FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of its deep red color, hydroxocobalamin may cause haemodialysis machines to shut down due to an erroneous detection of a ‘blood leak'.
Danish: Da hydroxocobalamin har en dyb rød farve, kan det forårsage, at hæmodialysemaskiner lukker ned på grund af en fejlagtigt detekteret 'blodlækage'.
English: Restlessness.
Danish: Rastløshed.
English: 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.
Danish: Hvis det besluttes at administrere en anden cyanid-antidot sammen med Cyanokit, må disse lægemidler ikke administreres samtidig gennem samme intravenøse adgang.
English: Creatine kinase (CK) Creatine kinase isoenzym MB (CKMB)
Danish: Aspartataminotransferase (ASAT) Kreatinkinase (CK) Kreatinkinaseisoenzym MB (CKMB)
English: A decrease in blood pressure was observed in cyanide-poisoned patients.
Danish: Der blev observeret et fald i blodtrykket hos cyanidforgiftede patienter.
English: Pleural effusion, dyspnoea, throat tightness, dry throat, chest discomfort.
Danish: Pleural effusion, dyspnø, tæthedsfornemmelse i halsen, tør hals, ubehag i brystet.
English: What Cyanokit contains
Danish: Cyanokit indeholder:
English: Cyanide poisoning may result from exposure to smoke from closed space fires, inhalation, ingestion, or dermal exposure.
Danish: Cyanidforgiftning kan opstå som følge af udsættelse for røggasser (brand) i lukkede rum, inhalation, indtagelse eller dermal eksponering.
English: 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.
Danish: Da hydroxocobalamin er mørkerødt, kan det føre til en rødfarvning af huden og kan derfor interferere med vurderingen af forbrændinger.
English: Results may vary considerably from one analyser to another, therefore, caution is required when reporting and interpreting laboratory results.
Danish: Der skal derfor udvises forsigtighed, når resultaterne af disse laboratorieprøver rapporteres og fortolkes.
English: 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.
Danish: Der blev observeret kemisk uforligelighed ved blanding af rekonstitueret hydroxocobalamin og følgende lægemidler: adrenalin, lidocainhydrochlorid, adenosin, atropin, midazolam, ketamin, succinylcholinchlorid, amiodaronhydrochlorid, natriumhydrogencarbonat, natriumthiosulfat samt natriumnitrit, og det er blevet rapporteret med ascorbinsyre.
English: 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.
Danish: Der er påvist kemisk og fysisk stabilitet af den rekonstituerede opløsning med natriumchlorid 9 mg/ml (0,9 %) i 6 timer ved en temperatur på mellem 2 °C og 40 °C.
English: • freezing/defrosting cycles (15 days submitted to temperatures ranging from -20 to 40°C).
Danish: • nedfrysnings-/optøningscyklusser (15 dage med temperaturer mellem -20 °C og 40 °C)
English: • kidney injuries such as acute kidney impairment and urine crystals.
Danish: • nyreskader, såsom akut nedsat nyrefuntkion og krystaller i urinen.
English: • Chromaturia: all patients will show a dark red colouration of the urine quite marked during the first three days following administration.
Danish: • Kromaturi: urinen vil hos alle patienten få en ret markant rød farve i løbet af de første 3 dage efter administration.
English: In vitro tests indicate that the extent and duration of the interference is dependant on numerous factors such as the dose of hydroxocobalamin, analyte, analyte concentration, methodology, analyser, concentrations of cobalamins-(III) including cyanocobalamin and partially the time between sampling and measurement.
Danish: In vitro-prøver indikerer, at graden og varigheden af denne interferens afhænger af en række faktorer, som f.eks. doseringen af hydroxocobalamin, analyten, analytkoncentrationen, metoden, analysatoren,
English: Analysers used: ACL Futura (Instrumentation Laboratory), Axsym/Architect (Abbott), BM Coasys (Boehringer Mannheim), CellDyn 3700 (Abbott), Clinitek 500 (Bayer), Cobas Integra 700, 400 (Roche), Gen-S Coultronics, Hitachi 917, STA
Danish: (Boehringer Mannheim), CellDyn 3700 (Abbott), Clinitek 500 (Bayer), Cobas Integra 700, 400 (Roche), Gen-S Coultronics, Hitachi 917, STA Compact, Vitros 950 (Ortho Diagnostics)
English: Swelling, irritation, redness.
Danish: Hævelse, irritation, rødme.
English: Alanine aminotransferase (ALT)
Danish: Alaninaminotransferase (ALAT) Amylase
English: • usual transport (15 days submitted to temperatures ranging from 5 to 40°C)
Danish: • almindelig transport (15 dage med temperaturer mellem 5 °C og 40 °C)
English: Detailed information for your doctor or other health care professional regarding simultaneous administration of Cyanokit with other medicines can be found at the end of this package leaflet (see 'Handling instructions').
Danish: Der findes detaljerede oplysninger til din læge eller andet sundhedspersonale om, hvordan Cyanokit anvendes sammen med anden medicin sidst i denne indlægsseddel (se 'Håndtering').
English: A total of 347 subjects were exposed to hydroxocobalamin in clinical studies.
Danish: I alt blev hydroxocobalamin testet hos 347 forsøgspersoner i kliniske studier.
English: How Cyanokit is used
Danish: Sådan skal Cyanokit bruges
English: The action of hydroxocobalamin in the treatment of cyanide poisoning is based on its ability to tightly bind cyanide ions.
Danish: Hydroxocobalamins virkning ved behandling af cyanidforgiftning er baseret på, at det kan binde cyanid-ioner med en høj bindingsstyrke.
English: An increase in heart rate was observed in cyanide-poisoned patients.
Danish: Der blev observeret en stigning i hjertefrekvensen hos cyanidforgiftede patienter.
English: One transfer device.
Danish: En overføringskanyle.
English: 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.
Danish: Incidensen af hjernelæsioner var markant lavere hos de hunde, der fik 150 mg/kg hydroxocobalamin sammenlignet med de hunde, der fik 75 mg/kg hydroxocobalamin eller 9 mg/ml natriumchlorid.
English: • redness of the face (flush).
Danish: • rødme i ansigtet (hedestigning).
English: Cyanokit is to be administered together with appropriate decontamination and supportive measures.
Danish: Behandlingen med Cyanokit skal foretages samtidig med, at der gennemføres passende afgiftning og understøttende behandling.
English: However, if a cyanide blood level determination is planned, it is recommended to draw the blood sample before initiation of treatment with Cyanokit.
Danish: Hvis man alligevel ønsker at påvise cynanidniveauet i blodet, anbefales det, at blodprøven tages, før behandlingen med Cyanokit indledes.
English: • swelling, irritation, redness.
Danish: • hævelse, irritation, rødme.
English: Urine colouration may last up to 35 days after administration of Cyanokit.
Danish: Urinen kan blive ved med at være farvet i op til 35 dage efter behandlingen med Cyanokit.
English: All patients will show a dark red colouration of the urine quite marked during the first three days following administration.
Danish: Alle patienter får en stærk rødfarvning af urinen i de første tre dage efter behandlingen.
English: Monocytes
Danish: Monocytter
English: • swelling of ankles
Danish: • hævede ankler
English: No special hazard for humans was identified based on conventional studies of single and repeated dose toxicity and genotoxicity.
Danish: Baseret på konventionelle studier af toksiciteten efter både én og gentagne doser samt genotoksicitet, blev det ikke identificeret nogen specielle risici for mennesker.
English: 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.
Danish: Cyanokit pulver til infusionsvæske, opløsning, er et mørkerødt, krystallinsk pulver, der leveres i et hætteglas, som er lukket med en bromobutylgummiprop og et aluminiumslåg med en plastikmembran.
English: Urine colouration may last up to 35 days after administration of Cyanokit (see section 4.4 ).
Danish: Farvningen af urinen kan vare i 35 dage efter administration af Cyanokit (se pkt.
English: • Animal pharmacology
Danish: • Dyrefarmakologi
English: Gamma glutamyl transferase (GGT)
Danish: Gammaglutamyltransferase (GGT)
English: What Cyanokit is and what it is used for What you need to know before Cyanokit is used How Cyanokit is used
Danish: Virkning og anvendelse Det skal du vide, før Cyanokit bruges Sådan skal Cyanokit bruges Bivirkninger
English: Transient, generally asymptomatic, increase in blood pressure may occur in patients receiving hydroxocobalamin.
Danish: Det kan forekomme, at blodtrykket stiger hos de patienter, der får hydroxocobalamin.
English: 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).
Danish: Hvis det besluttes at administrere en anden cyanid-antidot sammen med Cyanokit, må disse lægemidler ikke administreres samtidig gennem samme intravenøse adgang (se pkt.
English: 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:
Danish: Overlevelsesraten efter 4 timer og efter 14 dage var væsentlig højere i de dosisgrupper, der fik hydroxocobalamin 75 mg/kg og 150 mg/kg, sammenlignet med de hunde, der kun fik natriumchlorid 9 mg/ml:
English: Each pack contains two vials (each vial packed in one cardboard box), two sterile transfer devices, one sterile intravenous infusion set and one sterile short catheter for administration to children.
Danish: Hver pakning indeholder to hætteglas (hvert hætteglas er pakket i en papæske), to sterile overføringskanyler, et sterilt intravenøst infusionssæt og et sterilt kort kateter til administration til børn.
English: • skin redness, nettle rash (urticaria) or itching.
Danish: • rødme i huden, nældefeber (urticaria) eller kløe.
English: Each pack contains one vial packed in one cardboard box, one sterile transfer device, one sterile intravenous infusion set and one sterile short catheter for administration to children.
Danish: Hver pakning indeholder et hætteglas pakket i en papæske, én steril overføringskanyle, et sterilt intravenøst infusionssæt og et sterilt kort kateter til administration til børn.
English: In the absence of data in breast-fed infants, breast-feeding discontinuation is recommended after receiving Cyanokit.
Danish: Da der ikke findes data angående spædbørn, der ammes, tilrådes det at stoppe amningen efter administration af Cyanokit.
English: If a cyanide blood level determination is planned, it is recommended to draw the blood sample before initiation of treatment with Cyanokit.
Danish: Ønsker man at påvise cynanidnivauet i blodet, anbefales det, at blodprøven tages, før behandlingen med Cyanokit indledes.
English: Paediatric population: In infants to adolescents (0 to 18 years old), the maximum total recommended dose is 140 mg/kg not exceeding 10 g.
Danish: Pædiatrisk population: Hos spædbørn, børn og unge (i alderen 0 til 18 år) er den maksimale totale anbefalede dosis 140 mg/kg, dog højst 10 g.
English: Renal and urinary problems
Danish: Problemer med nyrerne og urinen
English: Neutrophils
Danish: Neutrofile
English: Smoke inhalation
Danish: Indånding af røggasser
English: 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.
Danish: Cyanokit må kun blandes med natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion eller Ringers lactat eller glucose 50 mg/ml (5 %) injektionsvæske, opløsning.
English: Type II colourless 250 mL glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.
Danish: Farveløse type II-hætteglas, 250 ml, som er lukket med en bromobutylgummiprop og et aluminiumslåg med en plastikmembran.
English: Phosphate
Danish: Fosfat
English: Of these 347 subjects, 245 patients had suspected exposure to cyanide at the time of hydroxocobalamin administration.
Danish: På tidspunktet for administrationen af hydroxocobalamin var der mistanke om eksponering for cyanid hos 245 af de 347 patienter.
English: MEDICAL OR HEALTH CARE PROFESSIONALS EDUCATIONAL STICKER
Danish: SELVKLÆBENDE ETIKET MED INFORMATION TIL LÆGER OG SUNDHEDSPERSONALE
English: Effects on blood cyanide assay
Danish: Indvirkning på cyanidblodprøve
English: Excipient: Hydrochloric acid (for pH adjustment).
Danish: Hjælpestof: Saltsyre (til justering af pH).
English: Cyanide poisoning may be caused by exposure to smoke from household and industrial fires, breathing or swallowing cyanide, or contact with cyanide on skin.
Danish: Cyanidforgiftning kan forårsages af røggasser, som indåndes i forbindelse med brand i hjemmet eller industribrand.
English: Type I colourless 250 mL glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.
Danish: Farveløse type I-hætteglas, 250 ml, som er lukket med en bromobutylgummiprop og et aluminiumslåg med en plastikmembran.
English: The 75 mg/kg and 150 mg/kg doses are approximately equivalent to 5 g and 10 g of hydroxocobalamin, respectively, in humans, not only on a body weight basis but also on Cmax basis of hydroxocobalamin [total cobalamins-(III), see section 5.2].
Danish: Derefter fik hundene natriumchlorid 9 mg/ml, 75 mg/kg eller 150 mg/kg hydroxocobalamin, der blev administreret intravenøst i 7,5 min. Doserne på 75 mg/kg og 150 mg/kg svarede omtrent til henholdsvis 5 g og 10 g hydroxocobalamin hos mennesker, ikke kun på basis af legemsvægt, men også på basis af Cmax for hydroxocobalamin [totale cobalamin-(III)-ioner, se pkt.
English: • blister-like lesions on the skin (pustular rashes).
Danish: • udslæt med blærer på huden (pustuløst udslæt).
English: Adults: The subsequent dose of Cyanokit is 5 g (2 x 100 mL).
Danish: Voksne: Den efterfølgende dosis Cyanokit er 5 g (2 x 100 ml).
English: Depending upon the severity of the poisoning and the clinical response (see section 4.4), a second dose may be administered.
Danish: Afhængigt af forgiftningens sværhedsgrad og den kliniske respons (se pkt.
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.
Danish: Pædiatrisk population: Hos spædbørn, børn og unge (i alderen 0 til 18 år) er den efterfølgende dosis Cyanokit 70 mg/kg legemsvægt, dog højst 5 g.
English: Mean corpuscular haemoglobin (MCH) Mean corpuscular haemoglobin concentration (MCHC)
Danish: Middelcellehæmoglobin (MCH) Middelcellehæmoglobinkoncentration (MCHC)
English: However, hydroxocobalamin because of its deep red colour may interfere with the performance of haemodialysis machines (see section 4.4).
Danish: Hydroxocobalamins dybe røde farve kan dog påvirke ydeevnen af hæmodialysemaskiner (se pkt.
English: Initial dose Adults: The initial dose of Cyanokit is 5 g (2 x 100 mL).
Danish: Initialdosis Voksne: Den initiale dosis Cyanokit er 5 g (2 x 100 ml).
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.
Danish: Pædiatrisk population: Hos spædbørn, børn og unge (i alderen 0 til 18 år) er den initiale dosis Cyanokit 70 mg/kg legemsvægt, dog højst 5 g.
English: Adults: The subsequent dose of Cyanokit is 5 g (200 mL, complete volume of reconstituted solution).
Danish: Voksne: Den efterfølgende dosis Cyanokit er 5 g (200 ml, fuldstændigt volumen af rekonstitueret opløsning).
English: Following intravenous administration of Cyanokit, significant binding to plasma proteins and low molecular weight physiological compounds occurs, to form various cobalamin-(III) complexes by replacing the hydroxo ligand.
Danish: Efter intravenøs administration af Cyanokit forekommer der en signifikant binding til plasmaproteiner og fysiologiske stoffer med lav molekylær vægt.
English: 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.
Danish: Kun i de tilfælde hvor natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, ikke er tilgængelig, kan der anvendes Ringers lactat eller glucose 50 mg/ml (5 %) injektionsvæske, opløsning, i stedet.
English: Sodium chloride 9 mg/mL (0.9%) solution for injection is the recommended diluent.
Danish: Den anbefalede solvens er natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: Haematology Erythrocytes Haematocrit
Danish: Hæmatologi Erytrocytter Hæmatokrit
English: Eosinophils
Danish: Eosinofile
English: Each vial contains 2.5 g of hydroxocobalamin.
Danish: Hvert hætteglas indeholder 2,5 g hydroxocobalamin.
English: Other medicines and Cyanokit
Danish: Brug af anden medicin sammen med Cyanokit
English: Initial dose Adults: The initial dose of Cyanokit is 5 g (200 mL, complete volume of reconstituted solution).
Danish: Initialdosis Voksne: Den initiale dosis Cyanokit er 5 g (200 ml, fuldstændigt volumen af rekonstitueret opløsning).
English: Mean corpuscular volume (MCV) Leucocytes
Danish: Middelcellevolumen (MCV)
English: Powder for solution for infusion Two vials
Danish: Pulver til infusionsvæske, opløsning To hætteglas
English: Sodium
Danish: Kalium
English: The vial contains 5 g of hydroxocobalamin.
Danish: Hætteglasset indeholder 5 g hydroxocobalamin.
English: After reconstitution with 100 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin.
Danish: Efter rekonstituering med 100 ml solvens indeholder hver ml af den rekonstituerede opløsning 25 mg hydroxocobalamin.
English: After reconstitution with 200 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin.
Danish: Efter rekonstituering med 200 ml solvens indeholder hver ml af den rekonstituerede opløsning 25 mg hydroxocobalamin.
English: Hydrochloric acid (for pH-adjustment)
Danish: Saltsyre (til justering af pH).
English: 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.
Danish: På samme måde blev de gennemsnitlige Cmax-værdier for frie og totale cobalamin-(III)-ioner på hhv. 197 og 995 µg eq/ml påvist efter en dosis Cyanokit på 10 g. Den overvejende gennemsnitlige halveringstid for frie og totale cobalamin-(III)-ioner var ca. 26 til 31 timer ved et dosisniveau på 5 og 10 g.
English: Potassium Chloride
Danish: Klinisk kemi Calcium Natrium
English: Cyanokit 5 g powder for solution for infusion Hydroxocobalamin
Danish: Cyanokit 5 g pulver til infusionsvæske, opløsning Hydroxocobalamin
English: Cyanokit 2.5 g powder for solution for infusion hydroxocobalamin
Danish: Cyanokit 2,5 g pulver til infusionsvæske, opløsning Hydroxocobalamin
English: Cyanokit 2.5 g powder for solution for infusion
Danish: Cyanokit 2,5 g pulver til infusionsvæske, opløsning
English: Cyanokit 5 g powder for solution for infusion
Danish: Cyanokit 5 g pulver til infusionsvæske, opløsning
English: CARDBOARD BOX
Danish: Mave-tarm-kanalen
English: • chest pressure.
Danish: • trykken for brystet.
English: The vial is to be reconstituted with 200 mL of diluent using the supplied sterile transfer device.
Danish: Hætteglasset skal rekonstitueres med 200 ml solvens.
English: Platelets
Danish: Karbamid
English: Amylase
Danish: Amning
English: Although the safety and efficacy of hydroxocobalamin have not been studied in renal and hepatic impairments, Cyanokit is administered as emergency therapy in an acute, life-threatening situation only and no dose adjustment is required in these patients.
Danish: Cyanokit administreres kun som akutbehandling i en livstruende situation.
English: Calcium
Danish: Chlorid
English: Powder for solution for infusion One vial
Danish: Pulver til infusionsvæske, opløsning Et hætteglas
English: • The other ingredient is hydrochloric acid (for pH adjustment).
Danish: • Øvrigt indholdsstof: saltsyre (til justering af pH) Udseende og pakningsstørrelser
English: Interference with haemodialysis
Danish: Interferens med hæmodialyse
English: - haemodialysis.
Danish: hæmodialyse.
English: Handling instructions
Danish: Hudreaktioner
English: Each vial is to be reconstituted with 100 mL of diluent using the supplied sterile transfer device.
Danish: Hvert hætteglas skal rekonstitueres med 100 ml solvens.
English: VIAL
Danish: Fordøjelsen
English: Cases have also been reported in other Member States leading to regulatory actions.
Danish: Der er også blevet indberettet tilfælde i andre medlemsstater, som har medført regulerende foranstaltninger.
English: The risk of sensitisation has been investigated in various studies published in recent years.
Danish: Risikoen for sensibilisering er blevet undersøgt i en række forskellige undersøgelser, der er blevet offentliggjort i de seneste år.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING BUFEXAMAC (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE BUFEXAMAC (se bilag I)
English: In addition, the Committee considered that the proposed risk minimisation measures are not appropriate to reduce the risks to an acceptable level.
Danish: Udvalget var desuden af den opfattelse, at de foreslåede foranstaltninger til risikominimering ikke er egnede til at nedbringe risiciene til et acceptabelt niveau.
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.
Danish: Deutsche Medizinische Wochenschrift 2005; Vol. 130; 50: 2881-2886) giver evidens for en øget risiko for allergisk kontaktdermatitis i den generelle population af patienter, der bruger bufexamac.
English: • to reduce symptoms of 1st and 2nd grade haemorrhoids.
Danish: • til at reducere symptomer på første- og andengradshæmorider.
English: Risk
Danish: Risiko
English: Controlled studies demonstrated lower efficacy of bufexamac than active comparators or no difference to placebo.
Danish: Kontrollerede undersøgelser viser, at effektiviteten af bufexamac er lavere end effektiviteten af det aktive sammenligningsstof eller ingen forskel i forhold til placebo.
English: Many reports described massive, generalised reactions, some of them requiring systemic treatment with corticosteroids or hospitalisation.
Danish: I mange indberetninger beskrives der massive, generaliserede reaktioner, hvoraf nogle kræver systemisk behandling med kortikosteroider eller indlæggelse.
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.
Danish: Endvidere bekræftes det i nylige publikationer om kontaktallergi (f.eks. Gniazdowska 1999, Waltermamm 2009), at effektiviteten af bufexamac i behandling af hudsygdomme er tvivlsom.
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.
Danish: Derudover vedrører hovedparten af de 450 kasuistikker om bufexamac i bivirkningsdatabasen hos den kompetente nationale myndighed (BfArM, DE) bivirkninger på huden eller immunsystemet, herunder 189 tilfælde af kontaktdermatitis.