FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals present have been reported in patients treated with hydroxocobalamin following known or suspected cyanide poisoning.
Slovenian: Pri bolnikih, zdravljenih s hidroksokobalaminom po znani zastrupitvi s cianidom ali sumu na njo so poročali o primerih akutne odpovedi ledvic z akutno tubularno nekrozo, okvaro ledvic in prisotnostjo kristalov kalcijevega oksalata v urinu.
English: A decrease in blood pressure and a faster heart beat have also been observed in patients who have cyanide poisoning.
Slovenian: Pri bolnikih, ki so se zastrupili s cianidom, so opazili tudi znižanje krvnega tlaka in hitrejše bitje srca.
English: Initial dose Adults: The initial dose of Cyanokit is 5 g (200 mL, complete volume of reconstituted solution).
Slovenian: Odrasli: Začetni odmerek zdravila Cyanokit je 5 g (200 ml, celotna prostornina rekonstituirane raztopine).
English: Haematology Erythrocytes Haematocrit
Slovenian: Hematologija Eritrociti Hematokrit
English: • swelling of ankles
Slovenian: • otekanje gležnjev
English: Amylase
Slovenian: Amilaza
English: In particular, liver fibrosis was observed in dogs after administration of hydroxocobalamin for 4 weeks at 300 mg/kg.
Slovenian: Pri psih, ki so 4 tedne prejemali po 300 mg/kg hidroksokobalamina, so opazili predvsem fibrozo jeter.
English: Paediatric population: In infants to adolescents (0 to 18 years old), the initial dose of Cyanokit is 70 mg/kg body weight not exceeding 5 g.
Slovenian: Pediatrična populacija: Od dojenčkov do mladostnikov (0 do 18 let starosti) je začetni odmerek zdravila Cyanokit 70 mg/kg telesne mase, vendar odmerek ne sme preseči 5 g.
English: Eosinophils
Slovenian: Eozinofilci
English: Mean free and total cobalamins-(III) Cmax values of 113 and 579 µg eq/mL, respectively, were determined following a dose of 5 g Cyanokit (the recommended initial dose).
Slovenian: Po 5-gramskem odmerku zdravila Cyanokit (priporočeni začetni odmerek) je bila povprečna vrednost Cmax prostih kobalaminov-(III) 113, skupnih kobalaminov-(III) pa 579 µg eq/ml.
English: Paediatric population: In infants to adolescents (0 to 18 years old), the subsequent dose of Cyanokit is 70 mg/kg body weight not exceeding 5 g.
Slovenian: Pediatrična populacija: Od dojenčkov do mladostnikov (0 do 18 let starosti) je naslednji odmerek zdravila Cyanokit 70 mg/kg telesne mase, vendar odmerek ne sme preseči 5 g.
English: A decrease in blood pressure was observed in cyanide-poisoned patients.
Slovenian: Pri bolnikih, zastrupljenih s cianidom, so opazili znižanje krvnega tlaka.
English: - haemodialysis.
Slovenian: hemodializo.
English: Cyanokit 5 g powder for solution for infusion
Slovenian: Cyanokit 5 g prašek za raztopino za infundiranje
English: Cyanokit 2.5 g powder for solution for infusion
Slovenian: Cyanokit 2,5 g prašek za raztopino za infundiranje
English: Nervous system disorders
Slovenian: Psihiatrične motnje Nemir.
English: Interference with haemodialysis
Slovenian: Motnje delovanja hemodialize
English: Cyanokit 5 g powder for solution for infusion hydroxocobalamin
Slovenian: Cyanokit 5 g prašek za raztopino za infundiranje hidroksokobalamin
English: Cyanokit 2.5 g powder for solution for infusion hydroxocobalamin
Slovenian: Cyanokit 2,5 g prašek za raztopino za infundiranje hidroksokobalamin
English: The following adverse reactions have been reported in association with Cyanokit use.
Slovenian: Pri uporabi zdravila Cyanokit so poročali o naslednjih neželenih učinkih.
English: No data are available on male and female fertility as well as on peri- and postnatal development.
Slovenian: Podatkov o plodnosti pri samcih in samicah ter o peri- in postnatalnem razvoju ni. Kancerogenega potenciala hidroksokobalamina niso ocenjevali.
English: The vial is to be reconstituted with 200 mL of diluent using the supplied sterile transfer device.
Slovenian: S priloženo sterilno napravo za prenos je treba vialo rekonstituirati z 200 ml topila.
English: • Elderly
Slovenian: • driska
English: How Cyanokit is stored
Slovenian: Shranjevanje zdravila Cyanokit
English: Each vial is to be reconstituted with 100 mL of diluent using the supplied sterile transfer device.
Slovenian: S priloženo sterilno napravo za prenos je treba vsako vialo rekonstituirati s 100 ml topila.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Protrombinski čas (PT)
English: An increase in heart rate was observed in cyanide-poisoned patients.
Slovenian: Pri bolnikih, zastrupljenih s cianidom, so opazili pospešen srčni utrip.
English: Potassium Chloride
Slovenian: Klorid
English: Such side effects may be serious and need immediate attention.
Slovenian: • rdečica kože, koprivnica (urtikarija) ali srbenje Ti neželeni učinki so lahko resni in zahtevajo takojšnje ukrepanje.
English: Uric acid
Slovenian: Bolezni ledvic
English: • restlessness
Slovenian: • omotica
English: Hydrochloric acid (for pH-adjustment)
Slovenian: 6.1 Seznam pomožnih snovi Klorovodikova kislina (za uravnavanje pH)
English: • swelling, irritation, redness.
Slovenian: • otekanje, draženje, rdečica Kožne reakcije
English: Unpredictable***
Slovenian: *** Nekonsistentni rezultati.
English: Posology
Slovenian: Sečnina
English: Psychiatric disorders
Slovenian: Bolezni sečil
English: Cases have also been reported in other Member States leading to regulatory actions.
Slovenian: Tudi v drugih državah članicah so poročali o primerih, kar je privedlo do regulatornih ukrepov.
English: The risk of sensitisation has been investigated in various studies published in recent years.
Slovenian: Tveganje za preobčutljivost so proučevali v različnih študijah, objavljenih v preteklih letih.
English: Home Products de Portugal, Lda.
Slovenian: Portugalska Home Products de Portugal,Lda.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING BUFEXAMAC (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO BUFEKSAMAK (glejte Dodatek I)
English: In addition, the Committee considered that the proposed risk minimisation measures are not appropriate to reduce the risks to an acceptable level.
Slovenian: Poleg tega je Odbor štel predlagane ukrepe za zmanjšanje tveganja kot neustrezne za zmanjšanje tveganja na sprejemljivo raven.
English: Deutsche Medizinische Wochenschrift 2005; Vol 130; 50: 2881-2886) provide evidence for an increased risk of allergic contact dermatitis in the general population of patients using bufexamac.
Slovenian: Nemški medicinski tednik) 2005; zvezek 130; 50: 2881-2886) dokazujejo povečano tveganje za alergijski kontaktni dermatitis pri splošni populaciji bolnikov, ki uporabljajo bufeksamak.
English: Therefore the Committee recommended the revocation of the Marketing Authorisations for the medicinal products referred to in Annex I.
Slovenian: Odbor je zato priporočil odvzem dovoljenj za promet z zdravili, ki so navedena v Dodatku I.
English: The CHMP considered the matter in accordance with Article 107(2) of Directive 2001/83/EC, as amended during the April 2010 CHMP plenary meeting.
Slovenian: CHMP je proučil zadevo v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, na plenarnem zasedanju CHMP aprila 2010.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ODVZEM DOVOLJENJ ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: • to reduce symptoms of 1st and 2nd grade haemorrhoids.
Slovenian: • zmanjšanje simptomov hemoroidov prve in druge stopnje.
English: Many reports described massive, generalised reactions, some of them requiring systemic treatment with corticosteroids or hospitalisation.
Slovenian: V mnogih poročilih so opisovali obsežne, generalizirane reakcije, pri nekaterih od njih pa je bilo potrebno sistemsko zdravljenje s kortikosteroidi ali hospitalizacija.
English: In addition, recent publications on contact allergy (e.g. Gniazdowska 1999, Waltermamm 2009), confirmed that the efficacy of bufexamac in skin diseases is questionable.
Slovenian: Poleg tega so nedavne publikacije o kontaktni alergiji (npr. Gniazdowska 1999, Waltermamm 2009) potrdile, da je učinkovitost bufeksamaka pri kožnih boleznih vprašljiva.
English: Therefore, the CHMP considers that the exposure to bufexamac increases the risk for the occurrence of contact allergic reactions and even prolong in some cases the duration of the disease.
Slovenian: CHMP zato meni, da izpostavljenost bufeksamaku povečuje tveganje za pojav kontaktnih alergijskih reakcij in v nekaterih primerih celo podaljša trajanje bolezni.
English: In addition, most of the about 450 case reports on bufexamac in National Competent Authority's (BfArM, DE) Adverse Drug Reactions (ADR) database relate to ADRs of the skin or of the immune system, including 189 cases of contact dermatitis.
Slovenian: Poleg tega se večina izmed približno 450 poročil o posameznih primerih bufeksamaka v zbirki podatkov o neželenih učinkih nacionalnega pristojnega organa (BfArM, DE) nanaša na neželene učinke na kožo ali na imunski sistem, vključno s 189 primeri kontaktnega dermatitisa.
English: Risk
Slovenian: Tveganje
English: However, the CHMP maintains the opinion that the proposed risk minimisation measures are not sufficient to substantially reduce or avoid the risk of contact allergy in patient populations treated with bufexamac containing medicinal products.
Slovenian: Vendar pa CHMP vztraja pri svojem mnenju, da predlagani ukrepi za zmanjšanje tveganja ne zadoščajo za bistveno zmanjšanje ali preprečevanje tveganja kontaktne alergije v populacijah bolnikov, ki prejemajo zdravila, vsebujoča bufeksamak.
English: The following factors were associated with a significantly increased risk for bufexamac sensitisation: anogenital localisation of eczema, other sensitisations, atopic dermatitis, eczema of the legs, female gender, and geographic factors.
Slovenian: Naslednji dejavniki so bili povezani z bistveno povečanim tveganjem preobčutljivosti za bufeksamak: anogenitalni lokalizaciji ekcem, druge preobčutljivosti, atopični dermatitis, ekcem nog, ženski spol in geografski dejavniki.
English: The CHMP, reviewing evidence from these controlled studies, is of the opinion that, there is only very limited evidence of efficacy for bufexamac in the above mentioned indications.
Slovenian: CHMP po pregledu rezultatov teh nadzorovanih študij meni, da obstajajo le zelo omejeni dokazi učinkovitosti bufeksamaka pri zgoraj navedenih indikacijah.
English: Medicinal products containing bufexamac are authorised in twelve EU Member States presented as ointment, cream, and/or suppository formulations (see Annex I for the list of bufexamac containing medicinal products authorised in the EU).
Slovenian: Zdravila, ki vsebujejo bufeksamak, so odobrena v dvanajstih državah članicah EU v obliki mazila, kreme in/ali pripravkov v obliki svečk (glejte Dodatek I za seznam zdravil, vsebujočih bufeksamak, ki so odobrena v EU).
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing bufexamac.
Slovenian: • Odbor je upošteval postopek po členu 107 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo bufeksamak.
English: Controlled studies demonstrated lower efficacy of bufexamac than active comparators or no difference to placebo.
Slovenian: Nadzorovane študije so dokazale, da je bufeksamak manj učinkovit od aktivnih primerjalnih zdravil oz. da med njim in placebom ni nobene razlike.
English: On 12 January 2010, the Federal Institute for Drugs and Medical Devices (BfArM) issued a Rapid Alert informing the Members States, the European Medicines Agency and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of its intention to revoke the marketing authorisations of all bufexamac containing medicinal products for topical use in Germany due to an increased risk of serious allergic contact dermatitis and risk factors for contact sensitisation to bufexamac.
Slovenian: Dne 12. januarja 2010 je nemški Zvezni inštitut za zdravila in medicinske pripomočke (BfArM) izdal hitro opozorilo, s katerim je države članice, Evropsko agencijo za zdravila in Evropsko komisijo v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, obvestil o svoji nameri, da želi v Nemčiji odvzeti dovoljenja za promet z vsemi zdravili, ki vsebujejo bufeksamak in so namenjena za topično uporabo, zaradi povečanega tveganja za hud alergijski kontaktni dermatitis in dejavnike tveganja kontaktne preobčutljivosti za bufeksamak.
English: • chronic dermatoses,
Slovenian: • kronične dermatoze,
English: • The Committee considered the benefit-risk ratio of bufexamac under the normal conditions of use and considered that the aforementioned evidenced risk of contact allergic reactions is not acceptable, taking into account that the efficacy of bufexamac is limited in the treatment of dermatological and proctological diseases.
Slovenian: • Odbor je ocenil razmerje med koristmi in tveganji za bufeksamak pod normalnimi pogoji uporabe in menil, da zgoraj navedeno dokazano tveganje za kontaktne alergijske reakcije ni sprejemljivo, ob upoštevanju dejstva, da je učinkovitost bufeksamaka omejena le na zdravljenje dermatoloških in proktoloških bolezni.
English: The decision of the German Competent Authority was based on numerous publications and spontaneous reports on contact-allergic reactions following the administration of medicinal products containing bufexamac and recent publications of data on the incidence of and the risk factors for contact sensitisation to bufexamac.
Slovenian: Odločitev nemškega pristojnega organa je temeljila na številnih publikacijah in spontanih poročilih o kontaktnih alergijskih reakcijah po dajanju zdravil, vsebujočih bufeksamak, in nedavnih objavah podatkov o pojavnosti in dejavnikih tveganja za kontaktno preobčutljivost za bufeksamak.
English: Taking all these elements into account, the CHMP concluded that the medicinal products containing bufexamac for topical use are harmful under the normal conditions of use, and that the benefit/risk balance for bufexamac is not considered favourable.
Slovenian: Ob upoštevanju vseh teh elementov je CHMP sklenil, da so zdravila, ki vsebujejo bufeksamak in so namenjena za topično uporabo, pod normalnimi pogoji uporabe škodljiva in da razmerje med koristmi in tveganji za bufeksamak ni ugodno.
English: Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) recommends the revocation of the Marketing Authorisations for all bufexamac containing medicinal products listed in Annex I.
Slovenian: V skladu z določbami člena 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji priporočil odvzem dovoljenj za promet z vsemi zdravili, ki vsebujejo bufeksamak in so navedena v Dodatku I.
English: • The Committee concluded, after having reviewed the available data, that bufexamac for topical use is harmful under normal conditions of use due to cutaneous effects and particularly to contact allergic reactions, some of which are serious, generalised or requiring hospitalisation.
Slovenian: • Odbor je po pregledu razpoložljivih podatkov zaključil, da je bufeksamak za topično uporabo pod normalnimi pogoji uporabe škodljiv zaradi učinkov na kožo, zlasti zaradi kontaktnih alergijskih reakcij (nekatere med njimi so bile hude, generalizirane ali so zahtevale hospitalizacijo).
English: Updated results of the postmarketing experience regarding the serious allergic contact dermatitis with bufexamac and data from a recent publication on this subject (e.g. Schnuch A et al.: A common and insidious side-effect: Allergic contact dermatitis caused by bufexamac used in the treatment of dermatitis.
Slovenian: Posodobljeni rezultati iz obdobja trženja zdravila s hudim alergijskim kontaktnim dermatitisom pri bufeksamaku in podatki iz nedavne publikacije na to temo (npr. Schnuch A. et al.: A common and insidious side-effect: Allergic contact dermatitis caused by bufexamac used in the treatment of dermatitis.
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EEA)
Slovenian: DODATEK I SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVIL IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH (EGP)
English: Luxembourg PF MEDICAMENT 45, Place Abel Gance 92654 Boulogne Cedex France
Slovenian: Luksemburg PF MEDICAMENT 45, Place Abel Gance 92654 Boulogne Cedex France
English: • hyperkeratotic conditions, chronic und subacute, - Proctological
Slovenian: • hiperkeratotična stanja, kronična in subakutna, - proktološke bolezni
English: It is especially of concern that the clinical picture of the undesirable effect (contact allergic eczema) is identical or very similar to the disease to be treated, leading to misdiagnosis, a delay in diagnosis and prolongation of the disease.
Slovenian: Zlasti je zaskrbljujoče, da je klinična slika neželenih učinkov (kontaktnega alergijskega ekcema) enaka ali zelo podobna kot pri bolezni, ki jo je treba zdraviti, kar prispeva k nepravilni diagnozi, podaljšanju časa do diagnoze in podaljšanju trajanja bolezni.
English: Despite measures being taken at national level in various Member States, the cutaneous effects and particularly the contact allergic reactions, some of which serious, generalised or requiring hospitalisation caused by bufexamac containing medicinal products for topical use have continued to occur.
Slovenian: Kljub sprejetim ukrepom na nacionalni ravni v različnih državah članicah so se še naprej pojavljali učinki na kožo, zlasti kontaktne alergijske reakcije (nekatere med njimi so bile hude, generalizirane ali so zahtevale hospitalizacijo) na zdravila, ki vsebujejo bufeksamak in so namenjena za topično uporabo.
English: • dermatitis, chronic and subacute,
Slovenian: • dermatitis, kronični in subakutni,
English: Since the granting of the marketing authorisations, several reviews on these medicinal products have been performed at national levels leading to changes of the Summary of product characteristics (SPC), labelling, package leaflet, or change to the legal status from non-prescription to prescription only medicine.
Slovenian: Od odobritve dovoljenj za promet dalje je bilo izvedenih več pregledov teh zdravil na nacionalni ravni, zaradi česar so bili spremenjeni povzetek glavnih značilnosti zdravila, označevanje, navodilo za uporabo ter pravni status iz zdravila, ki je na voljo brez recepta, v zdravilo, ki se dobi samo na recept.
English: Therefore, the CHMP is of the opinion that Bufexamac is a potent sensitizer in a high proportion of patients exposed even after short-term use leading to adverse reactions (contact allergies, severe or generalised in some cases) that can not be distinguished clinically from the diseases to be treated leading to misdiagnosis or late correct diagnostic of the allergy and consequently worsening the disease to be treated.
Slovenian: CHMP zato meni, da je bufeksamak močan povzročitelj preobčutljivosti, ki pri velikem deležu bolnikov (tudi pri zelo kratkotrajni izpostavljenosti) povzroči neželene učinke (kontaktne alergije, ki so v nekaterih primerih hude ali generalizirane), ki jih ni mogoče klinično razlikovati od bolezni, ki jih je treba zdraviti, kar vodi do nepravilne diagnoze ali pozne pravilne diagnoze alergije in posledično do poslabšanja bolezni, ki jo je treba zdraviti.
English: • to reduce inflammatory symptoms of skin in neurodermatitis and chronic eczema,
Slovenian: • zmanjšanje simptomov kožnega vnetja pri nevrodermatitisu in kroničnemu ekcemu,
English: GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATIONS
Slovenian: PODLAGA ZA ODVZEM DOVOLJENJ ZA PROMET Z ZDRAVILOM
English: Based on the aforementioned data, especially with regard to the clinical manifestation of these ADRs compared with the symptoms to be treated, the CHMP concludes that the clinical picture of the undesirable effects (contact allergic eczema) is identical or very similar to the symptomatology of the disease to be treated (contributing to misdiagnosis, a delay in correct diagnosis and prolongation of the disease).
Slovenian: CHMP je na podlagi zgoraj navedenih podatkov, zlasti glede kliničnih znakov teh neželenih učinkov v primerjavi s simptomi, ki jih je treba zdraviti, sklenil, da je klinična slika neželenih učinkov (kontaktnega alergijskega ekcema) enaka ali zelo podobna simptomatologiji bolezni, ki jo je treba zdraviti (kar prispeva k nepravilni diagnozi, podaljšanju časa do pravilne diagnoze in podaljšanju trajanja bolezni).
English: • The Committee, in light of the above findings, concluded that the benefit/risk balance of bufexamac containing medicinal products for topical use is not favourable under the normal conditions of use.
Slovenian: • Odbor je na podlagi zgoraj navedenih ugotovitev zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo bufeksamak in so namenjena za topično uporabo, pod normalnimi pogoji uporabe ni ugodno.
English: The updated results of the postmarketing experience regarding the serious allergic contact dermatitis with bufexamac and data from recent publications on this subject show that bufexamac exhibits questionable efficacy in association with high allergenic potential.
Slovenian: Posodobljeni rezultati iz obdobja trženja zdravila v zvezi s hudim alergijskim kontaktnim dermatitisom pri bufeksamaku in podatki iz nedavnih publikacij na to temo kažejo, da je učinkovitost bufeksamaka ob upoštevanju njegovega visokega alergenskega potenciala vprašljiva.
English: It should also be noted that significant differences between epidemiological data and the number of spontaneous reports on contact dermatitis in the various pharmacovigilance databases clearly suggest significant underreporting and probably underestimation of the frequency of contact-allergic reactions.
Slovenian: Poudariti je treba tudi, da bistvene razlike med epidemiološkimi podatki in številom spontanih poročil o kontaktnem dermatitisu v različnih zbirkah podatkov o farmakovigilanci jasno kažejo na bistveno premajhno pogostost poročanja in morebitno podcenjevanje pogostosti kontaktnih alergijskih reakcij.
English: Additional data on the incidence of contact allergies to bufexamac showed that in a sample of ca. 40.000 patch-tested patients, 1.4% exhibited sensitisation to bufexamac.
Slovenian: 40 000 z obližem testiranih bolnikov pri 1,4 % bolnikov razvidna preobčutljivost za bufeksamak.
English: Furthermore, significant differences between epidemiological data and the number of spontaneous reports on contact dermatitis in the various pharmacovigilance databases clearly suggest significant underreporting and probably underestimation of the frequency of contact-allergic reactions.
Slovenian: Poleg tega bistvene razlike med epidemiološkimi podatki in številom spontanih poročil o kontaktnem dermatitisu v različnih zbirkah podatkov o farmakovigilanci jasno kažejo na bistveno premajhno pogostost poročanja in verjetno podcenjevanje pogostosti kontaktnih alergijskih reakcij.
English: • anal fissure,
Slovenian: • analna fisura,
English: Moreover, the pre-existence of some of the indicated diseases to be treated may constitute risk factors for bufexamac sensitisation.
Slovenian: Poleg tega lahko predhodni obstoj nekaterih indiciranih bolezni, ki jih je treba zdraviti, pomeni dejavnike tveganja za preobčutljivost na bufeksamak.
English: 50mg Bufexamac (+5mg Lidocaine)/ 1g ointment
Slovenian: 50mg Bufexamac (+5mg Lidocaine)/ 1g
English: Bufexamac is a non-steroidal anti-inflammatory drug (NSAID) authorised for topical treatment of dermatological and proctological diseases, as follows: - Dermatological
Slovenian: Bufeksamak je nesteroidno protivnetno zdravilo (NSAID), odobreno za topično zdravljenje dermatoloških in proktoloških bolezni, kot so: - dermatološke bolezni