel mnenje, v katerem priporoča zavrnitev dovoljenj za promet z zdravilom v zadevnih državah članicah in začasni umik dovoljenj za promet z zdravilom v referenčni državi članici v skladu s pogoji, opredeljenimi v Dodatku III tega mnenja.
English: It is therefore considered that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Slovenian: Na podlagi tega velja, da podatki, predloženi v podporo vlogi, ne izpolnjujejo zahtev iz člena 10 Direktive 2001/83/ES, kakor je bila spremenjena.
English: • and scientific discussion within the Committee the CHMP was of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Slovenian: • znanstvene razprave znotraj odbora je CHMP menil, da podatki, predloženi v podporo vlogi, ne izpolnjujejo zahtev iz člena 10 Direktive 2001/83/ES, kakor je bila spremenjena.
English: The totality of data submitted does not support the conclusion that the product is bioequivalent.
Slovenian: Skupni predloženi podatki ne podpirajo trditve, da je zdravilo biološko enakovredno.
English: Isotretinoin is effective against severe acne via a direct effect on the size and activity of sebaceous glands, plus a probable dermal anti-inflammatory effect.
Slovenian: Izotretinoin je učinkovit proti hudim oblikam aken, ker deluje neposredno na velikost in aktivnost lojnic, verjetno pa ima tudi dermalni protivnetni učinek.