natgillin/translations-raw huggingface dataset:
Survival of cyanide-poisoned dogs 
Preživetje psov, zastrupljenih s cianidom
Swelling, irritation, redness. 
Otekanje, iritacija, rdečica.
• Chromaturia: all patients will show a dark red colouration of the urine quite marked during the first three days following administration. 
• Kromaturija: pri vseh bolnikih se bo v prvih treh dneh po uporabi pojavilo znatno temno rdeče obarvanje urina.
Read the leaflet for storage conditions in ambulatory use 
Za pogoje shranjevanja pri ambulantni uporabi glejte navodilo za uporabo.
If the decision is made to administer another cyanide antidote with Cyanokit, these medicinal products must not be administered concurrently in the same intravenous line (see section 6.2). 
Pri odločitvi za uporabo drugega antidota proti cianidu skupaj z zdravilom Cyanokit, se ta zdravila ne smejo dajati sočasno po isti intravenski liniji (glejte poglavje 6.2).
If the decision is made to administer another cyanide antidote with Cyanokit, these medicinal products must not be administered concurrently in the same intravenous line. 
Pri odločitvi za uporabo drugega antidota proti cianidu skupaj z zdravilom Cyanokit, se ta zdravila ne smejo dajati sočasno po isti intravenski liniji.
Observed in vitro interferences of hydroxocobalamin with laboratory tests 
Opažene motnje hidroksokobalamina pri laboratorijskih preiskavah in vitro
Pleural effusion, dyspnoea, throat tightness, dry throat, chest discomfort. 
Bolezni dihal, prsnega koša in mediastinalnega prostora Plevralni izliv, dispneja, stiskanje v grlu, suho grlo, neprijeten občutek v prsnem košu.
Artificially increased* 
Motnja ni opažena Umetno zvišan*
Chemical incompatibility was observed with the mixture of hydroxocobalamin reconstituted solution and the following medicinal products: epinephrine, lidocaine hydrochloride, adenosine, atropine, midazolam, ketamin, succinylcholine chloride, amiodarone hydrochloride, sodium bicarbonate, sodium thiosulfate, sodium nitrite, and has been reported with ascorbic acid. 
Kemijsko inkompatibilnost so opazili pri mešanju rekonstituirane raztopine hidroksokobalamina in naslednjih zdravil: epinefrin, lidokainijev klorid, adenozin, atropin, midazolam, ketamin, sukcinilholinijev klorid, amiodaronijev klorid, natrijev hidrogenkarbonat, natrijev tiosulfat, natrijev nitrit, o njej pa so poročali pri askorbinski kislini.
Renal and urinary problems 
Težave z ledvicami in urinom
Coagulation 
Koagulacija
• usual transport (15 days submitted to temperatures ranging from 5 to 40°C) 
• običajni prevoz (15 dni izpostavljenosti temperaturam od 5 °C do 40 °C),
What Cyanokit looks like and contents of the pack 
Izgled zdravila Cyanokit in vsebina pakiranja
Abdominal discomfort, dyspepsia, diarrhoea, vomiting, nausea, dysphagia. 
Neprijeten občutek v trebuhu, dispepsija, diareja, bruhanje, navzea, disfagija.
No special hazard for humans was identified based on conventional studies of single and repeated dose toxicity and genotoxicity. 
Običajne študije toksičnosti pri enkratnih in ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Headache; injection site reaction; peripheral oedema. 
Splošne težave in spremembe na mestu aplikacije Glavobol; reakcije na mestu injiciranja; periferni edem.
Mean corpuscular volume (MCV) Leucocytes 
Povprečni volumen eritrocitov (MCV) Levkociti
If these temporary conditions have been exceeded, the product should be discarded. 
Zdravilo je treba pri prekoračitvi teh začasnih pogojev zavreči.
Cyanokit powder for solution for infusion is a dark red crystalline powder supplied in a glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid. 
Zdravilo Cyanokit prašek za raztopino za infundiranje je temno rdeč kristaliničen prašek, ki je na voljo v stekleni viali, zaprti z zamaškom iz bromobutilne gume in aluminijasto zaporko s plastičnim pokrovom.
Cyanokit is an antidote for the treatment of known or suspected cyanide poisoning in all age ranges. 
Zdravilo Cyanokit je protistrup za zdravljenje znane zastrupitve s cianidom ali v primeru suma zastrupitve s cianidom za vse starostne skupine.
Reversible red colouration of the skin and mucous membranes: most patients will experience it up to 15 days after administration of Cyanokit. 
Reverzibilno rdeče obarvanje kože in sluznic: pri večini bolnikov se pojavi v do 15 dneh po dajanju zdravila Cyanokit.
* ≥ 10% interference observed on at least one analyser ** Artificially decreased using the diazo method *** Inconsistent results 
* ≥ 10 % motnje, opažene pri vsaj enem analizatorju.
Prothrombin time (PT) Quick or INR 
Quickov test ali INR
Decrease in the percentage of lymphocytes. 
Bolezni krvi in limfatičnega sistema Zmanjšanje odstotka limfocitov.
One intravenous infusion set. 
En komplet za intravensko infundiranje.
Monocytes 
Monociti
Survival at hour 4 and at day 14 was significantly greater in 75 mg/kg and 150 mg/kg hydroxocobalamin dose groups compared with dogs receiving sodium chloride 9 mg/mL alone: 
Preživetje po 4 urah in po 14 dnevu je bilo pri skupinah, ki so prejemale odmerke 75 mg/kg hidroksokobalamina in 150 mg/kg hidroksokobalamina, pomembno večje kot pri psih, ki so prejemali samo 9 mg/ml natrijevega klorida:
All patients will show a dark red colouration of the urine quite marked during the first three days following administration. 
Pri vseh bolnikih se bo v prvih treh dneh po uporabi pojavilo znatno temno rdeče obarvanje urina.
Effects on blood cyanide assay 
Učinki na preizkus cianida v krvi
The incidence of brain lesions was markedly lower in dogs having received 150 mg/kg hydroxocobalamin than in dogs having received 75 mg/kg hydroxocobalamin or sodium chloride 9 mg/mL. 
Pogostnost možganskih lezij je bila pri psih, ki so prejemali 150 mg/kg hidroksokobalamina, znatno manjša kot pri psih, ki so prejemali 75 mg/kg hidroksokobalamina ali 9 mg/ml natrijevega klorida.
Oxalate crystals have been observed in the urine of healthy volunteers given hydroxocobalamin. 
V urinu zdravih prostovoljcev, ki so dobili hidroksokobalamin, so opazili oksalatne kristale.
• Cyanide-poisoned patients 
• Bolniki, zastrupljeni s cianidom
Because of its deep red colour, hydroxocobalamin has the potential to induce a red colouration of the skin and therefore may interfere with burn assessment. 
Hidroksokobalamin je temno rdeč, zato lahko povzroči rdeče obarvanje kože in moti ocenjevanje stopnje opeklin.
Dogs were poisoned by intravenous administration of a lethal dose of potassium cyanide. 
Zastrupili so jih z intravenskim odmerjanjem smrtnega odmerka kalijevega cianida.
Cyanide poisoning may result from exposure to smoke from closed space fires, inhalation, ingestion, or dermal exposure. 
Zastrupitev s cianidom je lahko posledica izpostavljenosti dimu pri požaru v zaprtem prostoru, vdihavanja, zaužitja ali izpostavljenosti prek kože.
Cyanokit has been administered to this patient. 
Ta bolnik je prejel zdravilo Cyanokit.
• fluid in the chest (pleural effusion) 
• tekočina v prsnem košu (plevralni izliv)
Initial dose Adults: The initial dose of Cyanokit is 5 g (2 x 100 mL). 
Začetni odmerek Odrasli: Začetni odmerek zdravila Cyanokit je 5 g (2 x 100 ml).
The predominant mean half-life of free and total cobalamins-(III) was approximately 26 to 31 hours at the 5 and 10 g dose level. 
Pri odmerkih 5 in 10 g je bil prevladujoč povprečni razpolovni čas prostih in skupnih kobalaminov(III) približno 26 do 31 ur.
Administration of hydroxocobalamin was generally associated with a normalisation of blood pressure (systolic blood pressure > 90 mmHg) in 17 of 21 patients (81%) who had low blood pressure (systolic blood pressure > 0 and ≤ 90 mmHg) after exposure to cyanide. 
Pri 17 od 21 bolnikov (81%), ki so imeli po izpostavljenosti cianidu nizek krvni tlak (sistolični krvni tlak > 0 in ≤ 90 mmHg), je bila na splošno uporaba hidroksokobalamina povezana z normalizacijo krvnega tlaka (sistolični krvni tlak > 90 mmHg).
Chemical and physical in-use stability of the reconstituted solution with sodium chloride 9 mg/mL (0.9%) has been demonstrated for 6 hours at a temperature between 2°C and 40°C. 
Raztopina, rekonstituirana z raztopino natrijevega klorida 9 mg/ml (0,9 %) ostane kemično in fizikalno stabilna 6 ur pri temperaturi od 2 °C do 40 °C.
After reconstitution with 200 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin. 
Po rekonstituciji z 200 ml topila vsebuje en ml rekonstituirane raztopine 25 mg hidroksokobalamina.
Memory impairment; dizziness. 
Bolezni živčevja Motnje spomina; omotica.
• symptoms such as headache or dizziness, as they may be due to a rise in blood pressure. 
• simptomi, kot so glavobol ali omotica, ker so lahko posledica zvišanja krvnega tlaka; zvišanje krvnega tlaka se pojavlja zlasti ob koncu zdravljenja, krvni tlak pa se navadno vrne na izhodiščno vrednost v nekaj urah
Dogs then received sodium chloride 9 mg/mL, 75 mg/kg or 150 mg/kg hydroxocobalamin, administered intravenously over 7.5 minutes. 
Nato so jim v 7,5 minutah intravensko dali 9 mg/ml natrijevega klorida, 75 mg/kg hidroksokobalamina ali 150 mg/kg hidroksokobalamina.
The low molecular weight cobalamins-(III) formed including hydroxocobalamin are termed free cobalamins-(III); the sum of free and protein-bound cobalamins is termed total cobalamins-(III). 
Nastali kobalamini-(III) z majhno molsko maso, vključno s hidroksokobalaminom, se imenujejo prosti kobalamini-(III).
Transient, generally asymptomatic, increase in blood pressure may occur in patients receiving hydroxocobalamin. 
Pri bolnikih, ki prejemajo hidroksokobalamin, lahko pride do prehodnega, na splošno asimptomatičnega zvišanja krvnega tlaka.
After reconstitution with 100 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin. 
Po rekonstituciji s 100 ml topila vsebuje en ml rekonstituirane raztopine 25 mg hidroksokobalamina.
Calcium 
Kalcij
What Cyanokit contains 
Kaj vsebuje zdravilo Cyanokit
The rapid and complete recovery of haemodynamics and subsequently of blood gases, pH, and lactate after cyanide poisoning likely contributed to the better outcome of the hydroxocobalamin-treated animals. 
Pri živalih, ki so prejemale hidroksokobalamin, je po zastrupitvi s cianidom k boljšem izidu verjetno prispevalo hitro in popolno izboljšanje hemodinamike, s tem pa tudi vrednosti plinov v krvi, pH in laktata.
Adults: The subsequent dose of Cyanokit is 5 g (2 x 100 mL). 
Odrasli: Naslednji odmerek zdravila Cyanokit je 5 g (2 x 100 ml).
Type II colourless 250 mL glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid. 
250-mililitrska viala iz brezbarvnega stekla vrste II, zaprta z zamaškom iz bromobutilne gume in aluminijasto zaporko s plastičnim pokrovčkom.
• redness of the face (flush). 
• rdečica obraza (vročinski obliv)
Excipient: Hydrochloric acid (for pH adjustment). 
Pomožna snov: klorovodikova kislina (za uravnavanje pH).
The vial contains 5 g of hydroxocobalamin. 
Ena viala vsebuje 5 g hidroksokobalamina.
Paediatric population: In infants to adolescents (0 to 18 years old), the maximum total recommended dose is 140 mg/kg not exceeding 10 g. 
Pediatrična populacija: Od dojenčkov do mladostnikov (0 do 18 let starosti) je največji skupni priporočeni odmerek 140 mg/kg, vendar ne sme preseči 10 g.
Only when sodium chloride 9 mg/mL (0.9%) solution for injection is not available, Lactated Ringer solution or glucose 50 mg/mL (5%) solution for injection can also be used. 
Če natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje ni na voljo, se lahko uporabi raztopina Ringerjevega laktata ali glukoza 50 mg/ml (5 %) raztopina za injiciranje.
Cyanokit contains the active substance hydroxocobalamin. 
Zdravilo Cyanokit vsebuje zdravilno učinkovino hidroksokobalamin.
How Cyanokit is used 
Kako uporabljati zdravilo Cyanokit
Gamma glutamyl transferase (GGT) 
Gamaglutamiltransferaza (GGT)
Adults: The subsequent dose of Cyanokit is 5 g (200 mL, complete volume of reconstituted solution). 
Odrasli: Naslednji odmerek zdravila Cyanokit je 5 g (200 ml, celotna prostornina rekonstituirane raztopine).
Powder for solution for infusion containing 2.5 g of hydroxocobalamin. 
Prašek za raztopino za infundiranje, ki vsebuje 2,5 g hidroksokobalamina.
Powder for solution for infusion containing 5 g of hydroxocobalamin. 
Prašek za raztopino za infundiranje, ki vsebuje 5 g hidroksokobalamina.
Approximately 50 known or suspected cyanide victims aged 65 or older received hydroxocobalamin in clinical studies. 
V kliničnih študijah je hidroksokobalamin prejelo približno 50 bolnikov, starejših od 65 let, z znano zastrupitvijo s cianidom ali sumom nanjo.
Treatment of known or suspected cyanide poisoning in all age ranges. 
Zdravljenje znane zastrupitve s cianidom ali v primeru suma zastrupitve s cianidom za vse starostne skupine.
A total of 245 patients with suspected or known cyanide-poisoning were included in the clinical studies of the efficacy of hydroxocobalamin as an antidote. 
V kliničnih študijah učinkovitosti hidroksokobalamina kot antidota je sodelovalo skupaj 245 bolnikov z znano zastrupitvijo s cianidom ali sumom nanjo.
Cyanokit must not be mixed with diluents other than sodium chloride 9 mg/mL (0.9%) solution for injection or Lactated Ringer solution or glucose 50 mg/mL (5%) solution for injection. 
Sočasna uporaba zdravila Cyanokit in drugih zdravil Zdravilo Cyanokit se ne sme mešati z drugimi topili, razen z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje, raztopino Ringerjevega laktata ali glukozo 50 mg/ml (5 %) raztopino za injiciranje.
Similarly, mean free and total cobalamins-(III) Cmax values of 197 and 995 µg eq/mL, respectively, were determined following the dose of 10 g Cyanokit. 
Podobno je bila po 10-gramskem odmerku zdravila Cyanokit povprečna vrednost Cmax prostih kobalaminov-(III) 197, skupnih kobalaminov-(III) pa 995 µg eq/ml.
Type I colourless 250 mL glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid. 
250-mililitrska viala iz brezbarvnega stekla vrste I, zaprta z zamaškom iz bromobutilne gume in aluminijasto zaporko s plastičnim pokrovčkom.
Artificially decreased* 
** Umetno znižan z diazo metodo.
Sodium chloride 9 mg/mL (0.9%) solution for injection is the recommended diluent. 
Priporočeno topilo je natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje.
Each vial contains 2.5 g of hydroxocobalamin. 
Ena viala vsebuje 2,5 g hidroksokobalamina.
Duration of interference after a 5 g dose 
Umetno znižan* Nepredvidljiv*** Trajanje motnje po 5-gramskem odmerku
Developmental toxicity, including teratogenicity, was observed in rats and rabbits at dose levels of 150 mg/kg and higher administered daily throughout organogenesis. 
Pri podganah in kuncih so pri odmerkih 150 mg/kg in več, danih dnevno ves čas trajanja organogeneze, opazili toksičnost za razvoj, vključno s teratogenostjo.
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. 
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.
A decrease in blood pressure and a faster heart beat have also been observed in patients who have cyanide poisoning. 
Pri bolnikih, ki so se zastrupili s cianidom, so opazili tudi znižanje krvnega tlaka in hitrejše bitje srca.
Initial dose Adults: The initial dose of Cyanokit is 5 g (200 mL, complete volume of reconstituted solution). 
Odrasli: Začetni odmerek zdravila Cyanokit je 5 g (200 ml, celotna prostornina rekonstituirane raztopine).
Haematology Erythrocytes Haematocrit 
Hematologija Eritrociti Hematokrit
• swelling of ankles 
• otekanje gležnjev
Amylase 
Amilaza
In particular, liver fibrosis was observed in dogs after administration of hydroxocobalamin for 4 weeks at 300 mg/kg. 
Pri psih, ki so 4 tedne prejemali po 300 mg/kg hidroksokobalamina, so opazili predvsem fibrozo jeter.
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. 
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.
Eosinophils 
Eozinofilci
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). 
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.
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. 
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.
A decrease in blood pressure was observed in cyanide-poisoned patients. 
Pri bolnikih, zastrupljenih s cianidom, so opazili znižanje krvnega tlaka.
- haemodialysis. 
hemodializo.
Cyanokit 5 g powder for solution for infusion 
Cyanokit 5 g prašek za raztopino za infundiranje
Cyanokit 2.5 g powder for solution for infusion 
Cyanokit 2,5 g prašek za raztopino za infundiranje
Nervous system disorders 
Psihiatrične motnje Nemir.
Interference with haemodialysis 
Motnje delovanja hemodialize
Cyanokit 5 g powder for solution for infusion hydroxocobalamin 
Cyanokit 5 g prašek za raztopino za infundiranje hidroksokobalamin
Cyanokit 2.5 g powder for solution for infusion hydroxocobalamin 
Cyanokit 2,5 g prašek za raztopino za infundiranje hidroksokobalamin
The following adverse reactions have been reported in association with Cyanokit use. 
Pri uporabi zdravila Cyanokit so poročali o naslednjih neželenih učinkih.
No data are available on male and female fertility as well as on peri- and postnatal development. 
Podatkov o plodnosti pri samcih in samicah ter o peri- in postnatalnem razvoju ni. Kancerogenega potenciala hidroksokobalamina niso ocenjevali.
The vial is to be reconstituted with 200 mL of diluent using the supplied sterile transfer device. 
S priloženo sterilno napravo za prenos je treba vialo rekonstituirati z 200 ml topila.
• Elderly 
• driska
How Cyanokit is stored 
Shranjevanje zdravila Cyanokit
Each vial is to be reconstituted with 100 mL of diluent using the supplied sterile transfer device. 
S priloženo sterilno napravo za prenos je treba vsako vialo rekonstituirati s 100 ml topila.
STATEMENT OF ACTIVE SUBSTANCE(S) 
Protrombinski čas (PT)
An increase in heart rate was observed in cyanide-poisoned patients. 
Pri bolnikih, zastrupljenih s cianidom, so opazili pospešen srčni utrip.
Potassium Chloride 
Klorid
Such side effects may be serious and need immediate attention. 
• rdečica kože, koprivnica (urtikarija) ali srbenje Ti neželeni učinki so lahko resni in zahtevajo takojšnje ukrepanje.
Uric acid 
Bolezni ledvic
• restlessness 
• omotica
Hydrochloric acid (for pH-adjustment) 
6.1 Seznam pomožnih snovi Klorovodikova kislina (za uravnavanje pH)
• swelling, irritation, redness. 
• otekanje, draženje, rdečica Kožne reakcije
Unpredictable*** 
*** Nekonsistentni rezultati.
Posology 
Sečnina
Psychiatric disorders 
Bolezni sečil
Cases have also been reported in other Member States leading to regulatory actions. 
Tudi v drugih državah članicah so poročali o primerih, kar je privedlo do regulatornih ukrepov.
The risk of sensitisation has been investigated in various studies published in recent years. 
Tveganje za preobčutljivost so proučevali v različnih študijah, objavljenih v preteklih letih.
Home Products de Portugal, Lda. 
Portugalska Home Products de Portugal,Lda.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING BUFEXAMAC (see Annex I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO BUFEKSAMAK (glejte Dodatek I)
In addition, the Committee considered that the proposed risk minimisation measures are not appropriate to reduce the risks to an acceptable level. 
Poleg tega je Odbor štel predlagane ukrepe za zmanjšanje tveganja kot neustrezne za zmanjšanje tveganja na sprejemljivo raven.
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. 
Nemški medicinski tednik) 2005; zvezek 130; 50: 2881-2886) dokazujejo povečano tveganje za alergijski kontaktni dermatitis pri splošni populaciji bolnikov, ki uporabljajo bufeksamak.
Therefore the Committee recommended the revocation of the Marketing Authorisations for the medicinal products referred to in Annex I. 
Odbor je zato priporočil odvzem dovoljenj za promet z zdravili, ki so navedena v Dodatku I.
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. 
CHMP je proučil zadevo v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, na plenarnem zasedanju CHMP aprila 2010.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ODVZEM DOVOLJENJ ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
• to reduce symptoms of 1st and 2nd grade haemorrhoids. 
• zmanjšanje simptomov hemoroidov prve in druge stopnje.
Many reports described massive, generalised reactions, some of them requiring systemic treatment with corticosteroids or hospitalisation. 
V mnogih poročilih so opisovali obsežne, generalizirane reakcije, pri nekaterih od njih pa je bilo potrebno sistemsko zdravljenje s kortikosteroidi ali hospitalizacija.
In addition, recent publications on contact allergy (e.g. Gniazdowska 1999, Waltermamm 2009), confirmed that the efficacy of bufexamac in skin diseases is questionable. 
Poleg tega so nedavne publikacije o kontaktni alergiji (npr. Gniazdowska 1999, Waltermamm 2009) potrdile, da je učinkovitost bufeksamaka pri kožnih boleznih vprašljiva.
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. 
CHMP zato meni, da izpostavljenost bufeksamaku povečuje tveganje za pojav kontaktnih alergijskih reakcij in v nekaterih primerih celo podaljša trajanje bolezni.
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. 
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.
Risk 
Tveganje
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. 
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.
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. 
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.